58
Code Product Unit EPY0000055 EPY0000116 EPY0000500 EPY0000354 EPY0000427 EPA0040000 EPY0000359 Acamprosate calcium - Reference Spectrum Acamprosate impurity A 3-aminopropane-1-sulphonic acid Acarbose Acarbose for identification Acarbose for peak identification Acebutolol hydrochloride Acebutolol impurity B N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl]acetamide (diacetolol) Acebutolol impurity C N-(3-acetyl-4-hydroxyphenyl)butanamide Acebutolol impurity I N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)butanamide Aceclofenac - Reference Spectrum Aceclofenac for peak identification Aceclofenac impurity F benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate Aceclofenac impurity H [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid Acemetacin Acemetacin impurity A 4-chlorobenzoic acid Acemetacine impurity mixture Acesulfame potassium Acesulfame potassium impurity B 5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide Acetazolamide Acetazolamide for system suitability Acetylcholine chloride Acetylcysteine Acetylcysteine impurity C N,N'-diacetyl-L-cystine Acetylcysteine impurity D N,S-diacetyl-L-cysteine ß-Acetyldigoxin β-Acetyldigoxin for peak identification Acetylsalicylic acid Acetylsulfadiazine N-Acetyltryptophan N-Acetyltyrosine Acholeplasma laidlawii BRP Aciclovir Aciclovir for system suitability Aciclovir for peak identification 1 Aciclovir for peak identification 2 Actaea racemosa HRS Actaea racemosa for assay CRS Acitretin Actaea rasemosa dry extract for system suitability HRS Adapalene Adapalene impurity C 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane Adapalene for peak identification Adenine unit 50 mg 94.7 mg 10 mg 40 mg 50 mg 10 mg EPY0000127 EPY0000128 EPY0000056 EPY0001094 EPY0000085 EPY0000086 EPY0000810 EPY0000811 EPY0000842 EPA0070000 EPA0070020 EPA0100000 EPY0001084 EPY0000002 EPA0150000 EPA0152000 EPA0153000 EPY0000565 EPY0000642 EPA0200000 New EPY0001462 EPA0208000 EPA0202000 EPY0000693 EPA0220000 EPY0001264 EPY0001271 EPY0001269 New EPY0001463 New EPY0001543 EPA0225000 New EPY0001464 EPY0001121 EPY0001120 EPY0001119 EPA0230000 20 mg 0.004 mg unit 10 mg 20 mg 10 mg 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004 mg 1200 mg 300 mg 100 mg 1200 mg 100 mg 6 mg 2.022 mg 50 mg Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 251

Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

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Page 1: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Code Product Unit

EPY0000055

EPY0000116

EPY0000500

EPY0000354

EPY0000427

EPA0040000

EPY0000359

Acamprosate calcium - Reference Spectrum

Acamprosate impurity A 3-aminopropane-1-sulphonic acid

Acarbose

Acarbose for identification

Acarbose for peak identification

Acebutolol hydrochloride

Acebutolol impurity B N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl]acetamide (diacetolol)

Acebutolol impurity C N-(3-acetyl-4-hydroxyphenyl)butanamide

Acebutolol impurity I N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)butanamide

Aceclofenac - Reference Spectrum

Aceclofenac for peak identification

Aceclofenac impurity F benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate

Aceclofenac impurity H [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid

Acemetacin

Acemetacin impurity A 4-chlorobenzoic acid

Acemetacine impurity mixture

Acesulfame potassium

Acesulfame potassium impurity B 5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide

Acetazolamide

Acetazolamide for system suitability

Acetylcholine chloride

Acetylcysteine

Acetylcysteine impurity C N,N'-diacetyl-L-cystine

Acetylcysteine impurity D N,S-diacetyl-L-cysteine

ß-Acetyldigoxin β-Acetyldigoxin for peak identification

Acetylsalicylic acid

Acetylsulfadiazine

N-Acetyltryptophan

N-Acetyltyrosine

Acholeplasma laidlawii BRP

Aciclovir

Aciclovir for system suitability

Aciclovir for peak identification 1

Aciclovir for peak identification 2

Actaea racemosa HRS

Actaea racemosa for assay CRS

Acitretin

Actaea rasemosa dry extract for system suitability HRS

Adapalene

Adapalene impurity C 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane

Adapalene for peak identification

Adenine

unit

50 mg

94.7 mg

10 mg

40 mg

50 mg

10 mg

EPY0000127

EPY0000128

EPY0000056

EPY0001094

EPY0000085

EPY0000086

EPY0000810

EPY0000811

EPY0000842

EPA0070000

EPA0070020

EPA0100000

EPY0001084

EPY0000002

EPA0150000

EPA0152000

EPA0153000

EPY0000565

EPY0000642

EPA0200000

New EPY0001462

EPA0208000

EPA0202000

EPY0000693

EPA0220000

EPY0001264

EPY0001271

EPY0001269

New EPY0001463

New EPY0001543

EPA0225000

New EPY0001464

EPY0001121

EPY0001120

EPY0001119

EPA0230000

20 mg

0.004 mg

unit

10 mg

20 mg

10 mg

100 mg

10 mg

0.06 mg

50 mg

50 mg

100 mg

0.0068 mg

50 mg

50 mg

10 mg

10 mg

50 mg

10 mg

15 mg

0.002 mg

125 mg

200 mg

1 mL

75 mg

10 mg

0.3 mg

0.004 mg

1200 mg

300 mg

100 mg

1200 mg

100 mg

6 mg

2.022 mg

50 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 251

Page 2: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPA0230200

EPY0000110

EPY0000882

EPY0000883

EPA0300000

EPY0000740

EPY0000707

EPY0000728

EPA0325000

EPA0325100

EPA0325200

EPA0325450

EPA0325451

EPA1225000

EPA0325500

EPA0325800

EPY0000832

EPA0349000

EPA0350000

EPA0350010

EPA0350020

EPA0350030

EPA0350040

EPA0350050

EPA0351000

EPY0000235

EPY0000255

EPA0357000

EPA0360000

EPY0000054

EPY0000606

EPY0000843

EPY0000687

EPY0000595

EPY0000607

EPA0363000

EPA0363700

EPA0900000

EPA0365000

EPA0368000

New EPY0001467

EPA0365900

EPY0001117

EPA0370000

EPY0000020

Adenosine

Adipic acid

Adrenaline

Adrenaline with impurity F

Adrenaline tartrate

Adrenaline impurity mixture

Adrenaline tartrate with impurity A

Agnus castus fruit standardised dry extract

Alanine

Albendazole

Alcuronium chloride

Alfacalcidol

Alfacalcidol - Reference Spectrum

Alfadex

Alfentanil hydrochloride - Reference Spectrum

Alfuzosin hydrochloride

Alfuzosin for system suitability

Allantoin

Allopurinol

Allopurinol impurity A 5-amino-1H-pyrazole-4-carboxamide

Allopurinol impurity B 5-formylamino-1H-pyrazole-4-carboxamide

Allopurinol impurity C 5-(4H-1,2,4-triazol-4-yl)1H-pyrazole-4-carboxamide

Allopurinol impurity D ethyl 5-amino-1H-pyrazole-4-carboxylate

Allopurinol impurity E ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate

Allylstrychnine bromide

Almagate

Almagate - Reference Spectrum

Alprazolam Controlled Substance

Alprenolol hydrochloride

Alprostadil

Altizide

Altizide impurity B 3-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene

Alverine citrate

Alverine for peak identification

Alverine impurity D N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine

Amantadine hydrochloride

Ambroxol hydrochloride

Amfetamine sulfate - Reference Spectrum

Amidotrizoic acid dihydrate

Amikacin

Amikacin impurity I (2S)-4-amino-2-hydroxybutanoic acid

Amikacin sulfate

Amikacin for system suitability

Amiloride hydrochloride

Amiloride impurity A methyl-3,5-diamino-6-chloropyrazine-2-carboxylate

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg

50 mg

5 mg

10 mg

100 mg

0.005 mg

15 mg

200 mg

60 mg

50 mg

50 mg

5 mg

unit

150 mg

unit

10 mg

10 mg

60 mg

100 mg

10 mg

10 mg

10 mg

10 mg

20 mg

10 mg

25 mg

unit

100 mg

100 mg

50 mg

150 mg

15 mg

5 mg

0.125 mg

10 mg

100 mg

125 mg

unit

100 mg

200 mg

20 mg

200 mg

10 mg

100 mg

10 mg

252 Edition 2012/2013

Page 3: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000173

EPA0420000

EPA0460000

EPA0496000

EPA0496005

4-Aminobenzoic acid

Aminocaproic acid

7-Aminodesacetoxycephalosporanic acid

Aminoglutethimide

Aminoglutethimide impurity A (3RS)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide)

Aminoglutethimide impurity D 3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione) (azoglutethimide)

Amiodarone hydrochloride

Amiodarone impurity D (2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone

Amiodarone impurity E (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone

Amisulpride

Amisulpride impurity B 4-amino-N-[[(2RS )-1-ethylpyrrolidin-2-yl] methyl]-5-(ethyl sulphonyl)-2-hydroxybenzamide

Amitriptyline hydrochloride

Amlodipine besilate

Amlodipine for peak identification

Amlodipine impurity A 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2- yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

Amlodipine impurity B 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2- (methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate

Amlodipine impurity G dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

Ammonio methacrylate copolymer (type A) - Reference Spectrum

Ammonio methacrylate copolymer (type B) - Reference Spectrum

Amobarbital Controlled Substance

Amobarbital sodium Controlled Substance

Amoxicillin trihydrate

Amphotericin B

Amphotericin B for microbiological assay

Amphotericin B for peak identification

Ampicillin (anhydrous)

Ampicillin trihydrate

Amylmetacresol

Amylmetacresol for peak identification

Angelica dahuria root

Anhydrotetracycline hydrochloride

Antazoline hydrochloride

Apomorphine hydrochloride - Reference Spectrum

Apomorphine hydrochloride hemihydrate

Apomorphine impurity B (Morphine sulfate) (Morphinhemisulfat-Pentahemihydrat) Controlled Substance

Alpha-apo-oxytetracycline

Beta-apo-oxytetracycline

Aprotinin solution BRP

Aprotinin for system suitability

L-Arabinitol

Arbutin

Arginine

Arginine aspartate

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

60 mg

50 mg

20 mg

125 mg

20 mg

EPA0496020

EPA0575000

EPY0000129

EPY0000130

EPA0590000

EPA0590004

EPY0000563

EPY0000049

EPY0001067

EPY0001068

10 mg

100 mg

20 mg

20 mg

10 mg

10 mg

10 mg

150 mg

10 mg

10 mg

EPY0001069 10 mg

EPY0001070

EPY0000302

EPY0000303

EPA0650000

EPA0700000

EPA0800000

EPY0000005

EPY0001361

EPY0001014

EPA1000000

EPA1100000

EPY0001244

EPY0001245

EPY0001386

EPA1200000

EPA1210000

EPY0000172

EPY0001465

New EPY0001471

EPA1220000

EPA1230000

EPA1250000

EPY0001154

EPA1269000

EPY0000806

EPA1270000

EPY0000304

Edition 2012/2013

10 mg

unit

unit

500 mg

500 mg

100 mg

100 mg

100 mg

10 mg

250 mg

150 mg

285 mg

10 mg

160 mg

15 mg

50 mg

unit

15 mg

40 mg

20 mg

20 mg

0.5 mL

2.7 mg

10 mg

100 mg

50 mg

20 mg

253

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Table of content

European Pharmacopoeia

Code Product Unit

EPA1271000

New EPY0001323

EPY0001185

EPY0001175

EPY0000079

EPY0000080

EPY0000081

Arginine hydrochloride

Aristolochia

Aristolochic acid I

Aristolochic acid for system suitability

Articaine hydrochloride

Articaine impurity A methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate

Articaine impurity E methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl] amino]thiophene-2-carboxylate

Ascorbic acid (Vitamin C)

Ascorbic acid impurity C D-sorbosonic acid

Ascorbic acid impurity D methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate)

Ascorbyl palmitate

Asparagine monohydrate

Aspartame

Aspartame impurity A 2-(5-benzyl-3,6-dioxopiperazin-2-yl)acetic acid (diketopiperazine)

Aspartic acid

Astragaloside IV

Atenolol

Atenolol for system suitability

Atorvastatine calcium trihydrate

Atorvastatin impurity A desfluoroatorvastatin

Atorvastatin impurity B 3-epi-atorvastatin

Atorvastatin impurity C fluoroatorvastatin

Atorvastatin impurity D 3-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide

Atorvastatin impurity E ent-atorvastatin

Atracurium besilate

Atracurium for impurity F identification

Atracurium for peak identification

Atropine

Atropine for peak identification

Atropine impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate (noratropine)

Atropine sulphate

Azaperone

Azathioprine

Azathioprine impurity A 1-methyl-4-nitro-1H-imidazol-5-amine

Azathioprine impurity G 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine (thiamiprine)

Azelastine hydrochloride

Azelastine impurity B 1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane

Azelastine impurity D 4-(4-chlorobenzyl)phthalazin-1(2H)-one

Azelastine impurity E 3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one

50 mg

140 mg

1 mg

1 mg

100 mg

15 mg

10 mg

EPA1300000

EPY0001024

EPY0001170

EPY0000800

EPY0000305

EPA1320000

EPA1321000

EPA1330000

EPY0001171

EPA1340000

EPY0001089

EPY0001327

EPY0001328

EPY0001329

EPY0001330

EPY0001331

EPY0001332

EPY0000424

EPY0000503

EPY0000504

EPY0000878

EPY0000845

EPY0000816

EPA1400000

EPY0000029

EPA1500000

EPY0001240

EPY0001246

EPY0000326

EPY0000327

EPY0000328

EPY0000329

100 mg

20 mg

10 mg

10 mg

60 mg

40 mg

10 mg

50 mg

40 mg

100 mg

5 mg

150 mg

10 mg

10 mg

10 mg

10 mg

10 mg

120 mg

5 mg

5 mg

30 mg

0.25 mg

10 mg

50 mg

50 mg

100 mg

10 mg

5 mg

25 mg

5 mg

5 mg

5 mg

254 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 5: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000306

EPY0000637

EPY0000641

EPY0000307

EPY0000285

EPB0070000

EPB0100000

EPB0200000

EPB0200050

EPY0001273

EPB0250000

EPB0300000

EPY0000295

EPB0305000

EPY0000351

EPY0000352

EPY0000469

EPY0001073

EPY0001025

EPY0001038

EPY0001026

Azithromycin

Azithromycin for peak identification

Azithromycin for system suitability

Azithromycin impurity A 6-demethylazithromycin

B19 virus DNA for NAT testing BRP

Bacampicillin hydrochloride

Bacitracin zinc

Baclofen

Baclofen impurity A (RS)-4-amino-3-(4-chlorophenyl)butyric acid lactam

Baicalin

Bambuterol hydrochloride

Barbital Controlled Substance

Basic butylated methacrylate copolymer - Reference Spectrum

Beclometasone dipropionate anhydrous

Beclometasone dipropionate monohydrate

Beclometasone dipropionate for system suitability

Beclometasone dipropionate for peak identification

Beclometasone dipropionate impurities F and N

Benazepril hydrochloride

Benazepril for system suitability

Benazepril impurity A [(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-2,3,4,5-tetrahydro-1H-1- benzazepin-1-yl]acetic acid

Bendroflumethiazide

Bendroflumethiazide impurity A 4-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide

Benfluorex hydrochloride

Benfluorex hydrochloride for system suitability

Benperidol

Benserazide hydrochloride

Benserazide impurity A (RS)-2-amino-3-hydroxypropanohydrazide

Benserazide impurity C (2RS)-2-amino-3-hydroxy-2'-[(1EZ)-(2,3,4-trihydroxybenzylidene)]propanohydrazide

Benserazide for peak identification

Benzaldehyde

Benzalkonium chloride for system suitability

Benzarone (2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone

Benzathine benzylpenicillin

Benzbromarone

Benzethonium chloride

Benzocaine

Benzoic acid

Benzophenone

Benzyl alcohol

Benzyl benzoate - Reference Spectrum

S-Benzylmercaptoacetyltriglycin

Benzylpenicillin potassium

Benzylpenicillin sodium

Berberine chloride

200 mg

15 mg

0.05 mg

10 mg

150 mg

120 mg

150 mg

50 mg

50 mg

10 mg

100 mg

500 mg

unit

150 mg

10 mg

10 mg

10 mg

0.052 mg

160 mg

0.016 mg

10 mg

EPB0400000

EPY0000564

EPY0000044

EPY0000043

EPB0470000

EPB0477000

EPB0477010

EPY0001071

EPY0001079

EPY0001064

EPY0001060

EPB0490000

EPB0500000

EPY0000775

EPB0550000

EPB0600000

New EPY0001470

EPY0000647

EPY0000167

EPB0670000

EPB0680000

EPB0700000

EPB0900000

EPY0001149

100 mg

5 mg

50 mg

360 mg

100 mg

50 mg

20 mg

10 mg

10 mg

150 mg

20 mg

10 mg

125 mg

10 mg

100 mg

50 mg

30 mg

40 mg

50 mg

unit

10 mg

50 mg

200 mg

20 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 255

Page 6: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPB0950000

EPY0000391

EPB0990000

EPB1000000

EPB1030000

EPB1040000

New EPY0001416

New EPY0001418

EPB1045000

EPB1054000

EPB1055000

EPY0001027

EPY0001065

EPY0001360

EPB1103000

EPB1103100

EPY0001354

EPB1115000

New EPY0001444

New EPY0001448

EPY0001078

EPB1110000

New EPY0001421

EPB1110004

EPY0001059

EPB1116000

EPB1120000

EPB1121000

Betadex

Betahistine dihydrochloride

Betahistine mesilate

Betamethasone

Betamethasone acetate

Betamethasone diproprionate

Betamethasone dipropionate for peak identification

Betamethasone dipropionate for system suitability

Betamethasone sodium phosphate

Betamethasone-17-valerate

Betamethasone-21-valerate

Betamethasone valerate for system suitability

Betamethasone valerate impurity mixture

Betaxolol for peak identification

Betaxolol hydrochloride

Betaxolol impurity A (2RS)-1-(4-ethylphenoxy)-3-[(1-methylethyl)-amino]propan-2-ol

Betaxolol impurity C 2-[[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane

Bezafibrate

Bicalutamide

Bicalutamide for system suitability

Bicisate labelling kit

Bifonazole

Bifonazole for system suitability Bifonazole impurity B 4-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate

Bilberry dry extract

Biotin (Vitamin H)

Biperiden hydrochloride

Biperiden impurity A (1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl-3-(piperidin-1-yl)propan-1-ol (endo form)

Bisacodyl

Bisacodyl for peak identification

Bisacodyl for system suitability

Bisoprolol fumarate

Bisoprolol for peak identification Bisoprolol for system suitability method A CRS has been renamed as Bisoprolol for peak identification CRS

Bisoprolol for system suitability Bisoprolol for system suitability method B CRS has been renamed as Bisoprolol for system suitability CRS

Bleomycin sulfate

Boldine

Bordetella pertussis mouse antiserum BRP

Bromazepam Controlled Substance

Bromazepam for system suitability Controlled Substance

Bromhexine hydrochloride

Bromhexine impurity C N-(2-aminobenzyl)-N-methylcyclohexanamine

Bromocriptine mesilate

Bromocriptine mesilate for system suitability

Bromperidol

200 mg

50 mg

100 mg

75 mg

100 mg

150 mg

10 mg

10 mg

100 mg

100 mg

15 mg

25 mg

0.018 mg

15 mg

60 mg

10 mg

5 mg

100 mg

100 mg

15 mg

24 mg

100 mg

10 mg

10 mg

250 mg

20 mg

60 mg

20 mg

EPB1140000

EPY0000608

EPY0000694

EPY0000812

EPY0000877

50 mg

10 mg

5 mg

50 mg

1 mg

EPY0000813 1 mg

EPB1141000

EPY0000434

EPB1142000

EPB1143000

EPY0000645

EPB1145000

EPY0000200

EPB1150000

EPY0000677

EPB1152000

7 mg

30 mg

0.5 mg

60 mg

10 mg

100 mg

10 mg

30 mg

5 mg

100 mg

256 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 7: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPB1152050

EPB1153000

EPY0000468

EPY0000470

Bromperidol decanoate

Brompheniramine maleate

Brotizolam Controlled Substance

Brotizolam impurity B 2-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine (demethylbrotizolam)

Brucella melitensis Rev. 1 strain BRP

Budesonide

Budesonide for system suitability

Bufexamac

Buflomedil hydrochloride

Buflomedil impurity B 4-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one

Bumetanide

Bumetanide impurity A 3-nitro-4-phenoxy-5-sulphamoylbenzoic acid

Bumetanide impurity B 3-amino-4-phenoxy-5-sulphamoylbenzoic acid

Bupivacaine hydrochloride

Bupivacaine impurity B (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide

Bupivacaine impurity E 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide

Buprenorphine Controlled Substance

Buprenorphine hydrochloride Controlled Substance

Buprenorphine for system suitability Controlled Substance

Buserelin

D-His-Buserelin

Buspirone hydrochloride

Buspirone for system suitability

Busulfan

Butyl methanesulfonate

Butyl parahydroxybenzoate

Butyl parahydroxybenzoate impurity E 2-methylpropyl 4-hydroxybenzoate (iso-butyl parahydroxybenzoate)

Butylhydroxyanisole

Butylhydroxytoluene Plastic additive 07

Cabergoline

Caffeine

Caffeine for system suitability

Calcifediol

Calcifediol - Reference Spectrum

Calcipotriol (anhydrous) - Reference Spectrum

Calcipotriol monohydrate

Calcipotriol monohydrate - Reference Spectrum

Calcitonin (salmon)

Calcitonin-Gly

N-acetyl-cys1-calcitonin

Calcitriol

Calcitriol - Reference Spectrum

Calcium ascorbate - Reference Spectrum

Calcium folinate

Calcium glucoheptonate

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

60 mg

100 mg

10 mg

10 mg

EPB1155000

EPB1157300

EPY0001148

EPB1156000

EPB1157400

EPB1157410

EPB1158000

EPY0000309

EPY0000310

EPB1160000

EPY0000088

EPY0000089

EPY0001108

EPY0001109

EPY0001122

EPB1168000

EPB1168020

EPY0000131

EPY0000471

EPB1170000

EPY0001304

EPB1217000

EPY0001357

EPB1212000

EPB1215000

EPY0000472

EPC0100000

EPY0000787

EPC0166000

EPC0166001

EPY0000499

EPY0000473

EPY0000474

EPC0200000

EPY0000632

EPC0200010

EPC0225000

EPC0226000

EPC0249000

EPC0250000

EPC0299000

Edition 2012/2013

1 mL

110 mg

10 mg

100 mg

100 mg

20 mg

150 mg

5 mg

5 mg

100 mg

20 mg

20 mg

10 mg

10 mg

10 mg

2 mg

0.5 mg

5 mg

2 mg

50 mg

30 µl

100 mg

15 mg

50 mg

50 mg

100 mg

70 mg

20 mg

5 mg

unit

unit

5 mg

unit

2x0.98 mg

0.4 mL

20 mg

10 mg

unit

unit

100 mg

60 mg

257

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Table of content

European Pharmacopoeia

Code Product Unit

EPC0300000

EPC0340000

EPC0350000

EPC0400000

EPC0405000

EPY0001388

New EPY0001387

EPY0001389

EPC0410000

EPC0426000

EPY0000671

EPC0430000

EPY0001182

EPY0001219

EPY0001220

EPY0001221

EPY0000435

New EPY0001450

Calcium gluconate

Calcium levulinate dihydrate

Calcium oxalate monohydrate

Calcium pantothenate

Camphor (racemic)

Candesartan cilexetil

Candesartan cilexetil for peak identification

Candesartan cilexetil for system suitability

Canrenone

Caprylic acid

Capsaicin

Captopril

Captopril for system suitability Captopril impurity B (2S) 1-[(2S)-3-bromo-2-methylpropanoyl]pyrrolidine-2-carboxylic acid

Captopril impurity C (2RS)-2-methyl-3-sulphanylpropanoic acid

Captopril impurity D (2RS)-3-bromo-2-methylpropanoic acid

Captopril impurity E (2S)-1-isobutyryl-pyrrolidine-2-carboxylic acid

Captopril impurity J (2S)-1-[(2S)-3-(acetylsulfanyl)-2-methylpropanoyl]pyrrolidine-2-carboxylic acid (acetylcaptopril)

Carbachol

Carbamazepine

Carbamazepine impurity A 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide(10,11-dihydrocarbamazepine)

Carbasalate calcium - Reference Spectrum

Carbasalate impurity B 2-[[2-(acetyloxy)benzoyl]oxy]benzoic acid (acetylsalicylsalicylic acid)

Carbenicillin sodium

Carbidopa

Carbimazole

Carbocisteine

Carbon dioxide - Reference Spectrum

Carboplatin - Reference Spectrum

Carboprost trometamol

Carboprost trometamol - Reference Spectrum

Carisoprodol

Carisoprodol impurity A (2RS)-2-(hydroxymethyl)-2-methylpentyl(1-methylethyl)carbamate

Carmellose

Carmustine - Reference Spectrum

Carmustine impurity A 1,3-bis(2-chloroethyl)urea

Carprofen for veterinary use

Carprofen for system suitability

Carteolol hydrochloride - Reference Spectrum

Carteolol for system suitability

Carvedilol - Reference Spectrum

Carvedilol

Carvedilol for system suitability

Carvedilol impurity C (2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy) propan-2-ol

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

250 mg

500 mg

60 mg

50 mg

60 mg

10 mg

10 mg

50 mg

200 mg

50 mg

10 mg

20 mg

10 mg

10 mg

10 mg

10 mg

10 mg

EPY0000113

EPC0450000

EPY0000033

EPC0451000

EPY0001161

EPC0455000

EPC0460000

EPC0465000

EPC0470000

EPC0499900

EPC0550000

EPY0000475

EPY0000536

EPY0000035

EPY0000036

EPY0001214

EPC0580004

EPC0580010

EPY0000846

EPY0000884

EPY0000192

EPY0000193

EPY0000075

New EPY0001427

New EPY0001426

EPY0000103

50 mg

200 mg

10 mg

unit

5 mg

50 mg

50 mg

100 mg

60 mg

unit

unit

40 mg

unit

50 mg

10 mg

10 mg

unit

20 mg

30 mg

5 mg

unit

30 mg

unit

50 mg

10 mg

10 mg

258 Edition 2012/2013

Page 9: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPC0600000

EPC0630000

EPC0640000

EPC0650000

EPC0675000

EPC0682000

EPY0000505

EPC0682300

EPY0000240

EPC0682400

EPC0682410

Casein BRP

Cefaclor

Delta-3-Cefaclor

Cefadroxil

Cefalexin monohydrate

Cefalotin sodium

Cefalotin for impurity B identification

Cefamandole nafate

Cefapirin sodium

Cefatrizine propylene glycol

Cefatrizine impurity A 7-amino-(6R,7R)-3-[(2H-1,2,3-triazol-4-yl)sulfanyl]-methyl-8-oxo-5-thia-1- azabicyclo[4.2.O]oct-2-ene-2-carboxylic acid(7-ACA triazole)

Cefazolin

Cefepime dihydrochloride monohydrate

Cefepime dihydrochloride monohydrate for system suitability

Cefepime impurity E (6R,7R)-7-amino-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct- 2-ene-2-carboxylate

Cefixime

Cefoperazone dihydrate

Cefoperazone sodium - Reference Spectrum

Cefotaxime acid

Cefotaxime sodium

Cefotaxime for peak identification

Cefoxitin sodium

Cefpodoxime proxetil

Cefpodoxime proxetil for peak identification

Cefpodoxime proxetil for impurity H identification

Cefprozil

Cefprozil impurity A (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid (p-hydroxyphenylglycine)

Cefprozil for peak identification

Cefprozil impurity mixture

Cefradine

Cefradine for peak identification

Cefradine impurity mixture

Ceftazidime

Ceftazidime for peak identification

Ceftriaxone sodium

Ceftriaxone impurity A E-isomer

Cefuroxime axetil

Cefuroxime sodium

Celecoxib

Celecoxib impurity A 4-[5-(3-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide

Celecoxib impurity B 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide

Celiprolol hydrochloirde

Celiprolol impurity I 1-acetyl-1-(4-ethoxyphenyl)-3,3-diethylurea

Celiprolol for peak identification

Cellulose acetate

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 g

450 mg

20 mg

250 mg

150 mg

100 mg

10 mg

125 mg

100 mg

150 mg

60 mg

EPC0682800

EPY0000633

EPY0000634

EPY0001336

150 mg

150 mg

15 mg

10 mg

EPC0684000

EPC0684750

EPC0684800

EPY0000420

EPC0685000

EPY0000506

EPC0688000

EPY0001305

EPY0001306

EPY0001318

New EPY0001371

New EPY0001372

New EPY0001367

New EPY0001368

EPC0690000

EPY0000568

EPY0001174

EPC0690500

EPY0001111

EPC0691000

EPC0692000

EPC0694990

EPC0695000

New EPY0001445

New EPY0001446

New EPY0001447

EPY0000311

EPY0000312

EPY0000239

EPY0000784

Edition 2012/2013

200 mg

100 mg

unit

80 mg

30 mg

10 mg

100 mg

70 mg

10 mg

10 mg

120 mg

20 mg

10 mg

10 mg

300 mg

15 mg

0.04 mg

200 mg

10 mg

80 mg

10 mg

60 mg

150 mg

200 mg

10 mg

10 mg

10 mg

0.02 mg

20 mg

40 mg

259

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Table of content

European Pharmacopoeia

Code Product Unit

EPC0698005

EPY0001054

EPC0700000

EPC0980650

EPY0001197

EPC0980651

EPC0984100

EPC0990000

EPY0000073

EPY0000074

EPC1000000

EPC1050000

EPY0000104

EPC1100000

EPY0001298

EPY0001299

EPC1200000

EPC1300000

EPC1350000

EPC1400000

EPC1425000

EPC1435000

EPC1450000

EPC1500000

EPY0000476

EPC1510000

EPC1520000

EPC1540000

EPC1530000

EPY0000569

EPC2223030

EPC1650000

EPC1700000

EPC1800000

EPY0000436

EPY0000437

EPC1900000

EPY0000507

Cellulose acetate butyrate - Reference Spectrum

Cellulose acetate phthalate

Cephaeline hydrochloride

Cetirizine dihydrochloride

Cetirizine for peak identification

Cetirizine impurity A (RS)-1-[(4-chlorophenyl)phenylmethyl]piperazine

Cetostearyl isononanoate - Reference Spectrum

Cetyl alcohol

Cetyl palmitate 15

Cetyl palmitate 95

Cetylpyridinium chloride

Chenodeoxycholic acid

Chitosan hydrochloride

Chlorambucil

Chlorambucil for system suitability

Chlorambucil with impurity G

Chloramphenicol

Chloramphenicol dipalmitate

Chloramphenicol disodium disuccinate

Chloramphenicol palmitate isomer

Chloramphenicol sodium succinate

Chlorcyclizine hydrochloride

Chlordiazepoxide Controlled Substance

Chlordiazepoxide hydrochloride Controlled Substance

Chlordiazepoxide impurity A 7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide

Chlorhexidine

Chlorhexidine diacetate

Chlorhexidine dihydrochloride

Chlorhexidine for performance test

Chlorogenic acid

1-(4-Chlorophenyl)-1-phenylethanol Clemastine fumarate impurity C

Chloroquine sulphate

Chlorothiazide

Chlorphenamine maleate

Chlorphenamine impurity A 2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile

Chlorphenamine impurity C (3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine

Chlorpromazine hydrochloride

Chlorpromazine impurity A 3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine sulphoxide)

Chlorpromazine impurity D 3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine (demethylchlorpromazine)

Chlorpromazine impurity E 2-chloro-10H-phenothiazine

Chlorpromazine impurity F 3-(4-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine

Chlorpropamide

Chlorpropamide impurity B 1,3-Dipropylurea

unit

10 mg

15 mg

100 mg

1.01 mg

10 mg

unit

250 mg

60 mg

50 mg

20 mg

125 mg

30 mg

100 mg

10 mg

10 mg

500 mg

100 mg

25 mg

100 mg

1500 mg

100 mg

2x50 mg

100 mg

10 mg

50 mg

10 mg

50 mg

50 mg

20 mg

15 mg

200 mg

100 mg

100 mg

0.01 mg

10 mg

200 mg

10 mg

EPY0000479

New EPY0000508

EPY0001449

EPC1905000

EPC1905020

10 mg

10 mg

2 mg

100 mg

50 mg

260 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 11: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPC1915000

EPC1950000

EPY0000779

EPC2000000

EPY0001451

EPC2100000

EPC2150000

EPC2155000

EPC2158000

EPY0000280

EPY0000593

EPC2160000

EPY0000040

EPC2162701

EPC2162702

EPC2162700

EPC2163000

EPY0000361

EPC2170000

EPC2174000

EPC2174002

Chlorprothixene hydrochloride

Chlortalidone

Chlortalidone for peak identification

Chlortetracycline hydrochloride

Chlortetracycline for system suitability

Cholecalciferol

Cholecalciferol for system suitability

Cholesterol

Cholic acid

Chondroitin sulfate sodium

Chondroitin sulfate sodium (marine)

Chymotrypsin BRP

Ciclopirox

Ciclopirox impurity A (RS)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)acetic acid

Ciclopirox impurity B 6-cyclohexyl-4-methyl-2H-pyran-2-one

Ciclopirox olamine

Ciclosporin

Ciclosporin for system suitability

Cilastatin sodium

Cilazapril

Cilazapril impurity A 1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]- 10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate

Cilazapril impurity D (1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6H- pyridazino[1,2a][1,2]diazepine-1-carboxylic acid

Cimetidine

Cimetidine hydrochloride

Cimetidine for peak identification

Cimetidine for system suitability

Cinchocaine hydrochloride

Cineole

Cinnarizine

Ciprofibrate

Ciprofibrate for system suitability

Ciprofloxacin

Ciprofloxacin hydrochloride

Ciprofloxacin hydrochloride for peak identification

Ciprofloxacin impurity A 7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid (fluoroquinolonic acid)

Cisplatin

Cisplatin impurity A trans-diamminedichloroplatinium (II)

Cisplatin impurity B amminetrichloroplatinate (-)

Citalopram hydrobromide

Citalopram hydrochloride

Citalopram for system suitability

Citric acid (anhydrous)

Citric acid monohydrate

Cladribine

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg

150 mg

1.017 mg

100 mg

20 mg

500 mg

1 mL

100 mg

60 mg

250 mg

100 mg

100 mg

100 mg

20 mg

20 mg

150 mg

120 mg

5 mg

10 mg

50 mg

25 mg

EPC2174005 10 mg

EPC2175000

EPC2175500

EPY0001130

EPY0001146

EPC2177000

EPY0000176

EPC2180000

EPY0000362

EPY0000363

EPY0000198

EPC2190000

EPY0000199

EPC2190050

50 mg

100 mg

10 mg

0.5085 mg

60 mg

180 mg

100 mg

5 mg

5 mg

20 mg

100 mg

10 mg

10 mg

EPC2210000

EPY0001018

EPY0001019

EPY0001008

EPY0001007

EPY0000855

EPA1202000

EPC2219000

EPY0000639

Edition 2012/2013

100 mg

10 mg

10 mg

5 mg

5 mg

0.06 mg

50 mg

50 mg

50 mg

261

Page 12: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000609

EPY0000610

EPY0000320

EPY0000321

New EPY0001193

EPY0000269

EPC2221000

EPC2223000

EPC2248000

EPC2248010

EPC2250000

EPC2269000

EPY0000364

EPY0000205

EPY0000241

EPY0000559

EPY0000570

EPY0000571

Cladribine for peak identification

Cladribine impurity C 2-chloro-7H-purin-6-amine

Clarithromycin

Clarithromycin for peak identification

Clazuril

Clazuril for system suitability

Clebopride malate

Clemastine fumarate

Clenbuterol hydrochloride

Clenbuterol impurity B 1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone (clenbuterol ketone)

Clindamycin hydrochloride

Clindamycin phosphate

Clioquinol

Clobazam - Reference Spectrum

Clobazam impurity A 7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione

Clobetasol propionate

Clobetasol for peak identification

Clobetasol impurity J (17R)-4'-chloro-5'-ethyl-9-fluoro-11ß-hydroxy-16ß-methylspiro[androsta-1,4-diene- 17,2'(3'H)-furan]-3,3'-dione (17 alpha-spiro compound)

Clobetasone butyrate

Clobetasone butyrate for system suitability

Clodronate disodium tetrahydrate

Clodronate impurity D (chloromethylene)bis(phosphonic acid)

Clofazimine

Clofazimine for system suitability

Clofibrate

Clomifene citrate

Clomifene citrate for performance test

Clomipramine hydrochloride

Clomipramine impurity C 3-(3-chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine

Clomipramine impurity D 3-(3,7-dichloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl) N,N-dimethylpropan-1-amine

Clomipramine impurity F 3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine

Clonazepam Controlled Substance

Clonazepam - Reference Spectrum

Clonazepam impurity B 3-Amino-4-(2-chlorophenyl)-6-nitro-1H-quinolin-2-one

Clonidine hydrochloride

Clonidine impurity B 1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole

Clopamide

Clopamide for system suitability

Clopidogrel hydrogen sulfate

Clopidogrel for system suitability

Clopidogrel impurity A (2S)-(2-chlorophenyl)[6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetic acid

Closantel sodium dihydrate

10 mg

5 mg

160 mg

40 mg

10 mg

10 mg

100 mg

100 mg

30 mg

10 mg

200 mg

250 mg

5 mg

unit

10 mg

40 mg

2 mg

0.4 mg

EPC2285000

EPY0001137

EPY0000888

EPY0000885

EPY0000313

EPY0000358

EPC2300000

EPC2320000

EPC2332000

EPC2360000

EPY0000132

EPY0000133

50 mg

30 mg

5 mg

5 mg

150 mg

10 mg

0.5 mL

50 mg

50 mg

100 mg

10 mg

10 mg

EPY0000134

EPC2385000

EPY0000286

EPC2385015

EPC2400000

EPY0000801

EPY0000833

EPY0000848

EPY0001333

EPY0001334

EPY0001335

EPY0000392

5 mg

50 mg

unit

5 mg

100 mg

20 mg

40 mg

10 mg

60 mg

100 mg

10 mg

20 mg

262 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 13: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000393

EPC2424400

EPC2424550

EPC2424500

EPC2425600

EPC2430000

EPY0000818

EPY0000849

EPC2450000

EPC2460000

EPY0000758

New EPY0001472

EPY0000162

EPC2480000

EPY0000722

EPC2500000

EPY0000334

Closantel for system suitability

Clostridia (multi-component) rabbit antiserum (for vaccines-vet.use) BRP

Clostridium tetani guinea pig antiserum (for vaccines-human use) BRP

Clostridium tetani guinea pig antiserum (for vaccines - vet.use) BRP

Clostridium tetani rabbit antiserum (for vaccines - vet.use) BRP

Clotrimazole

Clotrimazole impurity E (2-chlorophenyl)phenylmethanone (2-chlorobenzophenone)

Clotrimazole for peak identification

Cloxacillin sodium

Clozapine

Clozapine for peak identification

Coagulation Factors V, VIII, XI and XIII plasma

Cocaine hydrochloride - Reference Spectrum

Cocoyl caprylocaprate

Codeine Controlled Substance

Codeine - Reference Spectrum

Codeine impurity A 7,8-didehydro-4,5α-epoxy-3,6α-dimethoxy-17-methylmorphinan (o-methylcodeine) Controlled Substance

Codeine hydrochloride dihydrate - Reference Spectrum

Codergocrine mesilate

Colchicine

Colchicine for system suitability

Colestyramine

Colistimethate sodium

Colistin sulfate

Colistin sulfate for microbiological assay

Copovidone - Reference Spectrum

Cortisone acetate

Coumarin

Cotton wool standard for neps

Crospovidone

Crotamiton

Crotamiton impurity A N-ethyl-N-(2-methylphenyl)but-3-enamide

Cyanidin chloride

Cyanocobalamin

Cyclizine hydrochloride

Cyclizine impurity A 1-methylpiperazine

Cyclizine impurity B diphenylmethanol (benzhydrol)

Cyclobenzaprine hydrochloride

Cyclopentolate hydrochloride

Cyclopentolate for system suitability

Cyclophosphamide

Cyproheptadine hydrochloride

Cyproheptadine impurity C 5-(1-methylpiperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5-ol

20 mg

1 mg

3x1 mg

1 mg

1 mg

100 mg

15 mg

1 mg

200 mg

60 mg

0.41 mg

2x1 mg

unit

40 mg

20 mg

unit

10 mg

EPC2500100

EPC2510000

EPC2580000

EPY0000209

EPY0000374

EPC2600000

EPY0000277

EPC2700000

EPC2725000

EPC2800000

EPY0000438

EPC2900000

EPY0001053

EPC2970000

EPC2970005

EPY0001061

EPC3000000

EPC3090000

EPY0000886

EPY0000887

EPC3200000

EPC3245000

EPY0001088

EPC3250000

EPC3280000

EPY0001095

unit

60 mg

15 mg

10 mg

10 mg

20 mg

25 mg

25 mg

unit

250 mg

80 mg

1000 mg

5 mg

100 mg

70 mg

20 mg

20 mg

50 mg

15 mg

10 mg

100 mg

2x50 mg

60 mg

50 mg

30 mg

5 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 263

Page 14: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPC3283000

EPY0001390

EPY0001223

EPC3290000

EPC3300000

EPC3350000

EPY0000733

EPY0000734

EPY0000735

EPD0070000

EPY0000600

EPD0100000

EPD0125000

EPD0120000

EPD0160000

EPD0201000

EPY0000611

EPD0300000

EPD0350000

EPY0000228

EPD0406200

EPD0430000

EPD0431000

EPY0001321

EPD0480000

EPY0000879

EPY0000807

EPD0500000

EPD0600000

EPD0630000

EPD0650000

EPY0000509

EPY0000510

EPD0400000

EPY0000001

EPD0660020

EPD0700000

EPY0001177

EPD0710000

EPY0001169

EPY0000538

EPY0000511

EPD0718000

EPD0720000

New EPY0001477

EPD0720800

Cyproterone acetate

Cyproterone acetate for peak identification

Cyproterone impurity mixture

Cysteine hydrochloride monohydrate

Cystine

Cytarabine

Dacarbazine

Dacarbazine impurity A 3,7-dihydro-4H-imidazo[4,5-d]-1,2,3-triazin-4-one (2-azahypoxanthine)

Dacarbazine impurity B 5-amino-1H-imidazole-carboxamide

Dalteparin sodium

Danaparoid sodium

Dapsone

Daunorubicin hydrochloride

Daunorubicinone Daunorubicin aglycone

Deferoxamine mesilate

Dehydrohexetidine 2-ethyl-N-[[1-(2-ethylhexyl)-4-methyl-4,5-dihydro-1H-imidazol-4-yl]methyl]hexan-1-amine

Dembrexine hydrochloride monohydrate

Demeclocycline hydrochloride

N-Demethylerythromycin A

Demethylflumazenil - Reference Spectrum

Deptropine citrate

Dequalinium chloride

Dequalinium chloride for performance test

Dermatan sulfate and oversulfated chondroitin sulfate

Desacetylvinblastine

Desflurance - Reference Spectrum

Desflurane impurity A 1,1'-oxybis(1,2,2,2-tetrafluoroethane)

Desipramine hydrochloride

Deslanoside

Desmethylmetrifonate

Desmopressin

Desogestrel

Desogestrel for system suitability

Desoxycortone acetate

Detomidine hydrochloride

Detomidine impurity B (RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol

Dexamethasone

Dexamethasone for system suitability

Dexamethasone acetate

Dexamethasone acetate impurity E 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregn-4-en-21-yl acetate

Dexamethasone isonicotinate

Dexamethasone isonicotinate for impurity C identification

Dexamethasone pivalate

Dexamethasone sodium phosphate

Dexamethasone sodium phosphate for peak identification

Dexchlorpheniramine maleate

30 mg

5 mg

0.01 mg

50 mg

100 mg

150 mg

20 mg

20 mg

10 mg

250 mg

10 mg

100 mg

100 mg

10 mg

30 mg

50 mg

10 mg

100 mg

10 mg

unit

60 mg

50 mg

50 mg

1 mL

2x1 mg

unit

1 mL

100 mg

150 mg

30 mg

0.98 mg

50 mg

10 mg

100 mg

100 mg

20 mg

50 mg

10 mg

100 mg

0.013 mg

10 mg

10 mg

50 mg

100 mg

10 mg

60 mg

264 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPD0730000

EPD0731000

EPD0731005

EPD0732000

EPD0733000

EPD0734000

EPD0735000

EPD0736000

EPD0737000

EPD0738000

EPD0739000

EPY0000744

EPD0740000

EPY0000261

EPY0001058

EPY0001150

EPD0940000

EPY0000596

EPD0950000

EPD0970000

EPD1000000

EPY0000480

EPY0000481

EPD1010000

EPY0000275

EPY0000259

EPY0000264

EPD1039990

EPS0765000

EPD1040000

EPD1050000

EPD1060000

EPY0000439

EPY0000440

EPY0000441

EPY0000442

Dexpanthenol

Dextran

Dextran 1

Dextran Vo

Dextran 4 for calibration

Dextran 10 for calibration

Dextran 40 for calibration

Dextran 70 for calibration

Dextran 250 for calibration

Dextran 40 for performance test

Dextran 60/70 for performance test

Dextranomer

Dextromethorphan hydrobromide

Dextromethorphan impurity A ent-3-methoxymorphinan

Dextropropoxyphene hydrochloride Controlled Substance

Dextropropoxyphene for system suitability Controlled Substance

Diazepam Controlled Substance

Diazepam for system suitability Controlled Substance

Diazoxide

Dibenzocycloheptene

Dibenzosuberone

Dibrompropamidine diisetionate

Dibrompropamidine for system suitability

Dibutyl phthalate

Dichlorodiaminocyclohexaneplatinum

Diclazuril for system suitability

Diclazuril for veterinary use - Reference Spectrum

Diclofenac potassium

Diclofenac sodium

Diclofenac impurity A 1-(2,6-dichlorophenyl)-indolin-2-one

Dicloxacillin sodium

Dicycloverine hydrochloride

Didanosine

Didanosine for system suitability

Didanosine impurity A 1,7-dihydro-6H-purin-6-one (hypoxanthine)

Didanosine impurity G 9-(2,3-dideoxy-β-D-glycero-pentofuranosyl)-9H-purin-6-amine (2',3'-dideoxyadenosine)

Dienestrol

Diethanolamine fusidate

Diethylcarbamazine citrate

Diethylene glycol (monoethyl ether) - Reference Spectrum

Diethyl phthalate

Diethylstilbestrol

Diethylstilbestrol dimethyl ether

Diethylstilbestrol monomethyl ether

Difloxacin hydrochloride

Difloxacin impurity G 7-chloro-6-fluoro-1-(4-fluorophenyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

Diflunisal

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg

25 mg

50 mg

10 mg

50 mg

50 mg

50 mg

50 mg

50 mg

50 mg

50 mg

50 mg

100 mg

5 mg

10 mg

5 mg

30 mg

0.5 mg

50 mg

20 mg

100 mg

10 mg

20 mg

1 mL

10 mg

20 mg

unit

100 mg

100 mg

0.005 mg

250 mg

100 mg

10 mg

10 mg

10 mg

10 mg

EPD1200000

EPD1250000

EPD1300000

EPY0000217

EPD1410000

EPD1500000

EPD1600000

EPD1700000

New EPY0001423

New EPY0001429

EPD1750000

Edition 2012/2013

150 mg

50 mg

250 mg

unit

1 mL

100 mg

10 mg

10 mg

60 mg

15 mg

30 mg

265

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Table of content

European Pharmacopoeia

Code Product Unit

EPD1800000

EPY0000640

EPD1900000

EPY0000554

EPD1940001

EPY0000232

EPY0000216

EPY0000053

EPD1945000

EPD1950000

EPY0000831

EPD1952000

EPD1954000

EPY0000544

EPY0000482

EPD1980000

New EPY0001439

Digitoxin

Digoxigenin

Digoxin

Digoxin for peak identification

Dihydralazine sulphate (hydrated) - Reference Spectrum

Dihydralazine for system suitability

Dihydrocodeine hydrogen tartrate - Reference Spectrum

17 alpha-dihydroequilin

Dihydroergocristine mesilate

Dihydroergotamine mesilate

Dihydroergotamine for peak identification

Dihydroergotamine tartrate

Dihydrostreptomycin sulfate (for LC assay)

Dihydrotachysterol

Dihydrotachysterol for system suitability

Diltiazem hydrochloride

Diltiazem impurity F (2S,3S)-5-[2-(dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5- benzothiazepin-4(5H)-one

Diltiazem for system suitability

Dimenhydrinate

N,N-Dimethylacetamide - Reference Spectrum

Dimenhydrinate for peak identification

Dimethyl sulfoxide

Dimeticone

Dimetindene maleate

Dinoprost trometamol

Dinoprostone

Dinoprostone impurity C (E)-7-[(1S,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxyoct-1-enyl]- 5-oxocyclopentyl]-hept-5-enoic acid (5-trans-PGE2;(5E)-PGE2)

Diosmin

Diosmin for system suitability

Diphenhydramine hydrochloride

Diphenhydramine impurity A 2-(diphenylmethoxy)-N-methylethanamine

Diphenoxylate hydrochloride - Reference Spectrum

Diphenoxylate hydrochloride Controlled Substance

Diphenoxylate for system suitability Controlled Substance

Diphtheria toxin BRP

Diphtheria vaccine (absorbed) BRP

Dipivefrine hydrochloride

Dipivefrine for system suitability

Dipotassium clorazepate - Reference Spectrum

Diprophylline

Dipyridamole

Dipyridamole for peak identification

Dirithromycin

Disodium edetate

Disopyramide

Disopyramide phosphate

Disulfiram

200 mg

5 mg

30 mg

10 mg

unit

10 mg

unit

10 mg

250 mg

100 mg

10 mg

150 mg

25 mg

30 mg

5 mg

300 mg

10 mg

EPY0001141

EPD2000000

EPY0000234

EPY0001103

EPD2050000

EPD2200000

EPD2205000

EPD2255000

EPD2250000

EPD2250015

10 mg

100 mg

unit

1 mg

1 mL

200 mg

50 mg

60 mg

100 mg

10 mg

EPY0000094

EPY0000095

EPD2600000

EPY0000135

EPD2630000

New EPY0001415

New EPY0001430

EPY0000258

EPD2700000

EPY0000376

EPY0000394

EPD2750100

EPD2800000

EPD2850000

EPY0000802

EPD2880000

EPD2900000

EPD2920000

EPD2922000

EPD2950000

70 mg

5 mg

100 mg

10 mg

unit

15 mg

10 mg

1 mL

32 mg

100 mg

10 mg

unit

100 mg

50 mg

2 mg

100 mg

100 mg

100 mg

100 mg

100 mg

266 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPD2953000

EPD2953025

EPD2953050

EPD2954000

EPY0001239

New EPY0001452

Dithranol

Dithranol impurity C Dithranol-dimer 4,4',5,5'-tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione

Dithranol impurity D 1-hydroxyanthracen-9(10H)-one

Dobutamine hydrochloride

Dobutamine impurity mixture

Docetaxel impurity E 5ß,20-epoxy-4-(acetyloxy)-1,7ß,10ß,13-tetrahydroxy-9-oxotax-11-en-2-yl benzoate (10-desacetyl-baccatin III)

Docetaxel trihydrate

Docetaxel for system suitability

Anhydrous Docetaxel

Docosahexaenoic acid ethyl ester

Docusate sodium - Reference Spectrum

Dodecyl gallate

Domperidone

Domperidone maleate

Dopamine hydrochloride

Dopexamine dihydrochloride

Dopexamine impurity B 2-methoxy-4-[2-[[6-[(2-phenylethyl)hexyl]amino]ethyl]phenol

Dopexamine impurity F 4-Chloro-5-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]benzene-1,2-diol

Dorzolamide hydrochloride

Dorzolamide impurity A (4R,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b] thiopyran-2-sulphonamide 7,7-dioxide

Dorzolamide for system suitability

Dosulepin hydrochloride

Dosulepin impurity A (E)-3-(6,11-dihydrodibenzo[b,e]thiepin-11-ylidene)- N,N'-dimethylpropan-1-amine S-oxide

Doubleteeth pubescent angelica root

Doxapram hydrochloride

Doxapram impurity B (4RS)-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenylpyrolidin-2-one

Doxazosin mesilate

Doxazosin impurity D 6,7-dimethoxyquinazoline-2,4(1H,3H)-dione

Doxazosin impurity F 2-chloro-6,7-dimethoxyquinazolin-4-amine

Doxepin hydrochloride

Doxepin for system suitability

Doxorubicin hydrochloride

Doxycycline hyclate

Doxylamine hydrogen succinate - Reference Spectrum

Doxylamine impurity A N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]ethanamine

Droperidol

Drospirenone

Drospirenone impurity E 3-oxo-6alpha,7alpha,15alpha,16alpha-tetrahydro-3'H,3''H-dicyclopropa [6,7:15,16]pregn-4-ene-21,17-carbolactone (17-epidrospirenone)

Duloxetine hydrochloride

Duloxetine for system suitability

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

55 mg

20 mg

20 mg

100 mg

0.1 mg

15 mg

EPY0001133

EPY0001155

New EPY0001466

EPD2954600

EPD2954500

EPY0000365

EPD2955000

EPD2957000

EPD2960000

EPY0000612

EPY0000613

EPY0000614

EPY0000726

EPY0000727

160 mg

10 mg

15 mg

150 mg

unit

30 mg

150 mg

150 mg

50 mg

10 mg

10 mg

10 mg

50 mg

5 mg

EPY0000750

EPD2962000

EPD2962005

5 mg

100 mg

50 mg

EPY0001385

EPD2963000

EPY0000208

EPY0000553

EPY0000551

EPY0000552

EPY0000838

EPY0000851

EPD2975000

EPD3000000

EPY0000163

EPY0000160

EPD3100000

EPY0001105

EPY0001115

500 mg

50 mg

10 mg

60 mg

10 mg

10 mg

5 mg

1 mg

150 mg

50 mg

unit

10 mg

150 mg

60 mg

0.06 mg

New EPY0001453

New EPY0001454

Edition 2012/2013

120 mg

40 mg

267

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0001455

EPY0001004

EPY0001005

EPY0001006

EPY0000249

EPY0000247

EPY0000248

EPY0001236

EPY0000254

EPE0050000

EPE0085000

EPY0000537

EPY0000512

EPE0100000

EPE0110000

EPE0109000

EPY0001211

EPY0000615

EPY0000629

EPY0000678

Duloxetine impurity A (3R)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine

Dydrogesterone

Dydrogesterone impurity A 9β,10-pregna-4,6,8(14)-triene-3,20-dione

Dydrogesterone impurity B pregna-4,6-diene-3,20-dione

Ebastine - Reference Spectrum

Ebastine impurity C 4-(diphenylmethoxy)piperidine

Ebastine impurity D 1-[4-(1,1-dimethylethyl)phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one

Econazole

Econazole for system suitability

Econazole nitrate

Eicosapentaenoic acid ethyl ester

Emedastine difumarate

Emedastine impurity E 1-(2-ethoxyethyl)-2-(hexahydro-1H-1,4-diazepin-1yl)benzimidazole

Emetine hydrochloride

Enalapril for system suitability

Enalapril maleate

Enalapril impurity mixture

Enalaprilat dihydrate

Enalaprilat for system suitability

Enalaprilat impurity G (2SR)-2-[(3SR,8aRS)-3-methyl-1,4-dioxohexahydropyrrolo [1,2-a]pyrazin-2(1H)-4-phenylbutanoic acid

Enilconazole

Enilconazole impurity E (1RS)-1-(2,4-dichlorophenyl)-2-(-1H-imidazol-1-yl)ethanol

Endotoxin standard BRP

Enoxaparin sodium

Enoxolone

Enrofloxacin

Enrofloxacin for system suitability

Entacapone

Entacapone impurity A Z isomer of entacapone

Enterokinase BRP

Ephedrine hydrochloride (racemic) Drug Precursor

Ephedrine hydrochloride Drug Precursor

4-Epianhydrotetracycline hydrochloride

4-Epidemeclocycline hydrochloride

6-Epidoxycycline hydrochloride

Epinastine hydrochloride

Epinastine hydrochloride for system suitability

4-Epioxytetracycline

Epirubicin hydrochloride

4-Epitetracycline hydrochloride

Equilin

Eq influenza Subtype 1 Strain A/eq/Newmarket/77 Horse Antiserum BRP

Eq influenza Subtype 2 American-like/Newmarket Horse Antiserum BRP

Eq Influenza Subtype 2 European-like/Newmarket Horse Antiserum BRP

10 mg

50 mg

6 mg

5 mg

unit

10 mg

10 mg

10 mg

20 mg

100 mg

200 mg

10 mg

10 mg

100 mg

20 mg

50 mg

0.06 mg

100 mg

10 mg

0.005 mg

EPY0000136

EPY0000137

EPE0150000

EPE0180000

EPE0180500

EPY0001259

EPY0001160

EPY0001249

EPY0001250

EPE0200000

EPE0305000

EPE0300000

EPE0400000

EPE0440000

EPE0500000

EPY0001139

EPY0001128

EPE0530000

EPE0550000

EPE0600000

EPY0000052

EPE0850010

EPE0850021

EPE0850022

60 mg

20 mg

10 mg

200 mg

100 mg

5 mg

10 mg

160 mg

10 mg

200 mg

50 mg

150 mg

20 mg

20 mg

50 mg

20 mg

10 mg

40 mg

100 mg

30 mg

15 mg

3x1 mg

3x1 mg

3x1 mg

268 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 19: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000712

New EPY0001325

EPE0900000

EPE1000000

EPE1100000

EPE1200000

EPY0000051

EPY0000177

EPE1300000

EPE1305000

EPE1310000

EPE1320000

EPE1400000

EPE1500000

EPE1500800

EPE1515000

EPY0000324

EPY0000338

EPY0001028

EPY0000749

EPE1600000

EPY0000852

EPY0000045

EPE1620000

EPY0000314

EPY0000046

EPE1680000

EPE1680005

EPE1700000

EPE1800000

EPY0001263

EPE1830000

EPE1840000

EPE1850000

EPY0000803

EPA1202800

EPE1860100

EPE1900000

EPY0001124

EPE2000000

EPE2150000

EPE2250000

EPE2195000

EPE2195900

EPE2202000

EPE2205500

EPY0000617

EPE2300000

EPE2400000

Edition 2012/2013

Eq Influenza Subtype 2 American-like/South Africa Horse Antiserum BRP

Equisetum palustre

Ergocalciferol

Ergometrine maleate Drug Precursor

Ergosterol

Ergotamine tartrate Drug Precursor

Erysipelas ELISA coating antigen BRP

Erythritol

Erythromycin for microbiological assay

Erythromycin A

Erythromycin B

Erythromycin C

Erythromycin estolate

Erythromycin ethylsuccinate

Erythromycin stearate

Erythropoietin BRP

Esketamine hydrochloride - Reference Spectrum

Esketamine impurity D (2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone ((R)-ketamine)

Esomeprazole magnesium trihydrate

Essential oil

Estradiol benzoate

Estradiol benzoate for system suitability

Estradiol butyrate

Estradiol hemihydrate

Estradiol for peak identification

Estradiol valerate

Estriol

Estriol impurity A 9,11-didehydroestriol

Estrone

Etacrynic acid

Etacrynic acid for system suitability

Etamsylate

Ethacridine lactate monohydrate

Ethambutol hydrochloride

Ethambutol for system suitability

Ethanol (anhydrous) - Reference Spectrum

Ethanol 96% - Reference Spectrum

Ethinylestradiol

Ethinylestradiol for system suitability

Ethionamide

Ethosuximide

Ethosuximide impurity A (2RS)-2-ethyl-2-methylbutanedioic acid

Ethyl acetate - Reference Spectrum

Ethylcellulose - Reference Spectrum

1-N-Ethylgaramin sulfate

1,1'-Ethylidenebistryptophan

Ethyl indole-3-carboxylate

Ethylmorphine hydrochloride - Reference Spectrum

Ethylnicotinamide

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

3x1 mg

200 mg

500 mg

50 mg

20 mg

100 mg

0.4 mg

1000 mg

250 mg

250 mg

50 mg

50 mg

100 mg

10 mg

50 mg

37.5 mg

unit

10 mg

10 mg

1000 mg

250 mg

10 mg

10 mg

100 mg

10 mg

50 mg

50 mg

20 mg

15 mg

100 mg

10 mg

30 mg

50 mg

250 mg

10 mg

unit

unit

200 mg

25.31 mg

100 mg

30 mg

30 mg

unit

unit

50 mg

2x0.00167 mg

10 mg

unit

150 mg

269

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Table of content

European Pharmacopoeia

Code Product Unit

EPE2425000

EPE2450000

EPE2451000

EPE2451010

EPY0000572

EPE2470000

EPE2470050

EPY0000768

EPE2499900

EPE2499901

EPE2499914

EPE2500000

EPE2503000

EPE2503004

EPE2600000

EPY0001365

EPE5000000

EPF0005000

EPY0000382

EPY0000409

EPY0000556

EPY0000660

EPY0000731

EPY0000732

EPF0030000

EPY0000415

EPF0040000

EPF0040010

EPF0040020

EPF0041000

EPF0048000

EPF0048005

EPF0048010

EPF0048035

Ethyl parahydroxybenzoate

Etifenin

Etilefrine hydrochloride

Etilefrine impurity A 2-ethylamino-1-(3-hydroxyphenyl)ethanone

Etidronate disodium

Etodolac

Etodolac impurity H 2-(7-ethylindol-3-yl)ethanol

Etodolac for peak identification

Etofenamate

Etofenamate for peak identification

Etofenamate impurity G 2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate

Etofylline

Etomidate

Etomidate impurity B methyl 1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate

Etoposide

Etoposide for system suitability

Eugenol

Famotidine

Famotidine for system suitability

Famotidine impurity D 3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide

Febantel

Febantel for system suitability

Felbinac

Felbinac impurity A 4-acetyl biphenyl

Felodipine

Felypressin

Fenbendazole

Fenbendazole impurity A methyl(1H-benzimidazol-2-yl)carbamate

Fenbendazole impurity B methyl[5(6)-chlorobenzimidazol-2-yl]carbamate

Fenbufen

Fenofibrate

Fenofibrate impurity A (4-chlorophenyl)(4-hydroxyphenyl)methanone

Fenofibrate impurity B 2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid)

Fenofibrate impurity G 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl] oxy]-2-methylpropanoate

Fenoterol for peak identification

Fenoterol hydrobromide

Fentanyl - Reference Spectrum

Fentanyl for system suitability Controlled Substance

Fentanyl citrate - Reference Spectrum

Fenticonazole nitrate

Fenticonazole impurity D (RS)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3- [4-(phenyl suphanyl)benzyl]imidazolium nitrate

150 mg

25 mg

75 mg

20 mg

10 mg

60 mg

10 mg

10 mg

40 mg

15 mg

20 mg

100 mg

50 mg

25 mg

150 mg

10 mg

500 µL

100 mg

10 mg

10 mg

110 mg

10 mg

10 mg

20 mg

120 mg

0.994 mg

150 mg

20 mg

20 mg

100 mg

100 mg

20 mg

10 mg

25 mg

EPY0000756

EPF0050000

EPF0054990

New EPY0001509

EPF0055000

EPF0060000

EPF0060040

1.2 mg

100 mg

unit

25 mg

unit

50 mg

20 mg

270 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 21: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPF0100000

EPY0001013

EPY0000789

EPY0000751

Ferrous gluconate

Ferulic acid

Fexofenadine hydrochloride

Fexofenadine impurity A 2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butanoyl]phenyl]-2-methylpropanoic acid

Fexofenadine impurity B 2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2- methylpropanoic acid

Fexofenadine impurity C (1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol

Filgrastim

Finasteride

Finasteride for system suitability

Flavoxate hydrochloride

Flavoxate impurity A 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid

Flavoxate impurity B ethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate

Flecainide acetate

Flecainide impurity A 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8a- hexahydroimidazo[1,5-a]pyridine

Flecainide impurity B (RS)-(piperidin-2-yl)methanamine

Flecainide for system suitability

Flubendazole

Flubendazole for system suitability

Flucloxacillin magnesium octahydrate

Flucloxacillin impurity C 6-aminopenicillanic acid

Flucloxacillin impurity D 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid

Flucloxacillin impurity E 6-aminopenicillanic acid flucloxacillin amide

Flucloxacillin sodium

Fluconazole

Fluconazole for peak identification

Fluconazole impurity B 2-[2-fluro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol

Fluconazole impurity C 1,1´-(1,3-phenylene)di-1H-1,2,4-triazole

Flucytosine

Flucytosine for system suitability

Fludarabine phosphate

Fludrocortisone acetate

Flumazenil - Reference Spectrum

Flumazenil impurity B ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylate

Flumequine

Flumequine impurity B ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j] quinolizine-2-carboxylate

Flumetasone pivalate

Flunarizine dihydrochloride

Flunarizine dihydrochloride - Reference Spectrum

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

20 mg

60 mg

5 mg

EPY0000752 0.01 mg

EPY0000753

EPY0001173

EPY0000090

EPY0000091

EPY0000736

EPY0000737

EPY0000738

EPF0120000

EPF0120005

5 mg

0.2 mL

60 mg

100 mg

10 mg

10 mg

10 mg

200 mg

50 mg

EPF0120010

EPY0001274

EPY0000138

EPY0000139

EPY0000892

EPY0000889

EPY0000890

EPY0000891

EPF0150000

EPY0000557

EPY0000558

EPY0000573

EPY0000574

EPF0175000

EPY0001262

EPY0000419

EPF0180000

EPF0188000

EPY0000335

25 mg

10 mg

25 mg

20 mg

5 mg

5 mg

5 mg

5 mg

250 mg

50 mg

10 mg

10 mg

5 mg

100 mg

10 mg

120 mg

100 mg

unit

5 mg

EPF0189000

EPF0189020

60 mg

0.1 mg

EPF0188500

EPF0189900

EPY0000265

Edition 2012/2013

100 mg

100 mg

unit

271

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000266

EPF0190000

EPY0000169

EPY0000443

EPY0000444

EPY0000445

EPF0200000

EPF0230000

EPY0000796

EPY0000804

EPY0000454

EPF0245000

EPF0250000

EPY0000762

EPY0000763

EPY0000764

EPY0000765

EPY0000791

EPF0253000

EPF0253020

EPF0253030

EPY0000064

EPY0000067

Flunarizine dihydrochloride for system suitability

Flunitrazepam Controlled Substance

Flunitrazepam - Reference Spectrum

Flunixin meglumine

Flunixin impurity B 2-methyl-3-(trifluoromethyl)aniline

Flunixin impurity C ethyl 2-chloropyridine-3-carboxylate

Fluocinolone acetonide

Fluocortolone pivalate

Fluorescein

Fluorescein impurity C 2-(2,4-dihydroxybenzoyl)benzoic acid

Diacetylfluorescein

Fluoresceine sodium - Reference Spectrum

Fluorouracil

Fluorouracil impurity A pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid)

Fluorouracil impurity B dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil)

Fluorouracil impurity C pyrimidine-2,4(1H,3H)-dione (uracil)

Fluorouracil impurity F 2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil)

Fluorouracil impurity mixture

Fluoxetine hydrochloride

Fluoxetine impurity B methyl(3-phenylpropyl)amine Controlled Substance

Fluoxetine impurity C (RS)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl]amine

Flupentixol dihydrochloride

Flupentixol impurity D 2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl] piperazin-1-yl]ethoxy]ethanol

Flupentixol impurity F 2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H-thioxanthen-9-yl)prop-2-enyl]- piperazin-1-yl]ethanol

Fluphenazine decanoate

Fluphenazine enantate

Fluphenazine dihydrochloride

Fluphenazine impurity mixture

Fluphenazine octanoate

Fluphenazine sulphoxide

Flurazepam monohydrochloride - Reference Spectrum

Flurbiprofen

Flurbiprofen impurity A (2RS)-2-(biphenyl-4-yl)propanoic acid

Fluspirilene

Fluspirilene impurity C 8-[4,4-bis((4-fluorophenyl)butyl]-3-(hydroxymethyl)-1- phenyl-1,3,8-triazaspiro[4.5]decan-4-one

Flutamide

Flutamide impurity C N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide

Fluticasone propionate

20 mg

100 mg

unit

10 mg

10 mg

50 mg

100 mg

100 mg

120 mg

0.01 mg

100 mg

unit

40 mg

10 mg

10 mg

10 mg

10 mg

0.0002 mg

250 mg

10 mg

5 mg

100 mg

15 mg

EPY0000078 25 mg

EPF0260000

EPY0000009

EPF0280000

EPY0000708

EPY0000298

EPY0000299

EPY0000211

EPF0285200

EPF0285202

EPY0000236

EPY0000375

60 mg

100 mg

50 mg

0.07 mg

20 mg

10 mg

unit

50 mg

20 mg

20 mg

10 mg

EPF0285600

EPF0285603

EPY0000284

50 mg

20 mg

100 mg

272 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000221 Fluticasone impurity D S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-androsta- 1,4-diene-17β-carbothioate (S-methyl derivative)

Flutrimazole

Flutrimazole impurity B (RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol

Fluvastatin sodium

Fluvastatin for system suitability

Fluvoxamine maleate

Fluvoxamine for system suitability

Fluvoxamine impurity D 5-methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one

Foeniculin for peak identification Anise oil

Folic acid

Folic acid impurity A (2S)-2-[(4-aminobenzoyl)amino]pentanedioic acid (N-(4-aminobenzoyl)-l-glutamic acid)

Folic acid impurity D 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic acid (pteroic acid)

Formoterol fumarate dihydrate

Formoterol for impurity I identification

Formoterol fumarate for system suitability

Formylfolic acid 10-Formylfolic acid

Foscarnet sodium hexahydrate

Foscarnet impurity B disodium(ethoxyoxydophosphanyl)formate

Foscarnet impurity D Ethyl (diethoxyphosphinyl)formate

Foscarnet impurity mixture

Fosfomycin calcium

Fosfomycin sodium - Reference Spectrum

Fosfomycin trometamol

Fosinopril sodium

Fosinopril impurity A (2S,4S)-4-cyclohexyl-1-[[(R)-hydroxy(4-phenylbutyl)phosphoryl] acetyl]pyrrolidine-2-carboxylic acid

Fosinopril impurity B (2RS,4RS)-4-cyclohexyl-1-[[(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

Fosinopril impurity C mixture of (2S,4S)-4-cyclohexyl-1-[[(S)-[(1S)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid and (2S,4S)-4-cyclohexyl-1-[[(R)- [(1R)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2- carboxylic acid

Fosinopril impurity D (2S,4R)-4-cyclohexyl-1-[[(R)-[(1S)-2-methyl- 1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

Fosinopril impurity I [(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetic acid

Fosinopril impurity K (2S,4S)-4-cyclohexyl-1-(2,2-dimethyl-1-oxopropyl) pyrrolidine-2-carboxylic acid

Fosinopril impurity mixture

Framycetin sulphate

Fructose

20 mg

EPF0290000

EPF0290010

EPY0001090

EPY0001082

EPY0000854

EPY0000853

EPY0000916

EPY0000386

EPF0300000

EPY0001242

100 mg

60 mg

110 mg

0.5 mg

5 mg

1.004 mg

10 mg

100 mg

2x150mg

15 mg

EPY0001243

EPF0372000

EPY0000339

EPY0000340

EPF0380000

EPF0389000

EPF0389004

EPY0001222

EPY0001213

EPY0000782

EPF0399950

EPF0400000

EPY0001227

EPY0001228

70 mg

10 mg

10 mg

10 mg

30 mg

50 mg

10 mg

50 mg

0.012 mg

10 mg

unit

1500 mg

60 mg

5 mg

EPY0001229 5 mg

EPY0001230 10 mg

EPY0001231 10 mg

EPY0001232 5 mg

EPY0001233 5 mg

EPY0001212

EPF0450000

EPF0550000

0.02 mg

2x25 mg

100 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 273

Page 24: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

New EPY0001399

New EPY0001413

EPF0600000

EPF0700000

New EPY0001493

EPF0702000

New EPY0001411

EPF1000000

New EPY0001394

New EPY0001384

EPY0001280

EPY0001281

EPY0001348

EPY0001349

EPG0049000

EPG0050000

EPY0001279

EPY0001190

EPY0001201

EPY0001191

EPG0100000

EPG0150000

EPY0001129

EPY0001144

EPY0000675

EPY0000676

EPY0000513

EPY0000514

EPG0200000

EPY0001363

EPY0001112

EPY0001110

EPY0001116

EPY0001012

EPY0001010

EPG0300000

EPG0325000

New EPY0001511

EPG0325010

EPY0000242

EPG0326000

EPG0326004

EPG0326012

EPY0000515

Fulvestrant

Fulvestrant for system sitability

Fumaric acid

Furosemide

Furosemide for peak identification

Furosemide impurity A 2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid

Fusidic acid

Fusidic acid - Reference Spectrum

Fusidic acid for peak identification

Fusidic acid impurity mixture

Gabapentin

Gabapentin impurity A 2-azaspiro[4.5]decan-3-one

Gabapentin impurity B (1-cyanocyclohexyl)acetic acid

Gabapentin impurity D [1-[(3-oxo-2-azaspiro[4.5]dec-2-yl)methyl]cyclohexyl]acetic acid

Galactitol

Galactose

Galantamine hydrobromide

Galantamine natural for system suitability

Galantamine racemic mixture

Galantamine synthetic for system suitability

Gallamine triethiodide

Gammacyclodextrin

Ganciclovir

Ganciclovir impurity mixture

Gemcitabine hydrochloride

Gemcitabine impurity A 4-aminopyrimidin-2(1H)-one (Cytosine)

Gemfibrozil

Gemfibrozil for system suitability

Gentamicin sulphate

Gentamicin for peak identification

Gestodene

Gestodene for system suitability

Gestodene impurity I 13-ethyl-17-hydroxy-5-methoxy-18,19-dinor-5alpha,17alpha-pregn-15-en-20-yn-3-one

Ginkgo dry extract for peak identification

Ginkgolic Acid

Gitoxin

Glibenclamide

Glibenclamide for peak identification

Glibenclamide impurity A 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide

Glibenclamide impurity B methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl] sulphonyl]carbamate

Gliclazide

Gliclazide impurity B 2-nitroso-octahydrocyclopenta[c]pyrrole

Gliclazide impurity F 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl-3-[(2-methylphenyl)sulphonyl]urea

Glimepiride

120 mg

40 mg

120 mg

100 mg

10 mg

5 mg

10 mg

unit

5 mg

0.0475 mg

300 mg

20 mg

20 mg

10 mg

50 mg

60 mg

10 mg

10 mg

10 mg

5 mg

100 mg

50 mg

220 mg

0.005 mg

50 mg

20 mg

5 mg

0.196 mg

2x25 mg

10 mg

100 mg

10 mg

0.01 mg

150 mg

20 mg

30 mg

100 mg

30 mg

10 mg

20 mg

20 mg

25 mg

50 mg

60 mg

274 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 25: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000516

EPG0340000

EPG0342000

EPY0000523

EPY0000643

EPY0001140

EPY0000191

New EPY0001406

New EPY0001381

New EPY0001407

EPG0350500

EPG0355000

EPY0000517

EPG0360000

EPG0400000

EPG0400004

New EPY0001391

EPY0000794

EPY0000795

EPG0400006

EPG0400007

EPG0400008

EPG0400101

EPG0400100

EPG0450000

EPY0001308

EPY0001309

EPY0001358

EPY0000433

EPG0460000

EPG0525000

EPY0000125

EPY0000126

New EPY0001473

EPY0000019

EPY0000194

EPG0550000

EPY0000396

EPY0000477

Glimepiride for system suitability

Glipizide

Glipizide impurity A 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide

Glipizide impurity C ethyl 2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl]carbamate

Glipizide impurity D 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide

Glipizide impurity mixture

Human glucagon

Glucosamine hydrochloride

Glucosamine for system suitability

Glucosamine sulfate sodium chloride

Glucose

Glutamic acid

Glutathione

Glutethimide Controlled Substance

Glycerol (85 per cent) - Reference Spectrum

Glycerol distearate

Glycerol formal

Glycerol monocaprylate

Glycerol monocaprylocaprate

Glycerol monolinoleate

Glycerol mono-oleate

Glycerol monostearate 40-55

Glyceryl trinitrate - Reference Spectrum

Glyceryl trinitrate solution

Glycine

Glycopyrronium bromide

Glycopyrronium for peak identification

Glycopyrronium impurity N (3RS)-3-[(2RS)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium

Ammonium glycyrrhizate

Glycyrrhizate (monoammonium)

Gonadorelin

Goserelin

Gosereline - Reference Spectrum

Goserelin for NMR identification

4-D-Ser-goserelin

Goserelin validation mixture

Gramicidin

Granisetron hydrochloride

Granisetron impurity A 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1] non-3-yl]-2H-indazole-3-carboxamide

Granisetron impurity B N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide

Granisetron impurity E (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-amine

Griseofulvin

Guaiacol

Guaifenesin

Halofantrine hydrochloride

0.012 mg

50 mg

10 mg

10 mg

10 mg

0.002 mg

2x2.94mg

10 mg

40 mg

15 mg

100 mg

50 mg

10 mg

50 mg

unit

2000 mg

2x20 mg

400 mg

500 mg

2000 mg

2000 mg

2000 mg

unit

0.5 mL

50 mg

10 mg

10 mg

10 mg

70 mg

300 mg

5 mg

2 mg

unit

14 mg

0.1 mg

1 mg

250 mg

120 mg

1 mg

EPY0000478

EPY0000395

EPG0600000

EPY0000619

EPG0700000

EPY0000117

1 mg

2x15 mg

50 mg

2200 mg

100 mg

125 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 275

Page 26: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000118

EPH0100000

New EPY0001517

New EPY0001518

EPH0100100

EPH0150000

EPY0000673

EPY0001287

EPY0001282

EPH0185000

EPH0190000

EPH0200000

EPY0001283

EPH0205010

EPY0001192

EPY0000389

EPH0210010

EPH0215000

EPH0220000

EPY0000063

EPY0000057

EPH0250000

EPH0330000

EPH0325000

EPH0400000

EPH0420000

EPH0500000

EPH0600000

EPH0700000

EPH0750000

EPH0755000

EPH0800000

EPH0830000

New EPY0001383

EPH0837000

EPH0900000

EPY0000219

EPY0000667

EPH0920000

EPH0920500

EPH0950000

EPH0990000

EPH1000000

EPY0000488

EPH1005000

EPH1100000

EPH1110000

EPY0000502

EPH1115000

Halofantrine impurity C [1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol

Haloperidol

Haloperidol for system suitability

Haloperidol for peak identification

Haloperidol decanoate

Halothane - Reference Spectrum

Harpagoside

Heparin calcium for NMR identification

Heparin for Physio-Chemical Analysis

Heparin Low-Molecular-Mass for assay BRP

Heparin Low-Molecular-Mass for calibration CRS

Heparin sodium BRP

Heparin sodium for NMR identification

Hepatitis A vaccine (inactivated,absorbed) Type B BRP

Hepatitis A Vaccine (Inactivated, Non-Adsorbed)

Hepatitis B vaccine (rDNA) BRP method A (thiomersal free)

Hepatitis B vaccine (rDNA) BRP method B

Hepatitis C Virus RNA for NAT testing BRP

Heptadecanol

Heptaminol hydrochloride

Heptaminol impurity A (2RS)-6-methylhept-5-en-2-amine

alpha-Hexachlorocyclohexane

Hexamidine diisetionate

Hexetidine

Hexobarbital

Hexylresorcinol

Hide Powder

Histamine dihydrochloride

Histamine phosphate

Histidine

Histidine hydrochloride monohydrate

Homatropine hydrobromide

Homatropine methylbromide

Homatropine methylbromide for system suitability

L-Homocycsteine thiolactone hydrochloride - Reference Spectrum

Human albumin for electrophoresis BRP

Human anti-D immunoglobulin BPR

Human coagulation factor VII concentrate BRP

Human coagulation factor VIII concentrate BRP

Human coagulation factor IX concentrate BRP

Human hepatisis A immunoglobulin BRP

Human immunoglobulin BRP

Human immunoglobulin for electrophoresis BRP

Human immunoglobulin (molecular size) BRP

Human Plasma Pools for NAT Validation

Human rabies immunoglobulin BRP

Human tetanus immunoglobulin BRP

Human vaccinia immunoglobulin

Hyaluronidase BRP

10 mg

50 mg

25 mg

25 mg

60 mg

unit

1.03 mg

30 mg

300 mg

5x1 mg

25 mg

2 mL

30 mg

3x0.5 mL

3x0.8 mL

2x0.5 mL

2x1 mL

5x40 mg

2x600 mg

150 mg

20 mg

10 mg

50 mg

100 mg

500 mg

100 mg

500 mg

250 mg

250 mg

100 mg

100 mg

100 mg

25 mg

5 mg

unit

1 mL

unit

2x26 mg

5x37 mg

5x30 mg

3x10 mg

15800 mg

96 mg

3x700 mg

3502 mg

3x170 mg

87 mg

3x1 mL

50 mg

276 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 27: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPH1120000

EPY0001151

EPH1200000

New EPY0001494

EPY0000646

EPY0000710

EPH1300000

EPY0001092

EPH1400000

New EPY0001482

EPH1425000

EPH1426000

EPY0000446

EPB0650000

EPH1428000

EPY0000119

EPH1429400

EPY0001322

EPY0001277

EPH1429700

EPH1430000

EPY0000186

EPH1435000

EPY0000011

EPY0000012

EPY0000013

EPY0000483

EPY0000484

Hydralazine hydrochloride

Hydrastine hyrochloride

Hydrochlorothiazide

Hydrochlorothiazide for peak identification

Hydrocodone hydrogen tartrate 2.5-hydrate Controlled Substance

Hydrocodone for peak identification Controlled Substance

Hydrocortisone

Hydrocortisone for peak identification

Hydrocortisone acetate

Hydrocortisone acetate for peak identification

Hydrocortisone hydrogen succinate

Hydrogenated wool fat

Hydromorphone hydrochloride Controlled Substance

Hydrous benzoyl peroxide - Reference Spectrum

Hydroxocobalamin

Hydroxycarbamide

Hydroxyethyl salicylate

Hydroxyethyl starch (high Mw)

Hydroxyethyl starch (medium MW)

4-Hydroxyphenoxymethylpenicillin potassium

D-alpha-(4-Hydroxy-phenyl)glycine (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid - Cefadroxyl impurity A

Hydroxypropylbetadex

Hydroxyzine hydrochloride

Hymecromone

Hymecromone impurity A Resorcinol

Hymecromone impurity B 7-hydroxy-2-methyl-4H-1-benzopyran-4-one

Hyoscine

Hyoscine impurity A (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2S)-3-hydroxy-2- phenylpropanoate (norhyoscine)

Hyoscine butylbromide

Hyoscine butylbromide impurity E (1R,2R,4S,5S,7S)-9-butyl-7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa- 9-azoni atricyclo[3.3.1.02,4]nonane

Hyoscine hydrobromide

Hyoscine hydrobromide impurity B (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)- 3-hydroxy-2-phenylpropanoate

Hyoscyamine sulfate

Hyoscyamine impurity E (1R,3s,5S)-8-azabicyclo[3.2.1] oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate

Hypromellose phthalate

Ibuprofen

Ibuprofen impurity B (2RS)-2-(4-Butylphenyl)propionic acid (0,06% solution in Acetonitrile)

Ibuprofen impurity F 3-[4-(2-methylpropyl)phenyl]propanoic acid

Ibuprofen for peak identification

Idoxuridine

Ifosfamide

Ifosfamide - Reference Spectrum

20 mg

20 mg

160 mg

10 mg

10 mg

10 mg

100 mg

5 mg

125 mg

15 mg

100 mg

250 mg

10 mg

unit

10 mg

175 mg

125 mg

800 mg

1200 mg

20 mg

50 mg

10 mg

600 mg

100 mg

25 mg

25 mg

10 mg

10 mg

EPH1450000

EPY0000447

20 mg

10 mg

EPH1500000

EPY0000448

50 mg

10 mg

EPH1600000

EPY0000449

EPY0000915

EPI0020000

EPB1220000

EPY0000140

EPY0000881

EPI0050000

EPI0060000

EPI0060100

100 mg

10 mg

10 mg

250 mg

1.15 mL

5 mg

0.09 mg

50 mg

50 mg

unit

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 277

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Table of content

European Pharmacopoeia

Code Product Unit

EPI0060002

EPI0060004

EPI0060010

EPI0060012

EPI0086000

EPI0090000

EPI0100000

EPY0000893

EPY0001153

EPY0000540

EPY0001205

EPI0150000

EPI0150020

EPY0000788

EPY0000880

EPY0000746

EPI0200000

EPY0000349

EPI0305000

EPI0310000

EPY0000348

EPI0320000

EPI0320300

EPI0320301

EPY0001101

EPI0320330

EPI0320331

EPI0328000

EPY0000839

EPY0001294

EPY0001292

Ifosfamide impurity A 3-[(2-chloroethyl)amino]propyl dihydrogen phosphate

Ifosfamide impurity B bis[3-[(2-chloroethyl)amino]propyl]dihydrogen diphosphate

Ifosfamide impurity E 3-chloro-N-(2-chloroethyl)propan-1-amine

Ifosfamide impurity F (RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide

Imidazole

Imipenem

Imipramine hydrochloride

Imipramine for system suitability

Immunoglobulin for anti-A, anti-B antibodies limit test

Immunoglobulin panel for anti-D antibodies test BRP

Imperatorin

Indapamide

Indapamide impurity B 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide

Indinavir

Indinavir sulfate - Reference Spectrum

Indinavir for system suitability

Indometacin

Insulin aspart

Insulin (bovine)

Insulin (human)

Insulin lispro

Insulin (porcine)

Interferon alfa-2a

Interferon alfa-2b

Interferon beta-1a

Interferon gamma 1b

Interferon gamma-1b validation solution

Iobenguane sulfate

Iobenguane sulphate - Reference Spectrum

Iodixanol

Iodixanol impurity C 5-[acetyl[3-[[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2- hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

Iodixanol impurity E 5-[acetyl[3-[acetyl[3-carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodobenzene-1,3-dicarboxamide

Iodixanol impurity H 5-[acetyl[3-[acetyl[3-[[3-[3-[acetyl[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropoxy]-2-hydroxypropyl]carbamoyl]-5-[(2,3- dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3- dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

Iohexol

Iohexol impurity A 5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide

Iohexol impurity J 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3-dicarboxamide

Iohexol for peak identification

Iopamidol

Iopamidol impurity A N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethy]-5-amino-2,4,6-tri-iodoisophthalamide

2x100 mg

20 mg

2x10 mg

10 mg

100 mg

100 mg

50 mg

10 mg

45 mg

unit

20 mg

150 mg

5 mg

100 mg

unit

20 mg

50 mg

8 mg

7.99 mg

8 mg

5.93 mg

8.61mg

1 mL

200 µL

0.5 mL

2x0.5 mL

0.2 mL

25 mg

unit

60 mg

10 mg

EPY0001291 10 mg

EPY0001293 10 mg

EPI0320800

EPI0320810

EPI0320820

EPY0000672

EPI0329000

EPI0329010

150 mg

50 mg

125 mg

10 mg

50 mg

10 mg

278 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000406 Iopamidol impurity H 4-chloro-N,N'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5- (2-hydroxypropanoyl)amino)2,6-diiodobenzenz-1,3-dicarboxamide

Iopanoic acid

Iopentol

Iopromide

Iopromide impurity A 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methylbenzene-1,3- dicarboxamide

Iopromide for system suitability 1

Iopromide for system suitability 2

Iotalamic acid

Iotalamic acid impurity A 5-Amino-2,4,6-tri-iodo-N-methylisophthalamic acid

Iotrolan

Iotrolan for system suitability

Ioxaglic acid

Ioxaglic acid impurity A 3-amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic acid

Ipratropium bromide

Ipratropium impurity A (1R,3r,5S,8r)-3-hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane

Ipratropium bromide impurity B (1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1-methylethyl)-8- azoniabicyclo[3.2.1]octane

Irbesartan

Irbesartan impurity A 1-(pentylamino)-N-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]cyclopentanecarboxamide

Isoconazole

Isoconazole nitrate

Isoemetine hydrobromide

Isoflurane

Isoflurane - Reference Spectrum

Isoleucine

Isomalt

Isomaltooligosaccharide

Isoniazid

Isoprenaline hydrochloride

Isoprenaline sulfate

Isopropyl hexadecanoate

Isopropyl tetradecanoate

Isosorbide dinitrate

Isosorbide mononitrate

Isosorbide-2-nitrate

Isotretinoin

Isotretinoin for peak identification

Isoxsuprine hydrochloride

Isradipine

Isradipine impurity D methyl 1-methylethyl 4-(2,1,3-benzoxadiazol-4-yl)-2,6-dimethylpyridine-3,5-dicarboxylate

Itraconazole

Itraconazole for system suitability

Ivermectin

Ivy leaf standardised tincture

Josamycin

10 mg

EPI0330000

EPY0001297

EPY0001020

EPY0001077

EPY0001021

EPY0001022

EPI0340000

EPA0560000

EPY0000555

EPY0000658

EPY0000141

EPY0000142

EPI0360000

EPY0000276

EPI0361000

100 mg

10 mg

100 mg

0.125 mg

5 mg

5 mg

150 mg

20 mg

100 mg

5 mg

125 mg

20 mg

120 mg

10 mg

10 mg

EPY0001166

EPY0001156

EPI0375000

EPI0380000

EPI0400000

EPY0000858

EPY0000037

EPI0460000

EPI0465000

EPY0000070

EPI0500000

EPI0599990

EPI0600000

EPI0725000

EPI0750000

EPI0775000

EPI0775010

EPI0775020

EPI0800000

New EPY0001218

EPI0900000

EPY0000366

EPY0000367

EPI7000000

EPY0001100

EPI8000010

EPY0000575

EPY0000041

60 mg

10 mg

200 mg

200 mg

25 mg

1.5 mL

unit

50 mg

3000 mg

0.9 mg

100 mg

50 mg

500 mg

100 mg

2 mL

300 mg

100 mg

50 mg

60 mg

10 mg

50 mg

125 mg

5 mg

150 mg

15 mg

150 mg

2 mL

150 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 279

Page 30: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000042

EPY0001315

EPK0100000

EPK0200000

EPY0000450

EPK0551000

EPY0000246

EPY0000244

EPY0000245

EPK0600000

EPK1000000

EPK2000000

EPK2000010

EPK2000015

EPY0000486

EPY0000626

EPY0000164

EPY0000161

New EPY0001200

EPL0050000

EPL0129000

EPY0000257

EPA1206000

EPL0100000

EPL0130000

EPY0000188

EPY0000425

EPY0000518

EPY0000426

EPY0001030

EPY0001031

EPY0001085

EPY0001032

EPY0000773

EPY0000774

New EPY0001474

EPY0000654

EPY0000487

EPY0000674

EPY0000685

EPL0375000

EPL0376000

EPL0376001

EPY0000047

EPL0380000

EPY0000048

Josamycin propionate

Josamycin for peak identification

Kanamycin B sulfate

Kanamycin monosulfate

Ketamine hydrochloride Controlled Substance

Ketamine impurity A 1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol

Ketobemidone hydrochloride - Reference Spectrum

Ketobemidone impurity B B 1-[4-(3-hydroxyphenyl)-1-methylpiperidin-4-yl]ethanone

Ketobemidone impurity C 1-[4-(3-hydroxyphenyl)piperidin-4-yl]propan-1-one

Ketoconazole

3-Ketofusidic acid

Ketoprofen

Ketoprofen impurity A 1-(3-benzoylphenyl)ethanone

Ketoprofen impurity C 3-[(1RS)-1-carboxyethyl]benzoic acid

Ketorolac trometamol

Ketorolac trometamol for peak identification

Ketotifen hydrogen fumarate - Reference Spectrum

Ketotifen impurity G 4-(1-methylpiperidin-4-ylidene)-4H-benzo(4,5)cyclohepta(1,2-b)thiophen-9,10-dione

Kudzuvine root dry extract

Labetalol hydrochloride

Lactitol monohydrate

Lactobionic acid

Lactose (anhydrous)

Lactose

Lactulose

Lactulose for system suitability

Lamivudine

Lamivudine for system suitability 1

Lamivudine for system suitability 2

Lamotrigine

Lamotrigine for peak identification

Lamotrigine for system suitability

Lamotrigine impurity E 2,3-dichlorobenzoic acid

Lansoprazole

Lansoprazole for peak identification

Lauric acid

Leflunomide

Leflunomide impurity A 4-(trifluoromethyl)aniline

Leflunomide for peak identification

Letrozole

Leucine

Leuprorelin

Leuprorelin - Reference Spectrum

Levamisole hydrochloride for system suitability

Levamisole hydrochloride

Levamisole - Reference Spectrum

150 mg

25 mg

20 mg

150 mg

10 mg

50 mg

unit

5 mg

5 mg

150 mg

10 mg

50 mg

10 mg

5 mg

10 mg

5 mg

unit

0.0225 mg

200 mg

80 mg

60 mg

100 mg

100 mg

100 mg

3000 mg

12 mg

150 mg

10 mg

10.3 mg

10 mg

20 mg

10 mg

10 mg

60 mg

1 mg

1500 mg

100 mg

25 mg

1 mg

70 mg

50 mg

1 mg

unit

60 mg

50 mg

unit

280 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 31: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0001253

EPY0001254

EPY0001255

EPY0001256

EPY0001257

EPL0390000

EPL0390008

Levetiracetam

Levetiracetam impurity A (2RS)-2-(2-oxopyrrolidin-1-yl)butanoic acid

Levetiracetam impurity B (2Z)-2-(2-oxopyrrolidin-1-yl)but-2-enamide

Levetiracetam impurity C pyridin-2-ol

Levetiracetam impurity D (2R)-2-(2-oxopyrrolidin-1-yl)butanamide ((R)-etiracetam)

Levocabastine hydrochloride

Levocabastine impurity D 1-[cis-4-cyano-4-(4-fluorophenyl)cyclohexyl]-

4-phenylpiperidine-4-carboxylic acid

Levocarnitine

Levocarnitine impurity A (E)-or(Z)-4-(trimethylammonio)but-2-enoate

Levodopa

Levodropropizine

Levodropropizine impurity A (2R)-3-(4-phenylpiperazin-1-yl)propane-1,2-diol(dextrodropropizine)

Levodropropizine impurity B 1-phenylpiperazine

Levodropropizine impurity C 2,3-epoxypropan-1-ol

Levomepromazine hydrochloride

Levomepromazine maleate

Levonorgestrel

Levonorgestrel impurity B 13-ethyl-17-hydroxy-18,19-dinor-17-alpha-pregn-5(10)-en-20-yn-3-one

Levonorgestrel for system suitability

Levothyroxine for peak identification

Levothyroxine sodium

Lidocaine

Lidocaine hydrochloride

Lincomycin chlorhydrate for system suitability

Lincomycin hydrochloride

Liothyronine sodium

Liothyronine for peak identification

Lisinopril for system suitability

Lisinopril dihydrate

Lisinopril impurity F (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-cyclohexylpropyl]amino]hexanoyl]pyrrolidine- 2-carboxylic acid (cyclohexyl analogue)

Lithium clavulanate

Lithocholic acid

Lobeline hydrochloride

Lomustine

Loperamide hydrochloride

Loperamide hydrochloride for system suitability

Loperamide oxide monohydrate

Lopinavir for system suitability

Loratadine

Loratadine for system suitability

110 mg

10 mg

10 mg

10 mg

10 mg

125 mg

20 mg

EPL0399900

EPL0399905

EPL0400000

EPL0420000

EPL0420002

EPY0001033

EPY0001048

EPL0500000

EPL0505000

EPL0551000

New EPY0001379

New EPY0001431

New EPY0001382

EPL0570000

EPL0595000

EPL0600000

New EPY0001393

EPL0650000

EPL0700000

EPY0000860

EPY0001235

EPL0702000

EPY0001234

125 mg

50 mg

100 mg

60 mg

20 mg

50 mg

300 mg

100 mg

50 mg

30 mg

10 mg

10 mg

10 mg

100 mg

50 mg

100 mg

10 mg

250 mg

50 mg

0.0046 mg

2 mg

50 mg

0.01 mg

EPL0720000

EPL0720800

EPY0000112

EPL0745000

EPL0750000

EPY0000322

EPY0000341

New EPY0001505

EPY0000688

EPY0000603

125 mg

60 mg

50 mg

50 mg

50 mg

15 mg

20 mg

10 mg

60 mg

20 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 281

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000604 Loratadine impurity F ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta [1,2-b]pyridin-11-yl]piperidine-1-carboxylate

Loratadine impurity H ethyl 4-oxopiperidine-1-carboxylate

Lorazepam Controlled Substance

Lorazepam for system suitability Controlled Substance

Lorazepam impurity D (5RS)-7-chloro-5-(2-chlorophenyl)-4,5-dihydro-1H- 1,4-benzodiazepine-2,3-dione

Losartan potassium

Losartan impurity D 2-butyl-4-chloro-1H-imidazole-5-carbaldehyde

Losartan for system suitability

Lovastatin

Lovastatine for peak identification

Lufenuron

Lufenuron for peak identification

Lufenuron impurity G 2,5-dichloro-4-[[[(2,6-difluorophenyl)carbonyl]carbamoyl] amino]phenyl phenyl carbonate

Lynestrenol

Lynestrenol for peak identification

Lysine acetate

Lysine hydrochloride

Macrogol 30 dipolyhydroxystearate

Macrogol 40 sorbitol heptaoleate

Macrogol polyvinyl alcohol grafted polymer

Magnesium aspartate dihydrate

Magnolol

Malathion

Malathion impurity A diethyl(2RS)-2-[(methoxy)(methylsulfanyl)-S-phosphinothioyl] butane dioate

Malathion impurity B diethyl(2RS)-2-(dimethoxy-S-phosphinothioyl)-butanedioate

Maleic acid

Malic acid - Reference Spectrum

Maltitol

Mannitol

Maprotiline hydrochloride

Maprotiline impurity D 3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine

Marbofloxacin

Marbofloxacin for peak identification

Measles vaccine (live) BRP

Mebendazole

Mebendazole for system suitability

Mebendazole - Reference Spectrum

Mebrofenin

Meclozine dihydrochloride

Meclozine impurity B 4-chlorobenzhydrol

Meclozine impurity H 1-(4-chlorobenzhydryl)piperazine

10 mg

EPY0000605

EPL0750500

EPY0000576

EPY0000718

50 mg

100 mg

0.8 mg

10 mg

EPY0001062

EPY0001072

EPY0001076

EPL0790000

EPY0001136

EPY0001284

EPY0001261

EPY0001265

50 mg

6 mg

0.0015 mg

60 mg

20 mg

140 mg

0.4028 mg

15 mg

EPL0800000

EPY0001034

EPY0000397

EPL0900000

EPY0001369

EPY0000745

EPY0001157

EPM0088000

New EPY0001289

EPM0120000

EPM0120005

50 mg

20 mg

60 mg

50 mg

100 mg

20 mg

400 mg

60 mg

20 mg

250 mg

10 mg

EPM0120010

EPM0100000

EPY0000143

EPM0160000

EPM0200000

EPM0206000

EPM0206040

EPY0000819

EPY0000820

EPM0210000

EPM0215000

EPY0000144

EPY0000168

EPY0001086

EPM0220000

EPY0001310

EPY0001311

10 mg

100 mg

unit

1200 mg

1200 mg

100 mg

25 mg

10 mg

20 mg

5 uc

20 mg

20 mg

unit

120 mg

150 mg

15 mg

15 mg

282 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 33: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPM0240000

EPY0001107

EPY0001106

EPM0250000

EPM0250010

EPY0000598

EPM0252600

EPY0001081

EPM0253000

EPM0260100

New EPY0001524

New EPY0001507

EPY0001209

EPY0001080

EPY0001035

EPY0001036

EPY0001037

Medronic acid

Medronic acid impurity A Tris(1-methylethoxy)phosphane

Medronic acid impurity B Tetrakis(1-methylethyl)methhylenediphosphonate

Medroxyprogesterone acetate

Medroxyprogesterone acetate for performance test

Medroxyprogesterone acetate for system suitability

Mefenamic acid

Mefenamic acid impurity A 2,3-dimethylaniline

Mefloquine hydrochloride

Megestrol acetate - Reference Spectrum

Megestrol acetate for system suitability

Megestrol acetate for peak identification

Meglumine

Meloxicam

Meloxicam impurity A ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide

Meloxicam impurity B 5-methylthiazol-2-amine

Meloxicam impurity C N-[(2Z)-3,5-dimethylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide

Meloxicam impurity D N-[(2Z)-3-ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide

Melphalan - Reference Spectrum

Melphalan for system suitability

Melphalan hydrochloride

Menadione

Menthol

Mepivacaine hydrochloride

Mepivacaine impurity B (RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide

Meprobamate Controlled Substance

Mepyramine maleate

Mepyramine impurity A N-(4-methoxybenzyl)pyridin-2-amine

Mepyramine impurity C pyridin-2-amine

Meropenem trihydrate

Mesalazine

Mesityl oxid

Mesna - Reference Spectrum

Mesna impurity C 2-(Acetylsulphanyl)ethanesulphonic acid

Mesna impurity D 2,2'-(disulphanediyl)bis(ethanesulphonic acid)

Meso-rich exametazime

Mesterolone

Mesterolone impurity A 17β-hydroxy-1alpha-methylandrost-4-en-3-one

Mestranol

Metacresol - Reference Spectrum

Metacycline hydrochloride

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

20 mg

60 µl

40 µl

100 mg

50 mg

10 mg

50 mg

100 mg

100 mg

unit

50 mg

25 mg

10 mg

50 mg

5 mg

5 mg

5 mg

EPY0001039 5 mg

New EPY0001513

New EPY0001457

New EPY0001158

EPM0300000

EPM0350000

EPM0370000

EPM0370020

EPM0400000

EPM0500000

EPY0000679

EPY0000680

EPY0001252

EPY0000297

EPY0001040

EPY0000337

EPY0000316

EPY0000317

EPY0000227

EPY0000097

EPY0000096

EPM0600000

EPY0000301

EPM0600500

Edition 2012/2013

unit

10 mg

100 mg

100 mg

150 mg

100 mg

60 mg

100 mg

1000 mg

10 mg

10 mg

110 mg

125 mg

100 mg

unit

10 mg

10 mg

0.5 mg

60 mg

30 mg

100 mg

unit

50 mg

283

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Table of content

European Pharmacopoeia

Code Product Unit

EPM0600900

EPM0600905

New EPY0001481

EPM0605000

EPY0000770

EPY0000323

EPM0610000

EPM0610030

EPM0620000

EPM0630000

EPM0800000

EPY0000428

EPM0900000

EPY0000754

EPM0950000

EPM0960000

EPM1000000

EPY0000602

EPY0000663

Metamizole sodium

Metamizole impurity A 4-formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one

Metamizole impurity E 4-N-Demethylanalgin

Metformin hydrochloride

Methacrylic acid-ethylacrylate copolymer (1:1) - type A

Methacrylic acid-ethyl acrylate copolymer (1:1) - type B

Methacrylic acid-ethylacrylate copolymer (1:1) - Reference Spectrum

Methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30% - Reference Spectrum

Methacrylic acid-methylmethacrylate copolymer (1:1) - Reference Spectrum

Methacrylic acid-methylmethacrylate copolymer (1:2) - Reference Spectrum

Methadone hydrochloride - Reference Spectrum

Methanol - Reference Spectrum

Methaqualone - Reference Spectrum

Methenamine

DL-Methionine

Methionine

Methotrexate

Methotrexate for peak identification

Methotrexate impurity C (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6- yl)methyl]methylamino]benzoyl]amino]pentanedioic acid (N-methylfolic acid, methopteridine)

Methotrexate impurity D 4-[[(2-amino-4hydroxypteridin-6-yl)methyl]methyl-amino]benzoic acid

Methotrexate impurity E 4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoic acid (4-amino-N10-methylpteroic acid, APA)

Methylatropine bromide

Methylatropine nitrate

Methylcarbidopa

Methyl 2-(4-chlorophenoxy)-2-methylpropionate

Methyldopa

Racemic methyldopa

Methyldopa for system suitability

Methylene chloride

2-(1-Methylethyl)pentanoic acid

Methyl 12-hydroxystearate

Methyl nicotinate

Methylergometrine maleate

Methylergometrine for system suitability

Methylnitrosoindoline

Methyl parahydroxybenzoate

Methylphenidate hydrochloride Controlled Substance

Methylphenidate impurity mixture

Methylphenobarbital Controlled Substance

Methylprednisolone

Methylprednisolone acetate

Methylprednisolone hydrogen succinate

Methylprednisolone hydrogen succinate for performance test

2-Methylpyrazine

N-Methylpyrrolidone - Reference Spectrum

100 mg

15 mg

15 mg

50 mg

200 mg

200 mg

unit

unit

unit

unit

unit

unit

unit

10 mg

50 mg

50 mg

100 mg

20 mg

10 mg

EPM1000008

EPY0000664

10 mg

10 mg

EPM1300000

EPM1400000

EPM1450000

EPM1470000

EPM1500000

EPY0001374

EPY0001083

EPM1550000

EPM1551000

EPM1556000

EPY0000398

EPY0000776

EPY0000777

EPM1625000

EPM1650000

EPY0001017

EPY0000910

EPM1700000

EPM1750000

EPM1755000

EPM1755200

EPM1755220

New EPY0001376

EPY0000190

100 mg

100 mg

1 mg

0.5 mL

50 mg

5 mg

0.024 mg

2 mL

25 mg

100 mg

25 mg

10 mg

0.53 mg

110 mg

150 mg

40 mg

0.04 mg

500 mg

150 mg

100 mg

125 mg

50 mg

100 mg

unit

284 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPM1770180

EPY0000418

EPY0000407

EPM1770200

EPM1800000

EPY0000861

EPM1800900

EPM1800902

EPM1808000

EPM1824990

EPM1825000

EPM1824995

EPM1825010

EPY0000701

EPY0000702

EPY0000171

EPM1830000

EPY0000145

EPM1845000

EPM1850000

EPM1851000

EPY0000069

EPY0000087

EPM1860000

EPY0000202

EPY0000203

EPM1875000

EPY0001041

Methyl ricinoleate

Methylrosanilinium chloride

Methylrosanilinium chloride for system suitability

Methyl stearate

Methyltestosterone

Methyltestosterone for system suitability

Methylthioninium chloride

Methylthioninium impurity A 3-(dimethylamino)-7-(methylamino)phenothiazin-5-ylium

Metixene hydrochloride

Metoclopramid

Metoclopramide hydrochloride

Metoclopramide impurity A 4-(acetylamino)-5-chloro-N-(2-diethylaminoethyl)-2-methoxy benzamide

Metoclopramide impurity E N,N-diethylethane-1,2-diamine

Metolazone

Metolazone for system suitability

Metoprolol succinate - Reference Spectrum

Metoprolol tartrate

Metoprolol impurity A (2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol

Metrifonate

Metronidazole

Metronidazole benzoate

Metronidazole benzoate - Reference Spectrum

Metronidazole impurity A 2-methyl-4-nitroimidazole

Mexiletine hydrochloride

Mexiletine impurity C 1,1'-[(3,3',5,5'-tetramethylbiphenyl-4,4'-diyl)bisoxy]dipropan-2-amine

Mexiletine impurity D (2RS)-2-(2,6-dimethylphenoxy)propan-1-amine

Mianserin hydrochloride

Mianserin impurity B (14bRS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f] pyrazino[1,2-a]azepine-8-sulfonic acid

Mianserin hydrochloride for system suitability

Miconazole

Miconazole nitrate

Midazolam Controlled Substance

Midazolam impurity C acide 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylique

Midazolam for system suitability Controlled Substance

Milk thistle standardised dry extract

Minocycline hydrochloride

Minoxidil

Minoxidil for system suitability

Mirtazapine

Mirtazapine for system suitability

Misoprostol

Misoprostol for system suitability

Mitomycin

125 mg

40 mg

10 mg

100 mg

100 mg

10 mg

50 mg

20 mg

75 mg

100 mg

50 mg

25 mg

20 mg

80 mg

10 mg

unit

60 mg

10 mg

100 mg

50 mg

50 mg

unit

10 mg

100 mg

2 mg

2 mg

100 mg

10 mg

EPY0000862

EPM1880000

EPM1900000

EPM2200000

EPY0000562

1.01 mg

70 mg

100 mg

50 mg

0.08 mg

EPY0000599

EPY0000539

EPM2280000

EPM2300000

New EPY0001432

EPY0000705

EPY0000721

EPY0000490

EPY0001162

EPY0000378

1 mg

120 mg

125 mg

50 mg

10 mg

10 mg

10 mg

60 mg

5 mg

120 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 285

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Table of content

European Pharmacopoeia

Code Product Unit

EPM2305000

EPM2305005

EPY0000635

EPY0000636

EPY0000251

EPY0000821

EPY0000822

EPY0000823

EPM2900000

New EPY0001436

New EPY0001435

New EPY0001433

New EPY0001434

EPY0000028

EPY0000451

EPY0000452

EPY0000830

EPY0000772

EPY0000747

EPY0000703

EPY0000717

EPY0000226

EPY0000222

EPM3600000

EPM3805000

EPM3805500

EPM3806000

EPY0000489

EPY0000519

EPY0000692

EPY0000690

EPY0000691

EPY0000689

EPY0000485

New EPY0001484

EPN0020000

EPN0020020

EPN0020030

EPY0000146

EPY0001215

EPN0025000

EPY0000077

EPY0000120

EPY0000121

Mitoxantrone hydrochloride

Mitoxantrone impurity A 1-amino-5,8-dihydroxy-4-[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthracene-9,10-dione

Modafinil

Modafinil for system suitability

Molgramostim

Molsidomine

Molsidomine impurity B N-Nitrosomorpholine

Molsidomine impurity D morpholine-4-carbaldehyde

Mometasone furoate

Montelukast dicyclohexylamine

Montelukast for peak identification

Montelukast racemate

Montelukast sodium

Morantel hydrogen tartrate

Morphine hydrochloride (trihydrate) Controlled Substance

Morphine sulphate Controlled Substance

Morphine for system suitability Controlled Substance

Moxidectin

Moxidectin for system suitability

Moxifloxacin hydrochloride

Moxifloxacin for peak identification

Moxonidine

Moxonidine impurity A 4,6-dichloro-N-(imidazolidin-2-ylidene)-2-methylpyrimidin-5-amine

Mumps vaccine (live) BRP

Mupirocin - Reference Spectrum

Mupirocin calcium - Reference Spectrum

Mupirocin lithium

Mycophenolate mofetil

Mycophenolate mofetil for peak identification

Mycoplasma fermentans BRP

Mycoplasma hyorhinis BRP

Mycoplasma orale BRP

Mycoplasma synoviae BRP

Myo-inositol

Medroxyprogesterone acetate for peak identification

Nabumetone

Nabumetone impurity D (E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one

Nabumetone impurity F 6,6'-dimethoxy-2,2'-binaphthalenyl

Nadolol

Nadolol impurity mixture

Nadroparin calcium

Naftidrofuryl - Reference Spectrum

Naftidrofuryl impurity A 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoic acid

Naftidrofuryl impurity B ethyl 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoate

50 mg

5 mg

110 mg

0.1 mg

0.3 mL

5 mg

10 mg

10 mg

100 mg

150 mg

20 mg

20 mg

150 mg

50 mg

25 mg

40 mg

15 mg

70 mg

10 mg

110 mg

10 mg

50 mg

10 mg

5x33 mg

unit

unit

100 mg

30 mg

10 mg

1 mL

1 mL

1 mL

1 mL

1020 mg

25 mg

60 mg

10 mg

10 mg

100 mg

0.01 mg

250 mg

unit

10 mg

25 mg

286 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000331 Naftidrofuryl impurity F 2-[(diethylamino)ethyl 2-[(naphthalen-2-yl)methyl]-3- (tetrahydrofuran-2-yl)propanoate

Nalidixic acid

Naloxone hydrochloride dihydrate

Naloxone for peak identification

Naltrexone hydrochloride

Naltrexone impurity C N-(3-butenyl)-noroxymorphone

Nandrolone decanoate

Nandrolone decanoate for peak identification

Nandrolone decanoate for system suitability

Naphazoline hydrochloride

Naphazoline nitrate

Naphazoline impurity A N-(2-aminoethyl)-2-(naphthalen-1-yl)acetamide (Naphthylacetylethylenediamine)

Naproxen

Naproxen (racemic)

Naproxen impurity L 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)

Naringin

Nateglinide

Nateglinide impurity A trans-4-(1-methylethyl)cyclohexanecarboxylic acid

Nateglinide impurity B N-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-Lphenylalanine (L-phenylalanine isomer)

Nateglinide impurity C N-[[cis-4-(1-methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (cis-isomer)

Neamine

Neohesperidin dihydrochalcone

Neohesperidin dihydrochalcone impurity B 7-[[2-O-(6-deoxy-α-L-mannopyranosyl)-ß-D-glucopyranosyl]oxy]-5-hydroxy-2- (3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one (neodiosmin)

Neomycin sulfate

Neomycin sulphate for microbiological assay

Neostigmine bromide

Neostigmine metilsulfate

Netilmicin sulphate

Nevirapine (anhydrous)

Nevirapine hemihydrate

Nevirapine for peak identification

Newcastle Disease Vaccine (inacativated) BRP

Nicergoline - Reference Spectrum

Nicergoline

Nicergoline for peak identification

Nicergoline for system suitability

Nicergoline impurity A [(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl- 4,6,6a,7,8,9,10,10a-octahydroindol [4,3-fg]quinolin-9-yl]methyl 5-chloropyridine-3-carboxylate

Nicergoline impurity D 5-bromopyridine-3-carboxylic acid

Niclosamide (anhydrous)

Nicotinamide

Nicotine - Reference Spectrum

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

10 mg

EPN0050000

EPN0075000

EPY0000695

EPY0000400

EPY0000410

EPY0000542

EPY0000547

EPY0000548

EPN0080000

EPN0100000

EPN0200000

EPN0250000

EPY0000399

EPY0000631

New EPY0001378

New EPY0001437

New EPY0001440

New EPY0001441

100 mg

100 mg

10 mg

50 mg

15 mg

5 mg

10 mg

10 mg

50 mg

10 mg

10 mg

100 mg

10 mg

10 mg

20 mg

200 mg

10 mg

15 mg

New EPY0001442

EPN0300000

EPN0399000

EPN0399004

10 mg

0.5 mg

125 mg

10 mg

EPN0400000

EPN0401000

EPN0500000

EPN0550000

EPN0559000

EPY0000520

New EPY0001499

EPY0000521

EPY0000388

EPY0000287

EPY0001373

EPY0001362

EPY0001352

EPY0000283

50 mg

25 mg

50 mg

50 mg

2x25 mg

30 mg

15 mg

0.058 mg

4 uc

unit

50 mg

1 mg

10 mg

10 mg

EPY0001356

EPN0560000

EPN0600000

EPN0590000

Edition 2012/2013

20 mg

50 mg

50 mg

unit

287

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Table of content

European Pharmacopoeia

Code Product Unit

EPN0590200

New EPY0001425

EPY0001023

EPN0700000

EPY0001268

EPN0750000

EPN0750010

EPN0750015

EPY0000824

EPY0000825

EPY0000826

EPY0000827

EPY0000836

EPN0800000

EPY0000829

EPY0000894

EPN0845000

EPN0845008

EPY0001237

EPN0850000

EPN0850010

Nicotine ditartrate

Nicotine ditartrate dihydrate

Nicotine for system suitability

Nicotinic acid

Nicotinic acid impurity mixture

Nifedipine

Nifedipine impurity A Dimethyl 2,6-dimethyl-4-(2-nitrophenyl) pyridine-3,5-dicarboxylate

Nifedipine impurity B Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl) pyridine-3,5-dicarboxylate

Niflumic acid

Niflumic acid impurity A 2-chloropyridine-3-carboxylic acid

Niflumic acid impurity B 2-hydroxy-N-(3-(trifluoromethyl)phenyl)pyridine-3-carboxamide

Niflumic acid impurity E 6-((3-(trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid

Nifuroxazide

Nikethamide

Nilutamide

Nilutamide impurity B 4-nitro-3-(trifluoromethyl)aniline

Nimesulide

Nimesulide impurity D 4-nitro-2-phenoxyaniline

Nimesulide for peak identification

Nimodipine

Nimodipine impurity A 2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate

Nitrazepam Controlled Substance

Nitrazepam impurity A 3-amino-6-nitro-4-phenylquinol-2-one

Nitrendipine

Nitrendipine for peak identification

Nitrendipine impurity A ethyl methyl-2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate; (nitrophenylpyridine analogue)

Nitric oxide - Reference Spectrum

Nitrofural

Nitrofural for peak identification

Nitrosotriaminopyrimidine

Nizatidine

Nizatidine for system suitability

Nizatidine impurity F (EZ)N1,N1-[thiazole-2,4-diylbis(methylenesulphanediylethylene)] bis(N’-methyl-2-nitroethene-1,1-diamine)

Nomegestrol acetate

Nomegestrol acetate impurity A 6-alpha-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate

1-nonadecanol

Nonivamide

Nonoxinol 9

Noradrenaline tartrate

120 mg

15 mg

1 mg

100 mg

0.12 mg

50 mg

20 mg

20 mg

10 mg

10 mg

10 mg

15 mg

10 mg

1 mL

110 mg

5 mg

100 mg

0.004 mg

10 mg

50 mg

1 mL

EPN0900000

EPN0900010

EPN0905000

New EPY0001456

EPN0905005

100 mg

25 mg

60 mg

10 mg

30 mg

EPN0930000

EPN0950000

EPY0001377

EPN1000000

EPN1090000

New EPY0001278

EPN1090060

unit

100 mg

0.11 mg

50 mg

250 mg

10 mg

10 mg

EPN1080000

EPN1080005

EPY0001314

EPY0000670

EPY0000755

EPN1100000

100 mg

50 mg

400 mg

10 mg

10 mg

200 mg

288 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000681 Noradrenaline impurity D 4[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (Noradrenaline methyl ether)

Noradrenaline impurity E 2-chloro-1-(3,4-dihydroxyphenyl)ethanone

Noradrenaline impurity F N-benzyl-1-phenylmethanamine

Norcyclobenzaprine

Nordazepam Controlled Substance Dipotassium clorazepate impurity B

Norethisterone

Norethisterone acetate

Norethistherone for system suitability

Norfloxacin

Norfloxacin for peak identification

Norfloxacin impurity A 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

Norfloxacin for system suitability

Norgestimate

Norgestimate for system suitability

Norgestrel

Norpseudoephedrine hydrochloride Controlled Substance

Nortriptyline for system suitability

Nortriptyline hydrochloride

Noscapine

Nystatin

Octoxinol 10

Octyl gallate

Octyldodecanol

Ofloxacin

Ofloxacin impurity A (RS)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de][1,4]benzoxazine-6-carboxylic acid (FPA)

Ofloxacin impurity E (RS)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de] [1,4]benzoxazine-6-carboxylic acid

Olanzapine

Olanzapine for system sitability

Olanzapine impurity A 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile

Oleic acid

Oleuropein

Olmesartan medoxomil

Olmesartan medoxomil for system suitability

Olsalazine sodium

Olsalazine sodium for performance test

Omeprazole

Omeprazole magnesium

Omeprazole for peak identification

Omeprazole impurity D Omeprazole sulphone

Ondansetron hydrochloride dihydrate

Ondansetron for LC system suitability

Ondansetron for TLC system suitability

15 mg

EPY0000682

EPY0000686

EPN1130000

EPN1140000

EPN1200000

EPN1225000

EPY0000522

EPN1230000

EPY0001301

EPN1230010

EPY0001015

EPY0000724

EPY0000725

EPN1250000

EPN1279000

EPY0001296

EPN1280000

EPN1300000

EPN1400000

EPO0100900

EPY0000368

EPO0101000

EPO0120000

EPO0120010

10 mg

10 mg

25 mg

50 mg

100 mg

100 mg

10 mg

50 mg

10 mg

20 mg

8 mg

10 mg

5 mg

30 mg

50 mg

20 mg

10 mg

100 mg

100 mg

300 mg

30 mg

400 mg

50 mg

20 mg

EPO0120050 20 mg

New EPY0001370

New EPY0001380

New EPY0001392

New EPY0001479

EPY0000805

New EPY0001405

New EPY0001424

EPO0146000

EPO0146010

EPO0150000

EPY0001043

EPY0001042

EPO0151000

EPY0000218

EPY0000197

EPY0000196

200 mg

10 mg

5 mg

2000 mg

20 mg

100 mg

10 mg

60 mg

60 mg

50 mg

10 mg

10 mg

10 mg

200 mg

10 mg

30 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 289

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0001345 Ondansetron impurity A (3RS)-3-[(dimethylamino)methyl]-9-methyl-1,2,3,9- tetrahydro-4H-carbazol-4-one

Ondansetron impurity D 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one

Ondansetron impurity E Imidazole

Ondansetron impurity F

Ondansetron impurity G (3RS)-3-[(1H-imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro- 4H-carbazol-4-one (C-demethylondansetron)

Orbifloxacin

Orbifloxacin impurity mixture

Orciprenaline sulfate

Orciprenaline for system suitability

Orphenadrine citrate

Orphenadrine hydrochloride

Orphenadrine for peak identification

Orphenadrine impurity E (RS)-N,N-dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamine (meta-methylbenzyl isomer)

Oseltamivir phosphate impurity B free

Oseltamivir impurity A (3R,4R,5S)-5-acetamido-4-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid

Oseltamivir impurity B ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3- (1-ethylpropoxy)cyclohexanecarboxylate

Oseltamivir impurity C (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid

Oseltamivir impurity H tributylphosphane oxide

Osthole

Ouabain

Oxacillin sodium monohydrate

Oxacillin for peak identification

Oxaliplatin

Oxaliplatin impurity C (OC-6-33)-[(1R,2R)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)- kO¹,kO²]dihydroxyplatinum

Oxaliplatin impurity D (SP-4-2)-[(1S,2S)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)- kO¹,kO² ]platinum (S,S-enantiomer of oxaliplatin)

Oxazepam Controlled Substance

Oxazepam for peak identification

Oxeladin hydrogen citrate

Oxeladin impurity C 2-(diethylamino)ethyl 2-ethyl-2-phenylbutanoate

Oxeladin impurity D 2-(2-diethylaminoethoxy)ethyl 2-phenyl-butyrate dihydrogen citrate

Oxfendazole for veterinary use

Oxfendazole impurity B methyl[5-(phenylsulphonyl)-1H-benzimidazole-2-yl]carbamate

Oxfendazole with impurity D

Oxitropium bromide Oxitropium bromide impurity B (1R,2R,4S,5S,7s)-7-[[(2S)-3-hydroxy-2-phenylpropanoyl)oxy]-9,9-dimethyl-3-oxa-9- azoniatricyclo[3.3.1.02,4]nonane (methylhyoscine)

10 mg

EPY0000195

EPY0001326

EPY0001320

EPY0001346

10 mg

10 mg

10 mg

10 mg

EPY0001125

EPY0001147

EPO0180000

EPY0000895

EPY0000101

EPY0000100

EPY0001181

EPY0000102

200 mg

0.0008 mg

100 mg

5 mg

100 mg

100 mg

0.42 mg

30 mg

EPY0001337

EPY0001338

EPY0001339

300 mg

10 mg

10 mg

EPY0001340

EPY0001341

EPY0001207

EPO0200000

EPY0000638

EPY0000560

EPY0000271

EPY0000273

10 mg

30 mg

20 mg

150 mg

110 mg

10 mg

250 mg

25 mg

EPY0000274 10 mg

EPO0225000

EPY0000543

EPY0000350

EPY0000404

EPY0000390

EPO0225800

EPY0000224

EPY0000225

EPY0000709

EPY0000715

50 mg

0.008 mg

50 mg

10 mg

20 mg

50 mg

10 mg

10 mg

50 mg

15 mg

290 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 41: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000713 Oxitropium bromide impurity D (1R,2R,4S,5S,7s,9r)-9-ethyl-9-methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-9- azoniatricyclo[3.3.1.02,4]nonane (apo-N-ethylhyoscine)

Oxolinic acid

Oxolinic acid impurity A 8-hydroxy-1,3-dioxolo[4,5-g]quinoline-7-carboxylic acid

Oxolinic acid impurity B ethyl 5-ethyl-8-oxo-5,8-dihydro-1,3-dioxolo[4,5-g]quinoline-7-carboxylate

Oxprenolol hydrochloride

Oxibendazole

Oxybuprocaine hydrochloride

Oxybutynin hydrochloride

Oxybutynin impurity A 4-(diethylamino)but-2-ynyl(RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate

Oxycodone hydrochloride Controlled Substance

Oxycodone impurity D 7,8-didehydro-4,5 alpha-epoxy-14-hydroxy-3-methoxy-17- methylmorphinan-6-one (14-hydroxycodeinone)

Oxymetazoline hydrochloride

Oxymetazoline impurity A N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide

Oxytetracycline

Oxytetracycline hydrochloride

Oxytocin

Oxytocin/Desmopressin validation mixture about 0.1 mg oxytocin + 0.1 mg desmopressin per vial

Paclitaxel

Paclitaxel impurity C N-debenzoyl-N-hexanoylpaclitaxel

Paclitaxel natural for peak identification

Paclitaxel semi-synthetic for peak identification

Paclitaxel semi-synthetic for system suitability

Palmitic acid

Pamidronate disodium pentahydrate

Pancrease powder (amylse and lipase) BRP

Pancreas powder (protease) BRP

Pancuronium bromide Vecuronium impurity B

Pancuronium bromide for system suitability

Pantoprazole sodium sesquihydrate

Pantoprazole for system suitability

Papaverine hydrochloride

Paracetamol

Paraffin (hard)

Paraffin (liquid) - Reference Spectrum

Paraffin (White soft)

Paraffin (Yellow soft)

Parnaparin sodium

Paroxetine hydrochloride (anhydrous)

Paroxetine hydrochloride hemihydrate

Paroxetine impurity A (3S,4R)-3-[[1,3-benzodioxol-5-yloxy]methyl]-4-phenylpiperidine (desfluoroparoxetine)

Paroxetine hydrochloride (anhydrous) impurity C (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine (N-benzylparoxetine)

10 mg

EPO0240000

EPO0240005

EPO0240010

EPO0250000

EPO0260000

EPO0270000

EPO0288000

EPO0288005

EPY0000492

EPY0000453

50 mg

20 mg

20 mg

50 mg

100 mg

150 mg

150 mg

10 mg

100 mg

50 mg

EPO0290000

EPY0001044

EPO0400000

EPO0500000

EPO0700000

EPO0770000

EPY0000698

EPY0000699

EPY0000700

EPY0000719

EPY0000739

EPP0090000

EPY0000524

EPP0100000

EPP0200000

EPP0250000

EPY0000577

EPY0000835

EPY0001001

EPP0270000

EPP0300000

EPY0000780

EPY0000058

EPY0000913

EPY0000912

EPP0305000

EPY0000578

EPY0000281

EPY0000233

EPY0000579

80 mg

10 mg

100 mg

20 mg

1 mg

0.2 mg

40 mg

5 mg

10 mg

10 mg

1 mg

100 mg

10 mg

2000 mg

2000 mg

20 mg

20 mg

20 mg

0.5055 mg

25 mg

50 mg

10 mg

unit

10 mg

10 mg

250 mg

100 mg

200 mg

15 mg

10 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 291

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000256 Paroxetine impurity D (3R,4S)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine ((+)-trans- paroxetine)

Paroxetine impurity E (3RS,4RS)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4fluorophenyl)piperidine (cis-paroxetine)

Paroxetine hydrochloride (anhydrous) impurity H [(3S,4R)-1-benzyl-4-(4-fluorophenyl)piperidin-3-yl]methanol

Paroxetine for system suitability

Pefloxacin mesilate dihydrate

Pefloxacin impurity B 1-ethyl-6-chloro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (chlorinated homologue of pefloxacin)

Pefloxacin impurity C 1-ethyl-6-fluoro-5-(4-methylpiperazin-1yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (isopefloxacin)

Penbutolol sulfate

Penbutolol impurity A (2S)-1-[2-(cyclopent-1-enyl)phenoxy]-3-[(1,1-dimethylethyl)amino]propan-2-ol

Penicillamine

Penicillamine disulphide 3,3-(disulphanediyl)bis[(2)-2-amino-3-methylbutanoic]acid

Pentamidine diisetionate

Pentazocine - Reference Spectrum

Pentazocine hydrochloride - Reference Spectrum

Pentazocine lactate - Reference Spectrum

Pentetate sodium calcium

Pentobarbital Controlled Substance

Pentoxifylline

Pentoxyverine hydrogen citrate - Reference Spectrum

Pentoxyverine impurity A 1-phenylcyclopentanecarboxylic acid

Pentoxyverine impurity B 2-(diethylamino)ethyl-1-phenylcyclopentanecarboxylate (caramiphen)

Pepsin powder

Pergolide mesilate

Perindopril impurity A (2S,3aS,7aS)-octahydro-1Hindole-2-carboxylic acid

Perindopril for stereochemical purity

Perindopril tert-butylamine

Perindopril for peak identification

Perphenazine

Perphenazine for system suitability

Pertussis toxin BRP

Pethidine hydrochloride - Reference Spectrum Pethidine impurity A 1-methyl-4-phenylpiperidine (MPP)

Phenazone

Phenazone impurity A 5-methyl-2-phenyl-2,4-dihydro-3-pyrazol-3-one

Pheniramine impurity A 2-Benzylpyridine

Pheniramine maleate

Phenobarbital Controlled Substance

Phenobarbital impurity A (5RS)-5-ethyl-2,6-diimino-5-phenyltetrahydropyrimidin-4(1H)-one

Phenobarbital impurity B (5RS)-5-ethyl-6-imino-5-phenyldihydropyrimidine-2,4(1H,3H)-dione

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg

EPY0000580

EPY0000581

EPY0000630

EPP0309000

EPP0309020

5 mg

10 mg

5 mg

200 mg

10 mg

EPP0309030 0.01 mg

EPP0307000

EPP0307005

EPP0310000

EPP0320000

EPP0405000

EPP0405500

EPP0405510

EPY0000417

EPY0001051

EPP0500000

EPP0510000

EPY0000076

EPY0000098

EPY0000099

EPP0525000

EPY0000010

EPY0000237

EPY0000207

EPY0000238

EPY0000771

EPP0550000

EPY0001045

EPY0000021

EPP0600000

EPP0600002

EPP0800000

EPY0001138

New EPY0001428

EPP0850000

EPP0900000

EPY0001350

EPY0001351

100 mg

20 mg

100 mg

100 mg

30 mg

unit

unit

unit

100 mg

500 mg

100 mg

unit

10 mg

10 mg

2000 mg

150 mg

10 mg

40 mg

40 mg

5 mg

100 mg

5 mg

2x0.05 mg

unit

20 mg

20 mg

20 mg

20 mg

250 mg

200 mg

15 mg

15 mg

292 Edition 2012/2013

Page 43: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPP0950000

EPP1000000

EPP1100000

EPP1109000

EPY0001127

EPY0001251

EPP1150000

EPP1200000

EPY0000147

EPP1240000

EPP1250000

EPY0000683

EPY0000229

EPP1255100

EPP1260000

EPP1290000

EPY0001167

EPP1300000

EPY0000493

EPY0000761

EPY0000798

EPY0000766

EPP1500000

EPP1600000

EPP1605000

EPP1609000

EPP1609010

EPP1645000

EPP1645005

EPY0000124

EPY0000123

EPP1650000

EPP1700000

EPY0000106

EPY0000525

EPY0000401

EPP1750000

EPP1800000

New EPY0001519

New EPY0001520

New EPY0001476

EPY0000061

EPP1890000

EPP1900000

EPP2000000

EPP2100000

EPY0000288

EPY0000038

Phenoxyethanol

Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium

Phentolamine mesilate - Reference Spectrum

Phentolamine mesilate

Phentolamine mesilate for system suitability

Phenylalanine

Phenylbutazone

Phenylbutazone impurity B (4-butyl-4-hydroxy-1,2-diphenyl-3,5)pyrazolidinedione

Phenylephrine

Phenylephrine hydrochloride

Phenylephrine hydrochloride for peak identification

Phenylmercuric acetate - Reference Spectrum

Phenylmercuric borate - Reference Spectrum

Phenylpropanolamine hydrochloride (Norephedrin hydrochloride) Drug Precursor

Phenytoin

Phenytoin for system suitability

Phenytoin sodium

Phloroglucinol (anhydrous)

Pholcodine Controlled Substance

Pholcodine for peak identification Controlled Substance Phthalic acid benzene-1,2-dicarboxylic acid

Phthalylsulfathiazole

Physostigmine salicylate

Physostigmine sulfate

Phytomenadione

trans-Epoxyphytomenadione

Picotamide monohydrate

Picotamide impurity A 4-methoxybenzene-1,3-dicarboxylic acid

Pidolate impurity B (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid

Pidolic acid

Pilocarpine hydrochloride

Pilocarpine nitrate

Pilocarpine nitrate for system suitability

Pimobendan

Pimobendan for system suitability

Pimozide

Pindolol

Pioglitazone for system suitability

Pioglitazone hydrochloride

Pipemidic acid trihydrate

Pipemidic acid trihydrate - Reference Spectrum

Piperacillin

Piperazine adipate

Piperazine citrate

Piperazine hydrate

Piracetam

Pirenzepine dihydrochloride monohydrate

2 mL

250 mg

250 mg

unit

10 mg

10 mg

60 mg

100 mg

20 mg

60 mg

50 mg

2 mg

unit

unit

50 mg

100 mg

20 mg

250 mg

210 mg

10 mg

10 mg

20 mg

100 mg

100 mg

100 mg

150 mg

10 mg

125 mg

25 mg

60 mg

125 mg

50 mg

50 mg

20 mg

10 mg

0.1 mg

150 mg

100 mg

15 mg

120 mg

15 mg

unit

100 mg

250 mg

250 mg

250 mg

120 mg

250 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 293

Page 44: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPP2120000

New EPY0001458

EPP2120002

EPP2130000

EPP2150000

EPP2152000

EPP2152015

Piretanide

Piretanide for system suitability

Piretanide impurity A 4-phenoxy-3(1H-pyrrol-1-yl)-5-sulphamoylbenzoic acid

Piroxicam

Pivampicillin

Pivmecillinam hydrochloride

Pivmecillinam impurity C methylene 2,2-dimethylpropanoate (2RS,4S)-2-[[[(hexahydo-1H-azepin-1-yl) methylene]amino]methyl]-5,5-dimethylthiazolidin-4-carboxylate

Plastic additive 01 (2RS)-2-ethylhexyl)benzene-1,2-dicarboxylate

Plastic additive 03 N,N'-ethylenedialcanamide

Plastic additive 04 Epoxidised soya oil

Plastic additive 05 Epoxidised linseed oil

Plastic additive 08 Ethylene bis [3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate]

Plastic additive 09 pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Plastic additive 10 4,4',4''-(2,4,6-trimethylbenzene-1,3,5-triyltrismethylene)-trio[2,6-bis(1,1-dimethylethyl)phenol]

Plastic additive 11 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate

Plastic additive 12 Tris(2,4-di-1,1-dimethylethylphenyl)phosphite R

Plastic additive 13 1,3,5-tris(3,5-di-1,1-dimethylethyl-4-hydroxybenzyl)-1H,3H,5H-1,3,5-triazine-2,4,6-trione

Plastic additive 14 2,2'-Di(octadecycloxy)5,5'-spirobi(1,3,2,-dioxaphosphorinane) R

Plastic additive 15 Dioctadecyl disulphide

Plastic additive 16 Didodecyl 3,3'-thiodipropionate R

Plastic additive 17 Dioctadecyl 3,3'-thiodipropionate R

Plastic additive 18

Plastic additive 20 Oleamide R

Plastic additive 21 Erucamide R

Plastic additive 22 Copolymer of dimethyl butanedioate and 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol Synonyms: copolymer of dimethyl succinate and (4-hydroxy-2,2,6,6-tetramethylpiperidin-1- yl)ethanol

Plastic additive 23 di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetate containing about 27% of (tri(isooctyl)2,2',2''-[monooctylstannylidyne)tris(thio)]triacetate Tin-content of 15.4%

Poliomyelitis vaccine (inactivated) BRP

Poliomyelitis vaccine (oral) BRP

Poloxamer 124

Poloxamer 188

Poloxamer 237

Poloxamer 338

Poloxamer 407

Polyacrylate - Reference Spectrum

Polymyxin B sulfate

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

10 mg

20 mg

100 mg

50 mg

100 mg

10 mg

EPP2155001

EPP2155003

EPE0800000

EPP2155005

EPP2155008

EPP2155009

EPP2155010

EPP2155011

EPP2155012

EPP2155013

EPP2155014

EPP2155015

EPP2155016

EPP2155017

EPP2155018

EPO0140000

EPE1260000

EPP2155022

2 mL

100 mg

500 mg

500 mg

500 mg

250 mg

250 mg

500 mg

250 mg

250 mg

250 mg

500 mg

250 mg

250 mg

100 mg

100 mg

100 mg

100 mg

EPP2155023 200 mg

EPP2160000

EPP2161000

EPP2163920

EPP2164009

EPP2164020

EPP2164021

EPP2164030

EPP2170000

EPP2400000

294

5x0.5 mL

5x1 mL

30 mg

100 mg

100 mg

100 mg

100 mg

unit

25 mg

Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000355

EPY0000289

EPY0000290

EPY0000291

EPY0000007

EPY0000792

EPP2600000

EPP2649610

EPY0001168

EPY0000315

EPP2650000

EPY0001275

EPP2660000

EPY0000466

EPY0001266

EPY0001187

EPY0001267

EPY0000215

EPY0000223

Polymyxin B sulfate for microbiological assay

Polysorbate 20 - Reference Spectrum

Polysorbate 40 - Reference Spectrum

Polysorbate 60 - Reference Spectrum

Polysorbate 80 - Reference Spectrum

Poly(vinyl acetate) dispersion 30%

Poly(vinyl chloride)

Potassium clavulanate - Reference Spectrum

Potassium clavulanate impurity G

Potassium hydrogen aspartate hemihydrate

Potassium sorbate

Potassium sucrose octasulfate

Povidone

Povidone (iodinated)

Pramipexole dihydrochloride monohydrate

Pramipexole for system suitability

Pramipexole impurity D (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine

Pravastatin sodium - Reference Spectrum

Pravastatin impurity A (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)- 2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid (6'-epipravastatin)

Pravastatin 1,1,3,3-tetramethylbutylamine

Prazepam Controlled Substance

Praziquantel

Praziquantel impurity A (11bRS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one

Prazosin hydrochloride

Prednicarbate

Prednicarbate for system suitability

Prednicarbate impurity F 1,2-dihydroprednicarbate

Prednisolone

Prednisolone for peak identification

Prednisolone for system suitability

Prednisolone acetate

Prednisolone acetate for peak identification

Prednisolone hexanoate

Prednisolone pivalate

Prednisolone sodium phosphate

Prednisone

Pregnenolone isobutyrate

Prekallikrein activator in albumin BRP

Prilocaine

Prilocaine hydrochloride

Prilocaine impurity B 2-methylbenzenamine hydrochloride

Prilocaine impurity E (RS)-N-(methylphenyl)-2-(propylamino)propanamide

Primaquine diphosphate

Primidone

Primidone for peak identification

25 mg

unit

unit

unit

unit

1500 mg

100 mg

unit

5 mg

50 mg

100 mg

100 mg

50 mg

10 mg

5 mg

15 mg

5 mg

unit

0.1 mg

EPY0000204

EPP2669000

EPP2670000

EPP2675000

EPP2680000

EPP2698000

New EPY0001443

EPP2698060

EPP2700000

EPY0001359

EPY0001355

EPP2800000

EPY0000582

EPP2804000

EPP2805000

EPP2810000

EPP2900000

EPP2920000

EPY0000263

EPP2939000

EPP2939060

New EPY0001408

EPP2939025

EPP2940000

EPP2950000

EPY0000369

30 mg

50 mg

150 mg

10 mg

50 mg

100 mg

10 mg

10 mg

150 mg

10 mg

10 mg

120 mg

10 mg

10 mg

100 mg

100 mg

100 mg

150 mg

3x1 mL

150 mg

100 mg

80 mg

25 mg

500 mg

150 mg

5 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 295

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Table of content

European Pharmacopoeia

Code Product Unit

EPP3000000

EPP3050000

EPP3090000

EPP3100000

EPP3200000

EPP3300000

EPY0000148

EPY0000179

EPY0000181

EPY0000182

EPP3350000

EPP3390000

EPP3400000

EPY0000769

EPY0000797

EPP3490000

EPY0000455

EPY0000456

Probenecid

Procainamide hydrochloride

Procaine benzylpenicillin

Procaine hydrochloride

Prochlorperazine maleate

Progesterone

Progesterone impurity C (20R)-20-hydroxypregn-4-en-3-one

Proguanil hydrochloride - Reference Spectrum

Proguanil impurity C 1,5-bis(4-chlorophenyl)biguanide

Proguanil impurity D 1,5-bis(1-methylethyl)biguanide

Proline

Promazine hydrochloride

Promethazine hydrochloride

Promethazine impurity D (2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide

Promethazine for peak identification

Propacetamol hydrochloride - Reference Spectrum

Propafenone hydrochloride

Propafenone impurity B 2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy] phenyl]-3-phenylprop-2-en-1-one

Propanol - Reference Spectrum

Propofol

Propofol for peak identification

Propofol impurity J 2,6-bis (1-methylethyl)-1,4-benzoquinone

Propranolol hydrochloride

Propranolol hydrochloride for performance test

Propylene glycol dilaurate

Propylene glycol monolaurate

Propyl gallate

Propyl parahydroxybenzoate

Propylthiouracil

Propyphenazone

Protirelin

D-His Protirelin

Proxyphylline

Pseudoephedrine hydrochloride Drug Precursor

Pseudoisoeugenyl 2-methylbutyrate for peak identification

Purpureaglycoside A

Purpureaglycoside B

Pyrantel embonate

Pyrantel impurity A 1-methyl-2-[(Z)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine

Pyrazinamide

Pyridostigmine bromide

Pyridostigmine impurity A pyridin-3-yl-dimethylcarbamate

Pyridostigmine bromide impurity B 3-hydroxy-1-methylpyridinium

Pyridoxine hydrochloride

100 mg

100 mg

250 mg

100 mg

100 mg

50 mg

10 mg

unit

10 mg

10 mg

60 mg

100 mg

50 mg

10 mg

10 mg

unit

10 mg

10 mg

EPY0000278

EPY0000016

EPY0000017

EPY0000018

EPP3500000

EPP3600000

EPY0000318

EPY0000319

EPP3640000

EPP3650000

EPP3700000

EPP3750000

EPP3760000

EPP3760020

EPP3800000

EPP3850000

EPY0000387

EPP3900000

EPP4000000

EPY0000402

EPY0000403

EPP4050000

EPP4099900

EPP4099910

New EPY0001486

EPP4100000

unit

290 mg

0.1 mL

20 mg

30 mg

20 mg

100 mg

100 mg

50 mg

150 mg

100 mg

200 mg

2x5.03 mg

0.1 mg

100 mg

50 mg

100 mg

25 mg

25 mg

10 mg

20 mg

30 mg

50 mg

20 mg

10 mg

100 mg

296 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 47: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0001226

EPP4200000

EPY0000659

EPY0001009

EPQ0100000

EPQ0200000

EPR0100000

EPY0000896

EPY0000897

EPY0000898

EPY0000902

EPY0001134

EPY0001135

EPR0145000

EPR0145005

Pyridoxine impurity A 6-methyl-1,3-dihydrofuro[3,4-c]pyridin-7-ol

Pyrimethamine

Pyrrolidone

Quercetin dihydrate

Quinidine sulfate

Quinine sulfate

Rabies vaccine (inactivated) for veterinary use BRP

Racecadotril

Racecadotril impurity A Ethanethioic acid

Racecadotril impurity G benzyl[[(2RS)-2-benzyl-3-sulfanylpropanoyl]amino]acetate

Racecadotril for peak identification

Raloxifene hydrochloride

Raloxifene hydrochloride for peak identification

Ramipril

Ramipril impurity A (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino] propanoly]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril methylester)

Ramipril impurity B (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-[(methylethoxy)carbonyl]-3-phenylpropyl] amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril isopropyl ester)

Ramipril impurity C (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(ethoxycarbonyl)-3-cyclohexylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (hexahydroramipril)

Ramipril impurity D ethyl(2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro -1H-cyclopenta[e]pyrrolo[1,2a]pyrazin-2-yl]-4-phenylbutanoate (ramipril diketopiperazine)

Ranitidine hydrochloride

Ranitidine impurity J 1,1'-N-[methylenebis(sulphanediylethylene)]bis (N'-methyl-2-nitroethene-1,1-diamine)

Ranitidine for system suitability

Repaglinide

Repaglinide for system suitability

Repaglinide impurity E 2-ethoxy-4-[2-[[(1R)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]- 2-oxoethyl]benzoic acid

Reserpine

Residual solvents solution class I

Resorcinol

Retinol acetate

Retinol ester

Reviparin sodium

Ribavirin

Riboflavin (Vitamine B2)

Riboflavin for peak identification

Riboflavine sodium phosphate

Ribonucleic acid

Rifabutin

Rifabutin impurity A 1-(2-methylpropyl)piperidin-4-one

Rifampicin

Rifampicin quinone

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg

250 mg

20 mg

20 mg

300 mg

300 mg

3x86 mg

110 mg

1 mL

10 mg

5 mg

110 mg

10 mg

20 mg

10 mg

EPR0145010 10 mg

EPR0145015 10 mg

EPR0145020 10 mg

EPR0150000

EPY0000416

100 mg

0.00025 mg

EPY0000411

EPY0000457

EPY0000458

EPY0000459

EPR0200000

EPR0250000

EPY0000767

EPR0300000

EPR0290000

EPR0500500

EPY0000377

EPR0600000

EPY0000757

EPR0630000

EPY0000662

EPY0000149

EPY0000184

EPR0700000

EPR0800000

Edition 2012/2013

20 mg

20 mg

6 mg

10 mg

100 mg

1.4 mL

20 mg

1000 mg

100 mg

250 mg

2x150 mg

100 mg

0.12 mg

250 mg

100 mg

150 mg

20 mg

100 mg

100 mg

297

Page 48: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPR0900000

EPR0950000

EPR1000000

EPY0001074

EPY0001075

EPY0000250

EPY0000187

EPR1000600

EPY0000370

EPY0001276

Rifamycin B

Rifamycin S

Rifamycin sodium

Rifaximin

Rifaximin for system suitability

Rilmenidine dihydrogenophosphate - Reference Spectrum

Rilmenidine for system suitability

Risperidone

Risperidone for system suitability

Risperidone impurity K 3-[2-[4-(1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4Hpyrido[1,2- a]pyrimidin-4-one (desfluoro risperidone)

Ritonavir

Ritonavir for peak identification

Rivastigmine for system suitability

Rizatriptan benzoate

Rizatriptan for system suitability

RK 13 cells cell lines (kidney,rabbit) titration of live measles, mumps and rubella vaccines

Rocuronium bromide - Reference Spectrum

Rocuronium for peak identification

Ropivacaine hydrochloride monohydrate

Ropivacaine impurity G (+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-ropivacaine)

Rosmarinic acid

Roxithromycin

Roxithromycin for system suitability

Rubella vaccine (live) BRP

Ruscogenins

Rutoside trihydrate

Saccharin

Saccharin Sodium

Salbutamol

Salbutamol impurity B (1RS)-2-[(1,1-dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol

Salbutamol impurity D 5-[(1RS)-2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2- hydroxybenzaldehyde

Salbutamol impurity F 1,1'[oxybis[methylene(4-hydroxy-1,3-phenylene)]]bis [2-[(1,1-dimethylethyl)amino]ethanol]

Salbutamol impurity G 2-[benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-hydroxymethyl) phenyl]ethanone

Salbutamol impurity I (1RS)-2-[(1,1-dimethylethyl)amino]-1-[3-(hydroxymethyl)-4-benzyloxyphenyl] ethanol

Salbutamol impurity J 2-[(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone (salbutamone)

Salbutamol sulfate

Salbutamol sulfate for system suitability

Salicin

Salicylic acid

Salicylic acid impurity B 4-hydroxyisophthalic acid

Salmeterol xinafoate

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg

50 mg

300mg

160 mg

10 mg

unit

30 mg

50 mg

20 mg

0.015 mg

EPY0000714

EPY0000706

New EPY0001485

New EPY0001302

New EPY0001303

EPR1300000

80 mg

10 mg

1.0114 mg

200 mg

15 mg

2x1 mL

EPY0000594

EPY0000527

EPY0000742

EPY0000743

EPY0000786

EPR1500000

EPY0000220

EPR2000000

EPY0000494

EPY0000105

EPS0040000

EPS0050000

EPS0100000

EPY0000030

EPY0000071

unit

10 mg

10 mg

5 mg

40 mg

125 mg

5 mg

5x18 mg

10 mg

100 mg

30 mg

50 mg

50 mg

5 mg

5 mg

EPY0000031 5 mg

EPY0000034 5 mg

EPY0000032

EPY0001186

EPS0150000

EPY0001288

EPY0000669

EPS0200000

EPY0000405

EPY0000422

298

0.006 mg

0.00045 mg

50 mg

10 mg

50 mg

100 mg

10 mg

50 mg

Edition 2012/2013

Page 49: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000423

EPY0001052

EPY0001049

EPY0001056

New EPY0001483

EPY0000814

EPY0000815

EPS0360000

EPS0360090

EPS0400000

EPS0450000

EPS0460000

EPY0000828

EPY0000866

EPY0000867

EPY0001285

EPY0000371

EPY0001046

EPS0500000

EPS0600000

EPS0650000

EPY0001066

EPS0660000

EPY0000014

EPS0695000

EPY0000300

EPY0000039

EPS0700000

EPS0710000

EPS0750000

EPY0001300

EPS0760000

New EPY0001410

EPS0781000

EPS0780000

New EPY0001468

EPY0000620

EPY0000808

EPY0000809

EPS0785000

EPY0001104

EPY0000210

EPY0000268

EPS0800000

EPS0808000

EPS0808060

EPS0900000

EPS0930000

EPS0945000

EPS0947000

Salmeterol xinafoate for system suitability

Santonin

Saquinavir mesilate

Saquinavir for system suitability

Saw palmetto extract

Selamectin

Selamectin for system suitability

Selegiline hydrochloride

(RS)-Selegiline hydrochloride

Senna extract

Serine

Sertaconazole nitrate

Sertraline hydrochloride

Sertraline for peak identification

Sertraline for system suitability

Sertraline impurity E

Sestamibi labelling kit

Sevoflurane

Silicone elastomer

Silicone oil

Simvastatin

Simvastatin for peak identification

Sisomicin sulfate

Sodium alendronate

Sodium amidotrizoate

Sodium aminosalicylate dihydrate - Reference Spectrum

Sodium ascorbate

Sodium calcium edetate

Sodium cetostearyl sulfate

Sodium cromoglicate

Sodium cromoglicate for system suitability

Sodium cyclamate

Sodium fusidate

Sodium hyaluronate - Reference Spectrum

Sodium hyaluronate BRP

Sodium iodohippurate

Sodium laurilsulfate

Sodium phenylbutyrate

Sodium phenylbutyrate impurity C 4-cyclohexylbutanoic acid

Sodium picosulfate

Picosulfate for system suitability

Sodium polystyrene sulphonate - Reference Spectrum

Sodium propionate - Reference Spectrum

Sodium salicylate

Sodium stearyl fumarate

Sodium stearyl maleate

Sodium taurocholate BRP

Sodium valproate

Somatostatin

Somatropin

25 mg

20 mg

70 mg

0.3033 mg

8g

100 mg

5 mg

50 mg

25 mg

50 mg

50 mg

125 mg

200 mg

5.4 mg

6.18 mg

15 mg

22 mg

1 mL

2000 mg

1 mL

100 mg

10 mg

50 mg

150 mg

125 mg

unit

50 mg

100 mg

100 mg

10 mg

20 mg

100 mg

10 mg

unit

300 mg

15 mg

40 mg

5 mg

10 mg

100 mg

0.5 mg

unit

unit

100 mg

50 mg

10 mg

10000 mg

150 mg

2.45 mg

55 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 299

Page 50: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000711

EPS0950000

EPY0000385

EPS1000000

EPY0000114

EPY0000115

EPY0001011

EPY0000597

EPY0000549

EPY0000655

EPY0001126

EPS1100000

EPY0000381

EPY0000332

EPS1200000

EPY0001295

EPY0000185

EPY0001050

EPY0001091

EPS1250000

EPS1250010

New EPY0001420

EPS1300000

EPY0000408

EPY0000421

EPS1340000

EPS1350000

EPY0000868

EPS1400000

EPS1500000

EPY0001324

EPY0001344

EPY0001342

Somatropin/desamidosomatropin resolution mixture

Sorbic acid

1,4-Sorbitan

Sorbitol

Sotalol hydrochloride

Sotalol impurity B N-[4-[[(1-methylethyl)amino]acetyl]phenyl]methanesulphonamide

Spanish sage oil for peak identification

Spectinomycin hydrochloride

Spectinomycin for system suitability

Spectinomycin sulphate tetrahydrate

Spike lavender oil

Spiramycin

Spirapril hydrochloride monohydrate

Spirapril for system suitability

Spironolactone

Spironolactone for system suitability

Squalane

St.John's wort standardised dry extract

Standardised artichoke leaf dry extract

Stanozolol

Stanozolol impurity A (5α,17β)-17-hydroxy-17-methylandrostan-3-one

Stanozolol impurity B

Starch BRP

Stavudine

Stavudine for system suitability

Stearic acid Plastic additive 19

Stearyl alcohol

Streptokinase for system suitability

Streptomycin sulphate

Succinylsulfathiazole

Sucralfate

Sucralose

Sucralose impurity B 1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 6-chloro-6-deoxy-α-D-glucopyranoside (1‘,6,6‘-trichloro-1‘,6,6‘-trideoxysucrose)

Sucrose

Sufentanil - Reference Spectrum

Sufentanil citrate - Reference Spectrum

Sulbactam sodium

Sulbactam

Sulbactam for peak identification

Sulfacetamide sodium

Sulfadiazine

Sulfadiazine impurity A 2,6-dimethylaniline

Sulfadiazine for identification of impurity F

Sulfadimidine

Sulfadoxine

Sulfafurazole

Sulfaguanidine

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

33 mg

10 mg

50 mg

1200 mg

25 mg

20 mg

250 mg

100 mg

20 mg

10 mg

400 µl

200 mg

60 mg

15 mg

150 mg

2.055 mg

0.25 mL

500 mg

60 mg

50 mg

10 mg

10 mg

50000 mg

100 mg

10 mg

100 mg

250 mg

30 µl

100 mg

100 mg

10 mg

550 mg

0.5 mg

EPS1600000

EPS1608100

EPS1609000

EPY0000529

EPY0000528

EPY0000550

EPS1700000

EPS1800000

New EPY0001469

New EPY0001480

EPS1900000

EPS1950000

EPS1975000

EPS1975600

300

100 mg

unit

unit

10 mg

150 mg

20 mg

50 mg

100 mg

20 mg

15 mg

100 mg

50 mg

100 mg

60 mg

Edition 2012/2013

Page 51: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPS2000000

EPS2050000

EPS2100000

EPY0000412

EPY0000413

EPS2150000

EPS2151000

EPS2159100

EPS2155000

EPS2155010

EPS2158000

EPS2159000

EPY0001238

EPS2159010

EPS2159015

EPS2160000

EPS2180000

EPS2190000

EPS2191000

EPS2192000

EPY0000530

EPY0000531

EPY0000532

EPY0000022

EPY0000026

EPY0000027

EPS2200000

EPS2400000

EPS2400004

EPS2400006

EPS5000001

EPS5000002

New EPY0001417

EPT0010000

EPT0014000

EPT0015000

EPY0000650

EPY0000653

EPY0000651

EPY0000652

EPY0001102

EPY0001047

EPY0000648

Sulfamerazine

Sulfamethizole

Sulfamethoxazole

Sulfamethoxazole impurity A N-(4-(5-methyl)-isoxazol-3-ylsulphamoyl)phenylacetamide

Sulfamethoxazole impurity F 4-amino-N-(3-methylisoxazol-5-yl)benznesulphonamide

Sulfamethoxypyridazine

Sulfanilamide

Sulfapyridine

Sulfasalazine

Sulfasalazine derivative for resolution 2-hydroxy-5-[[4-[[(6-methylpyridin-2-yl)amino]-sulfonyl]phenyl]azo]benzoic acid

Sulfathiazole

Sulfinpyrazone

Sulfinpyrazone for system suitability

Sulfinpyrazone impurity A 1,2-diphenyl-4-(2-phenylsulphonylethyl)pyrazolidine-3,5-dione

Sulfinpyrazone impurity B 1,2-diphenyl-4-(2-phenylthioethyl)pyrazolidine-3,5-dione

Sulfisomidine

Sulindac

Sulpiride

Sulpiride impurity A [(2RS)-1-ethylpyrrolidin-2-yl]methanamine

Sulpiride impurity B methyl 2-methoxy-5-sulphamoylbenzoate

Sultamicillin

Sultamicillin tosilate

Sultamicillin for peak identification

Sumatriptan succinate

Sumatriptan impurity mixture

Sumatriptan for system suitability

Suxamethonium chloride

Suxibuzone

Suxibuzone impurity B (4-butyl-3,5-dioxo-1,2-diphenylpyrazolidin-4-yl)methyl ethyl butanedioate

Suxibuzone impurity C 4-butyl-4-(hydroxymethyl)-1,2-diphenyl-1,2-dihydro-4H-pyrazole-3,5-dione

Swine erysipelas bacteria, serotyp 1 (for vaccines-vet.use) BRP

Swine erysipelas bacteria, serotyp 2 (for vaccines-vet.use) BRP

Tadalafil

Talampicillin hydrochloride

Tamoxifen citrate

Tamoxifen citrate for performance test

Tamsulosin hydrochloride

Tamsulosin racemate

Tamsulosin impurity D 2-methoxy-5[(2R)-2-[[2-(2-methyoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide

Tamsulosin impurity H (2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4-methoxyphenyl)propan-2-amine

Teicoplanin

Teicoplanin for identification

Telmisartan

100 mg

100 mg

50 mg

5 mg

5 mg

50 mg

100 mg

20 mg

2x250 mg

20 mg

100 mg

30 mg

0.5 mg

20 mg

20 mg

50 mg

50 mg

100 mg

20 mg

20 mg

10 mg

200 mg

10 mg

50 mg

3 mg

2 mg

1000 mg

50 mg

10 mg

10 mg

1 mg

1 mg

200 mg

50 mg

80 mg

30 mg

10 mg

10 mg

10 mg

10 mg

52 mg

40 mg

30 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 301

Page 52: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPY0000649

EPY0001003

EPT0040000

EPY0000344

Telmisartan for peak identification

Telmisartan for system suitability

Temazepam Controlled Substance

Temazepam impurity C (3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl acetate Controlled Substance

Temazepam impurity D (3RS)-7-chloro-3-methoxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one Controlled Substance

Temazepam impurity F (5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione

Temazepam impurity G (5RS)-7-chloro-1,4-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione

Tenoxicam

Tenoxicam impurity mixture

Terazosin hydrochloride dihydrate

Terazosin for system suitability

Terazosin impurity A 2-chloro-6,7-dimethoxyquinazolin-4-amine

Terazosin impurity E 2,2`-(piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine) Terazosin impurity L 1-(furan-2-ylcarbonyl)piperazine

Terazosin impurity N 1-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine

Terbinafine hydrochloride

Terbinafine for system suitability

Terbutaline sulfate

Terbutaline impurity C 1-(3,5-dihydroxyphenyl)-2-[(1,1- dimethylethyl)amino]-ethanone

Terconazole

Terfenadine

Terfenadine impurity A 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butan-1-one (ketone)

Testosterone

Testosterone caproate

Testosterone decanoate

Testosterone decanoate for system suitability

Testosterone enantate

Testosterone enantate for peak identification

Testosterone enantate for system suitability

Testosterone enantate impurity H delta-5-testosterone-3,17-dienantate

Testosterone for impurity D identification

Testosterone for system suitability

Testosterone isocaproate

Testosterone isocaproate for system suitability

Testosterone propionate

Testosterone propionate for system suitability

Tetanus vaccine (adsorbed) BRP

Tetra-O-acetyl-mannose triflate

Tetracaine hydrochloride

Tetracaine for system suitability

Tetracosactide

10 mg

0.26 mg

50 mg

5 mg

EPY0000345 5 mg

EPY0000346

EPY0000347

EPT0040800

EPY0001114

EPY0000621

EPY0000666

EPY0000622

EPY0000665

EPY0000623

EPY0000624

EPY0000535

EPY0001143

EPT0050000

EPT0050015

EPT0060000

EPT0071000

EPT0080000

5 mg

5 mg

100 mg

0.0042 mg

40 mg

0.5 mg

10 mg

10 mg

10 mg

10 mg

10 mg

10 mg

100 mg

15 mg

250 mg

100 mg

20 mg

EPT0100000

EPT0210000

EPT0240000

EPY0000696

EPT0250000

EPY0001312

EPY0001317

EPY0001313

EPY0000342

EPY0000343

EPT0260000

EPY0000716

EPT0300000

New EPY0001409

EPT0400000

EPY0001087

EPT0500000

EPY0001002

EPT0550000

30 mg

50 mg

50 mg

0.4 mg

100 mg

10 mg

20 mg

10 mg

20 mg

20 mg

50 mg

5 mg

60 mg

5 mg

30 mg

60 mg

100 mg

2 mg

2x0.366mg

302 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 53: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPT0600000

EPY0001165

EPY0000015

EPY0000008

EPY0000460

EPY0000723

EPT0700000

EPT0800000

EPY0000294

EPY0000336

EPY0000372

EPY0000373

EPY0000467

EPY0000059

Tetracycline hydrochloride

Tetrandrine

Tetrazepam - Reference Spectrum

Tetrazepam impurity C 7-chloro-5-cyclohexyl-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one

Tetryzoline hydrochloride

Thebaine Controlled Substance

Theobromine

Theophylline

Theophylline - Reference Spectrum

Thiamazole

Thiamazol impurity A 2,2-dimethoxy-N-methylethanamine

Thiamazol impurity C 1-methyl-2-(methylsulphanyl)-1H-imidazole

Thiamine hydrochloride

Thiamine impurity E 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl) 4-methyl-4-thiazolidine-2-thione

Thiamine nitrate - Reference Spectrum

Thiamphenicol

Thioctic acid

Thioctic acid for system suitability

Thioctic acid containing impurity B

Thiomersal

Thiopental

Thiopental for system suitability

Thioridazine

Thioridazine hydrochloride

Thioridazine for system suitability

Thioxanthene

Thioxanthone

Threonine

Thymol

Tiabendazole

Tiamulin for peak identification

Tiamulin hydrogen fumarate

Tiamulin - Reference Spectrum

Tianeptine sodium - Reference Spectrum

Tianeptine for system suitability

Tianeptine impurity A ethyl 7-bromoheptanoate

Tiapride hydrochloride

Tiapride N-oxide

Tiaprofenic acid

Tiaprofenic acid impurity C (2RS)-2-(5-benzoylthiophen-3-yl)propanoic acid

Tibolone - Reference Spectrum

Tibolone for system suitability

Ticarcillin monosodium

Ticarcillin impurity A (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[[(thiophen-3-yl)acetyl]-amino]-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic acid (decarboxyticarcillin)

Ticlopidine hydrochloride

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg

20 mg

unit

20 mg

10 mg

10 mg

100 mg

100 mg

unit

125 mg

15 mg

20 mg

10 mg

10 mg

EPY0000060

EPT1100000

EPY0000546

EPY0000592

EPY0000545

EPY0000109

EPT1200000

New EPY0001478

EPY0000704

EPT1300000

EPY0000541

EPT1305100

EPT1305000

EPT1340000

EPT1350000

EPT1410000

EPY0000414

EPY0000333

EPY0000379

EPY0000151

EPY0000152

EPY0000153

EPT1405000

EPT1405050

EPT1410900

EPT1410910

EPY0000748

EPY0000668

EPY0000465

EPT1420010

unit

125 mg

110 mg

10 mg

30 mg

30 mg

500 mg

10 mg

10 mg

100 mg

0.21 mg

20 mg

10 mg

50 mg

50 mg

50 mg

10 mg

500 mg

unit

unit

30 mg

20 mg

60 mg

20 mg

50 mg

20 mg

unit

10 mg

250 mg

50 mg

EPT1423000

Edition 2012/2013

50 mg

303

Page 54: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPT1423025

EPY0000325

EPY0001270

EPT1450000

EPY0000644

EPT1470000

EPY0000899

EPT1471000

EPT1490000

EPY0000292

EPY0000282

EPY0001188

EPY0001216

EPY0001179

EPY0001189

EPT1500000

EPY0001210

EPY0000383

EPY0000384

EPT1550000

EPT1600000

EPT1610000

EPT1700000

EPY0000154

EPT1707000

EPY0001123

EPY0000461

EPY0000462

EPY0001366

EPY0000155

EPY0000156

EPY0000157

EPY0000072

EPY0000065

EPY0000066

Ticlopidine impurity F 6-(2-chlorobenzyl)4,5,6,7-tetrahydrothieno [3,2-c]pyridine

Tilidine hydrochloride hemihydrate - Reference Spectrum

Timolol for system suitability

Timolol maleate

(R)-timolol

Tinidazole

Tinidazole impurity A 2-methyl-5-nitro-1H-imidazole

Tinidazole impurity B 1-(2-ethylsulphonylethyl)-2-methyl-4-nitroimidazole

Tinzaparin sodium

Tioconazole - Reference Spectrum

Tioconazole for system suitability

Tiotropium bromide monohydrate

Tiotropium impurity F dithiophen-2-ylmethanone

Tiotropium impurity mixture

Tiotropium for system suitability

Tobramycin

Tobramycin for identification

All-rac-alpha-tocopherol for peak identification

All-rac-alpha-tocopheryl acetate for peak identification

alpha-Tocopherol

alpha-Tocopheryl acetate

RRR-alpha-Tocopheryl hydrogen succinate

Tolbutamide

Tolfenamic acid

Tolnaftate

Tolnaftate for system suitability

Torasemide anhydrous

Torasemide for system suitability

Torasemide impurity E ethyl [[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]carbamate

Tramadol hydrochloride

Tramadol impurity A (1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol

Tramadol impurity E (2RS)-2-[(dimethylamino)methyl]cyclohexanone

Tramazoline hydrochloride monohydrate

Tramazoline impurity A N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine

Tramazoline impurity B mixture of: 1-acetyl-2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazole and N-(4,5-dihydro-1H-imidazol-2-yl)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)acetamide

Trandolapril

Trandolapril impurity C (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1- (ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid (hexahydrotrandolapril)

Trandolapril impurity D ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]- 4-phenylbutanoate (trandolapril diketopiperazine)

Tranexamic acid

Trapidil

10 mg

unit

5.045 mg

100 mg

20 mg

100 mg

10 mg

20 mg

250 mg

unit

50 mg

10 mg

10 mg

0.08 mg

10 mg

51 mg

250 mg

15 mg

30 mg

500 mg

500 mg

150 mg

100 mg

100 mg

60 mg

10 mg

10 mg

5 mg

0.0006 mg

75 mg

15 mg

15 mg

20 mg

10 mg

10 mg

EPY0000501

EPY0000495

10 mg

10 mg

EPY0000496 10 mg

EPT1810000

EPT1820000

50 mg

50 mg

304 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013

Page 55: Code Product Unit - Эколан · 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004

Table of content

European Pharmacopoeia

Code Product Unit

EPT1820002

EPT1820004

EPY0001172

EPT1850000

EPT1899000

EPG0400010

EPT1899990

EPT1900000

New EPY0001459

EPT1950000

EPY0000050

EPY0000837

EPY0000870

EPT1975000

EPY0000165

EPY0000166

EPY0001055

EPY0000279

EPY0000799

EPT1977990

EPT1977995

EPT1978000

EPY0000111

EPT1985000

EPT1986000

EPT2000000

EPT2005000

EPT2005010

EPY0000720

EPY0000108

EPY0000068

EPT2009000

EPY0001260

EPY0001319

EPY0000092

EPY0000093

EPT2100000

EPT2200000

EPY0000684

EPT2200010

EPT2450000

EPT2500000

EPY0000759

EPT2500100

EPT2501200

Trapidil impurity A 5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol

Trapidil impurity B 1,2,4-triazol-3-amine

Trehalose dihydrate

Tretinoin

3,4,6-Tri-O-acetyl-D-glucal - Reference Spectrum

Triacetin - Reference Spectrum

Triamcinolone

Triamcinolone acetonide

Triamcinolone acetonide for system suitability

Triamcinolone hexacetonide

Triamcinolone impurity C 9-fluoro-11ß-16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione

Triamterene

Triamterene impurity B 2,7-diamino-6-phenylpteridin-4-ol

Triazolam Controlled Substance

Tribenoside

Tribenoside impurity A 3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)-α-D-glucofuranose

Tributyl acetylcitrate

Tri-n-butyl phosphate

Tributyl acetylcitrate for peak identification

Tricaprin

Tricaproin

Tricaprylin

Trichloroacetic acid - Reference Spectrum

Trichlorotrifluoroethane

Triethyl citrate - Reference Spectrum

Trifluoperazine hydrochloride

Triflusal

Triflusal impurity B 2-hydroxy-4-(trifluoromethyl)benzoic acid

Triglycerol diisostearate

Trihexyphenidyl hydrochloride

Trihexyphenidyl impurity A 1-phenyl-3-(piperidin-1-yl)propan-1-one

Trilaurin

Trimebutine for system suitability

Trimebutine maleate

Trimetazidine dihydrochloride - Reference Spectrum

Trimetazidine for system suitability

Trimethadione

Trimethoprim

Trimethoprim for system suitability

Trimethoprim impurity B (2,4-diaminopyrimidin-5-yl)(3,4,5- trimethoxyphenyl)methanone

Trimethyltetradecylammonium bromide

Trimipramine maleate

Trimipramine for peak identification

Trimyristin

Tristearin

20 mg

20 mg

250 mg

50 mg

unit

unit

150 mg

150 mg

10 mg

100 mg

10 mg

10 mg

0.5 mg

10 mg

150 mg

60 mg

1 mL

300 µL

25 mg

150 mg

40 mg

225 mg

unit

2.5 mL

unit

100 mg

50 mg

25 mg

200 mg

100 mg

20 mg

1250 mg

1.017 mg

10 mg

unit

50 mg

250 mg

50 mg

0.00075 mg

15 mg

200 mg

100 mg

0.51 mg

500 mg

100 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 305

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Table of content

European Pharmacopoeia

Code Product Unit

EPT2545000

EPY0001184

EPY0001183

EPT2550000

EPT2580000

EPY0001316

EPY0001247

EPY0001248

EPY0000616

EPY0000618

EPT2580300

EPY0000429

EPY0000432

EPY0000431

EPY0000430

EPY0000497

EPT2600000

EPT2610000

EPT2800000

EPT2880000

EPT2880100

EPY0000498

EPT2880200

EPT2900000

EPT3000000

EPU0020000

EPU0020001

EPU0020008

Trolamine

Trolamine impurity A Ethanolamine

Trolamine impurity B Diethanolamine

Trometamol

Tropicamide

Tropicamide for peak identification

Tropicamide impurity C (2RS)-3-hydroxy-2-phenylpropanoic acid (tropic acid)

Tropicamide impurity D Phenylacetic acid Drug Precursor

Tropisetron hydrochloride

Tropisetron impurity B 1H-indole-3-carboxylic acid

Tropine

Trospium chloride

Trospium impurity A Hydroxydiphenylacetic acid (benzilic acid)

Trospium impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl hydroxydiphenylacetate

Trospium impurity C (1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium]

Troxerutin

Trypsin BRP

Tryptophan

Tubocurarine chloride

Tylosin

Tylosin D

Tylosin phosphate for peak identification

Tylosin tartrate - Reference Spectrum

Tyrosine

Tyrothricin

Ubidecarenone

Ubidecarenone for system suitability

Ubidecarenone impurity D 5,6-dimethoxy-3-methyl-2-[(all-E)-3,7,11,15,19,23,27,31,35- nonamethylhexatriaconta-2,6,10,14,18,22,26,30,34-nonaenyl] benzene-1,4-dione

Uracil arabinoside

Urea

Ursodeoxycholic acid

Ursodeoxycholic acid for system suitability

Ursolic acid

Valaciclovir for system suitability

Valaciclovir hydrochloride (anhydrous)

Valaciclovir impurity D 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-ethyl-L-valinate

Valaciclovir impurity E 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-[(benzyloxy)carbonyl]-L-valinate

Valaciclovir impurity F para-toluenesulfonate 2-hydroxyethyl L-valinate

Valaciclovir impurity G N,N-dimethylpyridin-4-amine

Valerian standardised dry extract

Valine

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

2250 mg

250 mg

1 mL

100 mg

50 mg

10 mg

10 mg

10 mg

40 mg

10 mg

50 mg

10 mg

20 mg

20 mg

5 mg

30 mg

100 mg

100 mg

100 mg

150 mg

5 mg

10 mg

unit

50 mg

20 mg

50 mg

1 mg

5 mg

EPU0100000

EPU0600000

EPU0800000

EPY0001163

New EPY0001523

EPY0001225

EPY0000834

EPY0001096

EPY0001097

EPY0001098

EPY0001099

EPY0000583

EPV0030000

306

60 mg

100 mg

100 mg

1.26 mg

25 mg

10 mg

100 mg

10 mg

10 mg

12 mg

10 mg

400 mg

50 mg

Edition 2012/2013

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Table of content

European Pharmacopoeia

Code Product Unit

EPY0000584

EPY0000533

EPY0000585

EPY0000586

Valnemulin hydrochloride

Valnemulin hydrogen tartrate

Valnemulin for peak identification

Valnemulin impurity E (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro- 3a,9-propano-3aH-cyclopenta[8]annulen-8-yl 2-hydroxyacetate (pleuromulin)

Valproic acid

Valproic acid for system suitability

Valsartan

Valsartan for peak identification

Valsartan for system suitability

Vancomycin hydrochloride

Vanillin

Varicella vaccine (live)

Vecuronium bromide

Vecuronium for peak identification

Vedaprofen

Vedaprofen impurity mixture

Venlafaxine hydrochloride

Venlafaxine for system suitability

Verapamil hydrochloride

Verapamil impurity I (2RS)-2-(3,4-dimethoxyphenyl)-2-[2-[[2-(3,4)dimethoxyphenyl)- ethyl](methyl)amino]ethyl]3-methylbutanenitrile

Verapamil impurity M 5,5'-[[2-(3,4)dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)- 2-(1-methylethyl)pentanenitrile

Verbenalin

VERO cells

Vigabatrin

Vigabatrin impurity A (5RS)-5-ethenylpyrrolidin-2-one

Vigabatrin impurity B (2E)-2-(2-aminoethyl)but-2-enoic acid

Vigabatrin impurity D 4-aminobutanoic acid

Vigabatrin impurity E 2-[(2RS)-2-aminobut-3-enyl]propanedioic acid

Viscosimeter calibration liquids

Vinblastine sulphate

Vinblastine sulfate - Reference Spectrum

Vincristine sulphate

Vincristine sulfate - Reference Spectrum

Vindesine sulphate

Vindesine sulfate - Reference Spectrum

Vinorelbine tartrate

Vinorelbine impurity B 4-O-deacetylvinorelbine

Vinpocetine

Vinpocetine impurity A (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H- indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate)

Vinpocetine impurity B (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1- ij][1,5]naphthyridine-12-carboxylate (apovincamine)

10 mg

120 mg

20 mg

10 mg

EPV0033000

New EPY0001422

EPY0001132

EPY0001131

EPY0001145

EPV0045000

EPV0050000

EPY0001198

EPY0000561

EPY0000625

EPY0001093

EPY0001118

EPY0000587

EPY0000588

EPV0100000

EPV0100018

100 mg

10 mg

10 mg

10 mg

0.202 mg

100 mg

100 mg

420 mg

10 mg

10 mg

5 mg

0.006 mg

50 mg

1 mg

100 mg

5 mg

EPV0100026 10 mg

EPY0000661

EPV0180000

New EPY0001400

New EPY0001401

New EPY0001402

New EPY0001404

New EPY0001403

EPV0200000

EPV0300000

EPV0305000

EPV0400000

EPV0405000

EPV0500000

EPV0500010

EPY0000463

EPY0000464

EPY0000589

EPY0000590

11 mg

2x1 mL

10 mg

25 mg

20 mg

50 mg

10 mg

250 mL

5 mg

unit

4.98 mg

unit

5.11 mg

unit

50 mg

7 mg

10 mg

10 mg

EPY0000591 10 mg

Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 307

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Edition 2012/2013 Table of content

European Pharmacopoeia

Code Product Unit

EPY0000790 Vinpocetine impurity C ethyl(13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (methoxyvinpocetine)

Vinpocetine impurity D (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine)

Vinyl acetate

Voriconazole

Voriconazole impurity B (2RS,3SR)-2-(2,4-difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

Voriconazole impurity D (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (epi-voriconazole)

Voriconazole impurity E [(1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid ((+-)- camphorsulfonic acid)

Warfarin sodium

Warfarin sodium clathrate

Xylazine hydrochloride

Xylazine impurity C 2,6-dimethylphenyl isothiocyanate

Xylazine impurity E N-(2,6-dimethylphenyl)-S-methyldithiourea

Xylazine impurity mixture

Xylitol

Xylometazoline Hydrochloride

Xylometazoline impurity A N-(2-aminoethyl)-2-(4-1,1-dimethylethyl-2,6-dimethylphenyl)acetamide

Xylose

Yohimbine hydrochloride

Zidovudine

Zidovudine impurity A 1-[(2R,5S)-5-hydroxymethyl-2,5-dihydro-2-furyl]-5-methylpyrimidine-2,4(1H,3H)-dione

Zidovudine impurity B 1-(3-chloro-2,3-dideoxy-ß-D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione

Zinc acexamate

Zinc acexamate impurity A 6-[[6-(acetylamino)hexanoyl]amino] hexanoic acid

Ziprasidone for system suitability 1

Ziprasidone for system suitability 2

Ziprasidone hydrochloride monohydrate

Zolpidem tartrate Controlled Substance

Zolpidem impurity A N,N'-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazol [1,2-a]pyridin-3-yl] acetamide

Zopiclone Controlled Substance

Zopiclone oxide

Zuclopenthixol decanoate - Reference Spectrum

Zuclopenthixol for system suitability

Zuclopenthixol impurity B 2-chloro-9H-thioxanthen-9-one

10 mg

EPY0000760 10 mg

EPY0000793

New EPY0001395

New EPY0001396

New EPY0001398

200 mg

120 mg

10 mg

10 mg

New EPY0001397 50 mg

EPW0100000

EPY0000778

EPX0075000

EPY0000158

EPY0000159

EPY0001224

EPX0080000

EPX0100000

EPX0101000

EPX0200000

EPY0000656

EPZ1900000

EPZ1902000

EPZ1904000

EPZ2000000

EPZ2000010

EPY0001272

EPY0001241

EPY0001286

EPZ2500000

EPZ2500010

10 mg

10 mg

125 mg

50 mg

15 mg

0.02 mg

500 mg

100 mg

10 mg

100 mg

20 mg

60 mg

10 mg

10 mg

50 mg

50 mg

10 mg

0.465 mg

100 mg

200 mg

10 mg

EPZ3000000

EPZ3001000

EPY0000062

EPY0000534

EPY0000083

60 mg

20 mg

unit

0.1 mg

10 mg

308 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.