16
Name CAS Number Structure Product code 2-Methoxy-2-oxoethyl-{2-[(2, 6-dichlorophenyl)- amino] phenyl} acetate Synonym: Aceclofenac methyl ester 139272-66-5 ACPL-13-ACEC-01 [2-[(2,6-Dichlorophenyl) amino]phenyl] acetic acid Synonym: Aceclofenac Impurity A 15307-79-6 ACPL-13-ACEC-02 2-Ethoxy-2-oxoethyl-{2-[(2, 6-dichlorophenyl) amino]phenyl} acetate Synonym: Aceclofenac ethyl ester 139272-67-6 ACPL-13-ACEC-03 2-(Benzyloxy)-2-oxoethyl {2-[(2, 6-dichloro- phenyl) amino] phenyl} acetate Synonym: Aceclofenac benzyl ester; Aceclofenac Impurity F (EP) 100499-89-6 ACPL-13-ACEC-04 Cl Cl NH O O O O CH 3 Cl Cl NH OH O Cl Cl NH O O O O CH 3 Cl Cl NH O O O O

O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

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Page 1: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

Name CAS Number Structure Product code

2-Methoxy-2-oxoethyl-{2-[(2, 6-dichlorophenyl)-

amino] phenyl} acetate

Synonym: Aceclofenac methyl ester

139272-66-5 ACPL-13-ACEC-01

[2-[(2,6-Dichlorophenyl) amino]phenyl]

acetic acid

Synonym: Aceclofenac Impurity A

15307-79-6 ACPL-13-ACEC-02

2-Ethoxy-2-oxoethyl-{2-[(2, 6-dichlorophenyl)

amino]phenyl} acetate

Synonym: Aceclofenac ethyl ester

139272-67-6 ACPL-13-ACEC-03

2-(Benzyloxy)-2-oxoethyl {2-[(2, 6-dichloro-

phenyl) amino] phenyl} acetate

Synonym: Aceclofenac benzyl ester; Aceclofenac

Impurity F (EP)

100499-89-6 ACPL-13-ACEC-04

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

ClCl

NH

OO

O

O

CH3

ClCl

NH

OH

O

ClCl

NH

OO

O

O

CH3

ClCl

NH

OO

O

O

Page 2: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

4-(2-Chlorophenyl)-3-ethoxycarbonyl-5-

methoxycarbonyl-6-methyl-2-

(phthalimidoethoxy)methyl-1,4-dihydropyridine

Synonym: Amlodipine Impurity A (EP); Phthaloyl

Amlodipine

88150-62-3 ACPL-14-AMLO-01

3-Ethyl-5-methyl 2-[(2-aminoethoxy)methyl]4-(2-

chloro-phenyl)6-methyl pyridine-3,5-dicarboxylate

Synonym: Dehydro Amlodipine

113994-41-5 ACPL-14-AMLO-02

3-Ethyl-5-methyl 2-[(2-aminoethoxy)methyl]4-(2-

chloro-phenyl)6-methyl pyridine-3,5-dicarboxylate

oxalate

Synonym: Dehydro Amlodipine oxalate

1216406-90-4 ACPL-14-AMLO-03

3-Ethyl-5-methyl 4-(2-chloro-phenyl)-6-methyl-2[[-

(methylcarbamoyl)benzoyl] amino] ethoxy] methyl]-

1,4-dihydro-pyridine-3,5-dicarboxylate

Synonym: Amlodipine Impurity B (EP)

721958-72-1 ACPL-14-AMLO-04

3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-

[(2-carboxybenzoyl)amino ethoxy)]methyl]-1,4-

dihydopyridine-3,5-dicarboxylate

Synonym: 2-Carboxybenzoyl Amlodipine

318465-73-5 ACPL-14-AMLO-05

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

Cl

NH

H3COOC

H3C

O CH3

O

ON

O

O

Cl

N

H3COOC

H3C

O CH3

O

ONH2

Cl

N

H3COOC

H3C

O CH3

O

ONH2

COOH

COOH

Cl

NH

H3COOC

H3C

O CH3

O

ONH

O

H3CHN

O

NH

H3C

H3COOC

Cl

O CH3

O

O

NH

OOHO

Page 3: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

Dimethyl-4-(2-chlorophenyl)-2,6-dimethyl-1,4

dihydropyridine-3,5-dicarboxylate

Synonym: Amlodipine Impurity G (EP)

43067-01-2 ACPL-14-AMLO-06

(2S-cis)-(−)-5-Benzyl-3,6-dioxo-2-piperazineacetic

acid

Synonym: Aspartame Impurity A

5262-10-2 ACPL-01-ASPA-01

L-α-Aspartyl-L-phenylalanine

Synonym: Aspartame Impurity B13433-09-5 ACPL-01-ASPA-02

2-(4-Hydroxyphenyl) acetamide

Synonym: Atenolol Impurity A (EP)17194-82-0 ACPL-15-ATEN-01

2-[4-(2,3-Dihydroxy propoxy)phenyl] acetamide

Synonym: Atenolol Impurity B61698-76-8 ACPL-15-ATEN-02

2-[4-(Oxiran-2-yl methoxy)phenyl] acetamide

Synonym: Atenolol Impurity C29122-69-8 ACPL-15-ATEN-03

2-[4-(3-Chloro-2-hydroxy propoxy)phenyl]

acetamide

Synonym: Atenolol Impurity D

115538-83-5 ACPL-15-ATEN-04

2,2’-**(1-Methylethyl)- imino+bis*(2-hydroxy-

propane-3,1-diyl)oxy-4,1-phenyl-ene]]diacetamide

Synonym: Atenolol Impurity F(EP)

87619-83-8 ACPL-15-ATEN-05

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

OH

H2N

O

O

H2N

OOH

OH

O

H2N

O

O

O

H2N

OCl

OH

H2N

ON

O

OH

O

H3C CH3

OH

NH2

O

Cl

NH

H3COOC

H3C

OCH3

O

CH3

HO

OHN

O

O

OH

NH2

Page 4: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

{4-[2-Hydroxy-3-(propan-2-ylamino)-

propoxy]phenyl} acetic acid

Synonym: Atenolol Impurity G

56392-14-4 ACPL-15-ATEN-06

{4-[2-Hydroxy-3-(propan-2-ylamino)propoxy]-

phenyl} acetonitrile

Synonym: Atenolol Impurity H

29277-73-4 ACPL-15-ATEN-07

2-{4-[3-(Ethylamino)-2-hydroxy propoxy]-

phenyl}acetamide

Synonym: Atenolol Impurity I

NA ACPL-15-ATEN-08

(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-

3,5-dihydroxyheptanoic acid

Synonym: Atorvastatin free base

134523-00-5 ACPL-04-ATOR-01

(3R,5R)-7-[2,3-diphenyl-4-(phenylcarbamoyl)-5-

propan-2-yl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic

acid

Synonym: Desfluoro Atorvastatin (Impurity A)

433289-83-9 ACPL-04-ATOR-02

(3S,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-

3,5-dihydroxyheptanoic acid

Synonym: Atorvastatin diastereomer (3S, 5R)

(Impurity B)

887196-25-0 ACPL-04-ATOR-03

(3R,5R)-7-[2,3-bis(4-fluorophenyl)-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-

3,5-dihydroxyheptanoic acid

Synonym: Fuloroatorvastatin (Impurity C)

693793-53-2 ACPL-04-ATOR-04

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

N OH

OOHOH

NH

O

F

N OH

OOHOHNH

O

N OH

OOHOHNH

O

F

N OH

OOHOHNH

O

F

F

HOOC

O

HN

H3C CH3

OH

NC

ONH

OH

H3C CH3

O

HN

CH3

OH

H2N

O

Page 5: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

3-[(4-Fluorophenyl)carbonyl]-2-(2-

methylpropanoyl)-N-3-diphenyloxirane-2-

carboxamide

Synonym: Atorvastatin Impurity D

148146-51-4 ACPL-04-ATOR-05

(3S,5S)-7-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-

3,5-dihydroxyheptanoic acid

Synonym: Entatorvastatin (Impurity E)

1105067-88-6 ACPL-04-ATOR-06

(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-5-

hydroxy-3-methoxyheptanoic acid

Synonym: 3-O-Methyl Atorvastatin (Impurity G)

887196-29-4 ACPL-04-ATOR-07

(4R,6R)-6-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-

ylethyl]-4-hydroxytetrahydro-2H-pyran-2-one

Synonym: Atorvastatin Lactone (Impurity H)

125995-03-1 ACPL-04-ATOR-08

(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-

3,5-dihydroxyheptanoic acid methyl ester

Synonym: Atorvastatin Methyl ester

345891-62-5 ACPL-04-ATOR-09

(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-

(phenylcarbamoyl)-5-propan-2-yl-1H-pyrrol-1-yl]-

3,5-dihydroxyheptanoic acid methyl ester

Synonym: Atorvastatin Ethyl ester

1146977-93-6 ACPL-04-ATOR-10

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

O

O

NH

O O

F

N OH

OOHOHNH

O

F

N OH

OOOHNH

O

F

N

ONH

O

F

O

OH

N O

OOHOH

NH

O

F

N O

OOHOHNH

O

F

Page 6: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

5-(4-Fluorophenyl)-1-{2-[(2R,4R)-4,5-dehydro-xy-6-

oxodihydro-2H-pyran-2-yl]ethyl}-2-isopropyl-N,4-

diphenyl-1H-pyrrole-3-carboxamide

Synonym: Atorvastatin dehydrolactone

442851-50-5 ACPL-04-ATOR-11

1-[4-(Hydroxymethyl)-phenoxy]-3-(propan-2-

ylamino)propan-2-ol

Synonym: Des(isopropoxyethyl) Bisoprolol

62572-93-4 ACPL-11-BISO-01

2-(Propan-2-yloxy)ethyl 4-{2-hydroxy-3-[(propan-2-

yl)-amino]propoxy}benzoate

Synonym: Keto Bisoprolol

864544-37-6 ACPL-11-BISO-02

1-(4-Methylphenoxy)-3-(propan-2-ylamino)-

propan-2-ol

Synonym: 1-(Isopropylamino)-3-(4-

methylphenoxy)-2-propanol

NA ACPL-11-BISO-03

4-[2-Hydroxy-3-(propan-2-ylamino)-propoxy]

benzoic acid hydrochloride

Synonym: 4-(2-Hydroxy-3-

isopropylaminopropoxy)benzoic Acid

72570-70-8 ACPL-11-BISO-04

4-[5-(3-Methylphenyl)-3-trifluoromethyl-1H-

pyrazol-1-yl]benzenesulfonamide

Synonym: 4-Desmethyl-3-methyl Celecoxib

170570-01-1 ACPL-16-CELE-01

4-[3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-

pyrazol-1-yl]benzenesulfonamide

Synonym: Celecoxib Impurity B

331943-04-5 ACPL-16-CELE-02

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

N

ONH

O

F

O

OH

O

HO

HN

CH3

H3C

O

HO

HN

CH3

H3C

HOOC O OH

HN

CH3

CH3

NN

CF3

SH2N

OO

Page 7: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

4-[N'-(1-p-tolylethylidene)-hydrazino]-benzene-

sulfonamide

Synonym: Celecoxib Impurity F

NA ACPL-16-CELE-03

4-{5-[4-(Hydroxymethyl)-phenyl]-3-(trifluoro-

methyl)-1H-pyrazol-1yl}benzenesulfonamide

Synonym: Hydroxymethyl celecoxib

170571-00-3 ACPL-16-CELE-04

4,4,4,-Trifluoro-1-(p-tolyl)-butane-1,3-dione

Synonym: 1-(4-Methylphenyl)-4,4,4-trifluoro-

butane-1,3-dione

720-94-5 ACPL-16-CELE-05

4-Sulfonamidophenylhydrazine hydrochloride

Synonym: 4-Hydrazinobenzene-1-sulfonamide

hydrochloride

17852-52-7 ACPL-16-CELE-06

5-p-Tolyl-3-trifluoromethyl-1H-pyrazole 948293-46-7 ACPL-16-CELE-07

4-[1-[4-(Aminosulfonyl)phenyl]-3-(trifluoromethyl)-

1H-pyrazol-5-yl]benzoic acid

Synonym: Celecoxib Carboxylic acid

170571-01-4 ACPL-16-CELE-08

4-[5-(2-Methylphenyl)-3-trifluoromethyl-1H-

pyrazol-1-yl]benzenesulfonamide

Synonym: 4-Desmethyl-2-methyl Celecoxib

170569-99-0 ACPL-16-CELE-09

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

OH

N

N

CF3

SO2NH2

CF3

CH3

O O

S

NH2

NH

OO

NH2

ClH

NHNCF3

Page 8: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

(RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine

Synonym: Cetrizine Impurity A303-26-4 ACPL-18-CETRI-01

1,4-bis[(4-Chlorophenyl)phenyl methyl]piperazine

dihydrochloride

Synonym: Cetrizine Impurity D

346451-15-8 ACPL-18-CETRI-02

(S)-N-[1-(1-Naphthyl)ethyl]-3-[3-

(trifluoromethyl)phenyl]propan-1-amine

Synonym: Cinacalcet S-isomer

NA ACPL-08-CINA-01

1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-

1,3-dihydro-2-benzofuran-5-carboxamide

Synonym: Citalopram Impurity A

64372-56-1 ACPL-19-CITAL-01

3-[3-(Dimethyamino)propyl]-1-(4-fluoro-phenyl)-3-

hydroxy-1,3-dihydroisobenzofuran-

5-carbonitrile

Synonym: 3-Hydroxy Citalopram

411221-53-9 ACPL-19-CITAL-02

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

HN

CF3

N

NHCl

N

N

Cl

Cl

.HCl

.HCl

O

F

N

H3C CH3

O

H2N

O

NC

HO

F

N

Page 9: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-

1,3-dihydro-3-oxo- 5-isobenzofurancarbonitrile

Synonym: 3-Oxo Citalopram

372941-54-3 ACPL-19-CITAL-03

1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-

1,3-dihydro-2-benzofuran-5-carbonitrile

Synonym: Citalopram Impurity D

144025-14-9 ACPL-19-CITAL-04

(S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-

c]pyridin-5(4H)-yl)acetic acid

Synonym: Clopidogrel impurity A

NA ACPL-05-CLOP-01

Methyl (-)-(R)-2-(2-chlorophenyl)-2-(6,7-

dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate

bisulphate

Synonym: Clopidogrel Impurity C

NA ACPL-05-CLOP-02

ent-3-Methoxymorphinan

Synonym: Dextromethorphan Impurity A 1531-25-5 ACPL-20-DEXT-01

ent-17-Methylmorphinan 3-ol

Synonym: Dextromethorphan Impurity B

1021868-94-9

(tartarate) ACPL-20-DEXT-02

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

N

O OH

SCl

N

O O

SCl

.2H2SO4

O

NC

NH

CH3

F

O

NC

O

F

N

OH

N

H

OCH3

HN

H

Page 10: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

ent-3-Methoxy-17-methylmorphinan-10-one

Synonym: Dextromethorphan Impurity C 57969-05-8 ACPL-20-DEXT-03

(9S,13S,14S)-3-Methoxy-17-methylmorphinan 17-

oxide hydrochloride

Synonym: Dextromethorphan N-oxide210690-24-7 ACPL-20-DEXT-04

7-Chloro-5-phenyl-1,3-dihydro-2H-1,4-Benzo-

diazepin-2-one

Synonym: Desmethyldiazapam; Nordazepam

1088-11-5 ACPL-21-DIAZ-01

2-Chloro-N-(4-chloro-benzoylphenyl)-N-

methylacetamide

Synonym: Diazepam Impurity B

6021-21-2 ACPL-21-DIAZ-02

3-Amino-6-chloro-1-methyl-4-phenyl-

quinolin-2(1H)-one

Synonym: Diazepam Related Compound B

5220-02-0 ACPL-21-DIAZ-03

[5-Chloro-2-(methylamino)benzophenone

Synonym: Diazepam Impurity D(EP); Diazepam

Related Compound A

1022-13-5 ACPL-21-DIAZ-04

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

OCH3

N

H

H3C

OHCl

OCH3

N

H

H3C

O

Cl

ONCl

O

Page 11: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

6-Chloro-1-methyl-4-phenylquinazolin-

2(1H)-one

Synonym: Diazepam Impurity E

20927-53-1 ACPL-21-DIAZ-05

7-Chloro-2-methoxy-5-phenyl-3H-1,4-

benzodiazepine

Synonym: Diazepam Impurity F(BP)

31269-33-7 ACPL-21-DIAZ-06

1-(2, 6-Dichlorophenyl)-1, 3-dihydro-

2H-indol-2-one

Synonym: Dichlofenac Amide

15362-40-0 ACPL-22-DICLO-01

Ethyl{2-[(2,6-dichloro phenyl)amino]

phenyl} acetate

Synonym: Dichlofenac Ethyl Ester

15307-77-4 ACPL-22-DICLO-02

1,3-Dihydro-2H-indol-2-one

Synonym: 2-Oxindole; Dichlofenac Impurity E(EP) 59-48-3 ACPL-22-DICLO-03

Propan-2-yl{2-[(2,6-dichloro phenyl)-amino]

phenyl} acetate

Synonym: Dichlofenac Isopropyl Ester

66370-79-4 ACPL-22-DICLO-04

Methyl {2-[(2,6-dichloro-phenyl) amino]-

phenyl} acetate

Synonym: Dichlofenac Methyl Ester

15307-78-5 ACPL-22-DICLO-05

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

N

NOCH3

Cl

NHO

O

ClCl

CH3

N

O

Cl Cl

NH

O

NHO

O

ClCl

CH3

CH3

NHO

O

ClCl

CH3

Page 12: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

Diethyl benzene-1,2-dicarboxylate 84-66-2 ACPL-22-DICLO-06

2,6-Dichloroaniline 608-31-1 ACPL-22-DICLO-07

3-(Methylamino)-2,3,4,9-tetrahydro-1H-carbazole-

7-carboxamide

Synonym: rac-6-Deaminocarbonyl-Frovatriptan-7-

carboxamide]

NA ACPL-12-FROVA-04

3-Carboxamidophenyl hydrazine hydrochloride

Synonym: 3-Hydrazinobenzamide hydrochloride

473927-51-4 (of

free hydrazine)ACPL-12-FROVA-05

4-Carboxamidophenyl hydrazine hydrochloride

Synonym: 4-Hydrazinobenzamide hydrochloride

74885-67-9 (of

free hydrazine)ACPL-12-FROVA-06

3,3-Dimethyl-1,5-dioxaspiro[5.5]undecan-9-one

Synonym: 1,4-Cyclohexanedione mono(2,2-

dimethyltrimethylene Ketal)

69225-59-8 ACPL-12-FROVA-07

3,3,12,12-Tetramethyl-1,5,10,14-

tetraoxadispiro[5.2.5.2]hexadecane

Synonym: 1,4-Cyclohexanedione bis(2,2-

dimethyltrimethylene Ketal)

29280-23-7 ACPL-12-FROVA-08

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

NHNH2.HCl

CONH2

NH

NH

H2N

O

NHNH2.HCl

O

H2N

O

O

O

O

O

O

O

O CH3

O CH3

O

O

NH2

ClCl

Page 13: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

3-(Dimethylamino)-2,3,4,9-tetrahydro-1H-

carbazole-6-carboxamideNA ACPL-12-FROVA-09

N,N,3,3-Tetramethyl-1,5-dioxaspiro[5.5]undecan-9-

amine hydrochloride

107431-14-1 (of

free amine)ACPL-12-FROVA-10

3-(Methylamino)-2,3,4,9-tetrahydro-1H-carbazole-

6-carboxylic acidNA ACPL-12-FROVA-11

Propan-2-yl-(7,7-Dimethyl-1,3-

Oxobicyclo[2,2,1]hept-1-yl)methanesulfonateNA ACPL-12-FROVA-12

3,3-Dimethyl-9-(methylamino)-1,5-

dioxaspiro[5.5]undecane hydrochloride

Synonym: (4-Methylamino)cyclohexanone 2,2-

dimethyltrimethylene ketal hydrochloride

158747-10-5 ACPL-12-FROVA-13

3-Amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-5(4H)-

one

Synonym: Lamotrigine Impurity A

NA ACPL-07-LAMO-01

2-(2,3-Dichlorophenyl)-guanidinoimino acetonitrile

Synonym: Lamotrigine Impurity BNA ACPL-07-LAMO-02

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

NH

NO

H2N

O

O

N .HCl

NH

NHO

HO

OSO

OO

O

O

NH.HCl

HN

N N

H2N

Cl ClO

Cl Cl

NC

NNH

NH

H2N

Page 14: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

Prasugrel hydrochloride 389574-19-0 ACPL-10-PRASU.HCl

1-Cyclopropyl-2-(2-fluorophenyl)-2-(3a,6,7,7a-

tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)ethanoneNA ACPL-10-PRASU-01

5-(Triphenylmethyl)-3aH,4H,5H,6H,7H,7aH-

thieno[3,2-c]pyridineNA ACPL-10-PRASU-02

5-(Triphenylmethyl)-5,6,7,7a-tetrahydrothieno[3,2-

c]pyridin-2(4H)-one109904-26-9 ACPL-10-PRASU-03

2,2-Dibromo-l-cyclopropyl-2-(2-

fluorophenyl)ethanoneNA ACPL-10-PRASU-04

5-[5-Bromo-1-(2-fluorophenyl)-2-oxopentyl]-

4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetateNA ACPL-10-PRASU-05

1-Cyclopropyl-2-(2-fluorophenyl)-2-

hydroxyethanone1100905-45-0 ACPL-10-PRASU-06

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

F

NO

S

N

S

N

SO

FO

Br Br

N

OBr

SO

O

F

FO

OH

N

O

SO

O

FH

.HCl

Page 15: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

1-Cyclopropyl-2-(2-fluorophenyl)ethan-1,2-dione NA ACPL-10-PRASU-07

1, 5-Dibromo-1-(2-fluorophenyl)pentan-2-one 1373350-57-2 ACPL-10-PRASU-08

5-[5-Chloro-1-(2-fluorophenyl)-2-oxopentyl]-4,5,6,7-

tetrahydrothieno[3,2-c]pyridin-2-yl acetate [Ring

opened degradant]

NA ACPL-10-PRASU-10

5-[5-Bromo-1-(2-fluorophenyl)-2-oxopentyl]-

4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2(3H)-oneNA ACPL-10-PRASU-11

5-[1-(2-Fluorophenyl)-2-oxopropyl]-4,5,6,7-

tetrahydrothieno[3,2-c]pyridin-2-yl acetateNA ACPL-10-PRASU-12

5-(2-Cyclopropyl-2-oxo-1-phenylethyl)-4,5,6,7-

tetrahydrothieno[3,2-c]pyridin-2-yl acetate

Synonym: Prasugrel Desfluoro Impurity

NA ACPL-10-PRASU-14

5-(2-Cyclopropyl-1-(4-fluorophenyl)-2-oxoethyl)-

4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate

Synonym: Prasugrel 4-fluoro Impurity

NA ACPL-10-PRASU-15

5-(α-Cyclopropylcarbonyl-2-fluorobenzyl)-2-oxo-

2,4,5,6,7,7a hexahydrothieno [3,2-c]-pyridine

Synonym: Prasugrel Desacetyl Impurity

NA ACPL-10-PRASU-16

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

FO

O

FO

Br

Br

N

OCl

SO

O

F

N

OBr

SO

F

N

O

SO

O

F

N

O

SO

O

F

O

F

N

SO

Page 16: O C H NH Name CAS Number Structure Product code C l C l O Cl C l O NH C H … · 2015-06-27 · Synonym: Amlodipine Impurity B (EP) 721958-72-1 ACPL-14-AMLO-04 3-Ethyl-5-methyl-4-(2-chloro-phenyl)-6-methyl-2-[2-[(2-carboxybenzoyl)amino

1-Cyclopropyl-2-(2-fluorophenyl)-2-(6,7-

dihydrothieno[3,2-c]pyridin-5(4H)-yl)ethanone

hydrochloride

Synonym: Prasugrel Desoxo Impurity

NA ACPL-10-PRASU-17

2-[(4-(3-Methoxypropoxy)-3-methylpyridin-2-

yl)methylsulfonyl]-1H-benzo[d]imidazole

Synonym: Rabeprazole sulfone impurity

NA ACPL-06-RABE-01

2-[(4-(3-Methoxypropoxy)-3-methyl-1-oxido-2-

pyridinyl)methylsulfonyl]-1H-benzo[d]imidazole

Synonym: Rabeprazole sulfone N-oxide

NA ACPL-06-RABE-02

2-[(4-(3-methoxypropoxy)-3-methyl-1-oxido-2-

pyridinyl)methylthio]-1H-benzo[d]imidazole

Synonym: Rabeprazole sulphide impurity

NA ACPL-06-RABE-03

2,2-Dimethylbutanoic acid (1S,3R,7S,8S,8aR)-8-[2-

[(2R)-3,6-dihydro-6-oxo-2H-pyran-2-yl]ethyl]-1,2-

3,7,8,8a-hexahydro-3,7-dimethyl-1-naphthalenyl

ester

Synonym: Simvastatin Impurity C

NA ACPL-09-SIMVA-03

N

O

SO

O

N

O

S

F .HCl

OO CH3

ONH

H3C

O

CH3

OH

CH3

H2NO2S

N N

CH3

F3C

N

HN

SO2NH2

CH3

H3C

HOOC

NN

H2NO2S

CF3

CH3

N

N

CF3

SO2NH2

N

HN

Cl

O

N

CH3

O

NH2Cl

NHH3C

O

Cl

N

N

CH3

O

Cl

NH

N SN

O O

O O

NH

N SN

O O

O O

O

NH

N SN

O O

O

H3C

CH3

O

O

H3C

O

CH3H3C