A4 PHARMA CATALOG - Copy · 2020. 11. 18. · Impurity : Individual impurity Any other unspeciied Impurity Total Impurity Impurity Assay NMT 0.5% FOR Fenoibrate related compound B

PHARMADIVISION

GASTROINTESTINAL

ANTI-OBESITY

NEUROLOGICAL

ANTI-DEPRESSANT

CARDIOVASCULAR

UROLOGICAL

ANTI-INFECTIVE

DIGESTIVEENZYME

NEUTRALPELLETS

ANTI-INFLAMMATORY

1-5

6

7

12

14-15

17-18

19-22

ENDICRINOLOGY

RESPIRATORY

23-25

13

16

16

8-9

10-11

MOUTHDISSOLVINGFILMS

VITAMINS&MINERALS

26

E IN NCAPSULAT O

products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries. 2

GASTROINTESTINALDRUGPELLETS

OMEPRAZOLEECMUPS

USP

Medium:0.1Nhydrochloricacid;500mlRPM:100

Apparatus:2

Time:2Hours

Medium:PhosphateBuffer;900mlpH7.6

Dissolution

>85%-

NMT15%

NMT75%(Q)

ofLAofOmeprazole

ofLAofOmeprazole

USPAssay 90TO110% ofLAof

Omeprazole

Dissolved

Dissolved

CompliesbyHPLC

NMT5%

USP

USP

USP

USP

Identi�ication:

LossonDrying

Availablesizes:

PhysicochemicalTests

ParticleSizeDistribution

RPM:100Apparatus:2

AvailablePercentage: 8.5%,20%,22.22%

Appearances IHstandardHard, brittle, free �lowing,spherical masses

BulkDensityNLT0.5gm/cc

14-20#,30-60#

ESOMEPRAZOLEMAGNESIUMDRMUPS

AvailablePercentage: 8.5%,11%,22.5%

Appearances IHstandardHard, brittle, free �lowing,spherical masses

>85%- USP

Medium:0.1Nhydrochloricacid;300mlRPM:100Apparatus:Paddle

Time:2Hours

Medium:PhosphateBuffer;700ml

Impurities NMT (%)

Omeprazole-OmeprazoleSulfonea 0.5

Anyotherindividualimpurity0.2Totalimpurities 2

NLT10%(Q)

NLT80%(Q)

ofLAofEsomeprazole

ofLAofEsomeprazole

Dissolved

Dissolved

ComplybyHPLCDissolution:

NMT5%USP

USP

USP

USP

USP

Identi�ication:A

LossondryingBulk DensityNLT0.6gm/cc

Availablesizes:



RPM:100Apparatus:Paddle

Time:30min

USPAssay 90TO110% ofLAofEsomeprazole

14-20#,30-60#


3

PANTOPRAZOLESODIUMDRMUPS

AvailablePercentage:15%,20%

Appearances IHstandardHard, brittle, free �lowing ,spherical masses

>85%-

Medium:0.1Nhydrochloricacid;1000mlRPM:75Apparatus:2Time:120minMedium:PhosphateBuffer;pH6.81000ml

Impurities NMT(%)

Pantaprazole

Anyotherindividualimpurities0.21.0

0.5C

0.50.3

Totalimpurities

-

Assay

NLT10%

NLT75%(Q)

ofLAofPantoprazole

ofLAofPantoprazole

90TO110% ofLAof

Pantoprazole

Dissolved

Dissolved

Dissolution:NMT5%

USP

USP

USP

USP

USP

Losson ryingDBulkDensityNLT0.6gm/cc

Availablesizes:



Identi�ication Shall Comply byHPLC

RPM:75Apparatus:2Time:30min

relatedcompoundsDaandfb

PantaoprazolerelatedcompoundBePantaoprazolerelatedcompoundAd

14-20#,30-60#

LANSOPRAZOLEMUPS

AvailablePercentage:8.5%,12.5%,15%

Appearances IHstandardHard, brittle, free �lowing ,spherical masses

>85%

90TO110%

NMT0.5gm/cc

NMT5%

USP

Medium:0.1Nhydrochloricacid;500mlRPM:75Apparatus:2Time:60min

Medium:PhosphateBuffer;PH6.8900ml

Impurities NMT(%)LansoprazoleN-oxide

LansoprazolerelatecompoundA(Lansoprazolesulfone)

0.4

0.1

Assay

NMT10%

NLT80%(Q)

ofLAofLansoprazole

ofLAofLansoprazole

ofLAofLansoprazole

Dissolved

Dissolved

CompliesbyUV

Dissolution:

USP

USP

USP

USP

USP

Identi�ication:A

Identi�ication:BComplies byHPLC

Lossondrying

BulkDensity

Availablesizes:14-20#,30-60#



RPM:75Apparatus:2

Time:60min

-

products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.


4

MESALAMINEERPELLETS

85%>- USP

14-20#

AvailablePercentage: 90%,96.38%

1hr=between5%and25%

2hrs=between30%and50%

4hrs=between60%and90%

8hrsnotlessthan85%

Assay 90TO110% USP

USP

ofLAofMesalamine%

CompliesbyIR

Medium:0.05MPhosphateBuffer

Identi�ication

LossonDrying

BulkDensity


RPM:100

Apparatus:2

Time:1,2,4,8HOURS

pH:7.5

Dissolution

NMT5% USP

USP

USP

Appearances

NLT5gm/cc

Availablesizes:


IHstandardHard,brittle,free�lowing,sphericalmasses

DEXLANSAPRAZOLEERPELLETS

AvailablePercentage: 17%,20%,22.5%DDR

Appearances




Identi�ication CompliesbyHPLC

LossOnDrying NMT5.0%

Bulk Density NMT0.5gm/cc

Dissolution

NMT10%oflabeledclaimofdrugreleasedin1Hrs.

NLT80%oflabeledclaimofdrugreleasedin1Hrs

ResidualSolventsNMT5000ppmNMT600ppm

Assay


Medium:0.1Nhydrochloricacid;500mlRPM:75Apparatus:2Time:60min

Medium: Phosphate Buffer;PH6.8900ml

RPM:75Apparatus:2

IsopropylalcoholMethylenedichloride

Time:60min

90TO110% ofLAofDexlansaprazole

USP

USP

USP

USP

USP

>85%-

Itopridepellets

Linaclotidepellets 0.09%,0.25%

60%

AVAILABLEDRUGPELLETS

DrugPellets(IR/ER/SR) %



5

MEBEVERINEHCLSRPELLETS

Physicochemical

Hard,brittle,free�lowing,whitecoloursphericalmasses

Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication complybyHPLC>85%- USP

BulkDensity NLT0.5gm/cc USPUSP

USP

USP

USP


AvailablePercentage:55%,60%,80%

AvailableSizes:14-20#

Dissolution:

Medium1:0.1NHCL

Medium2:pH6.8Buffer

900ml

Time: 1

3

8Hr

RPM:100Apparatus:paddle

USPLossOnDrying NMT5.0%

USPResidualorganicsolvents

OrganicImpurities

NMT0.5%Individual impurities

Total impurities NMT1.0%

IPA-NMT5000PPMMDC-NMT500PPM

After1Hr-10%-30%

After3Hr-30%-60%

After8Hr-NLT70%

MicropbialLimitTest

Totalaerobic microbualcountNMT100cfu/gmTotal yeast &mould countNMT 10cfu/gmEscherichia coliAbsent in1gm

Salmonella Absent in10gm

RABEPRAZOLEECPELLETS

Physiochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication:A complybyHPLC

>85%- USP

BulkDensity NLT0.5gm/cc USP

USP

USP

USP


AvailablePercentage:55%,60%,80%

AvailableSizes:14-20#

Dissolution:


Medium:0.1Nhydrochloride

acid;500ml

Time: 60min

RPM:75Apparatus:2

NMT10%ofL.Aof

Rabeprazole

Medium:PhosphateBuffer

pH6.8;900ml

Time:60min

Assay 90.0 to110.0ofLaamount of

Rabeprazole

RPM:75Apparatus:2

NLT70%ofL.Aof

Rabeprazole


ANTI-OBESITYDRUGPELLETS

6

RELEASE CONTROL POLYMER

DRUG LAYER

CORE GRANULES

PROTECTIVE COATINGADDITIONAL CONTROL POLYMER

ORLISTATDRUGPELLETS

>85%-

AvailablePercentage:

Medium:3%Sodiumlaurylsulfateand0.5%sodiumchlorideinwater(pH6.0);900ml


orlistatopenringepimer1.5orlistatopenringb

b

d

a

0.3orlistatrelatedcompoundD1.0Hexylundecylpyranone0.2

Henicosenylleucinate0.3

Anyotheridenti�ied impurity

0.3

Totalimpurities3.0Individualunidenti�iedimpurity0.2

Assay

50%,60%

NLT75%(Q) ofLAoforlistatDissolved

CompliesbyHPLC

Dissolution:

NMT5% USP

USP

USP

USP

USP

Identi�ication

Appearances

LossonDryingBulkDensityNLT5gm/cc

Availablesizes:




Impurities

NMT(%)

USP90TO110% ofLAofOrlistat

14-20#

FENOFIBRATEIRPELLET

Physicochemical

Hard,brittle,free�lowing,whitecoloursphericalmassesAppearances IHStandard

Identi�ication:A

Identi�ication:B

complybyHPLC

complybyUV

BulkDensity NLT0.5gm/cc

>85%- USP

USP

USP

USP

USP

USP

USP

USP

USP

ParticlesizeDistribution

Dissolution

Medium:0.05Msodiumlaurylsulfateinwater

1000ml

Time:40min

Impurity:

Individualimpurity

Anyotherunspeci�ied

Impurity

TotalImpurity

Impurity

Assay

NMT0.5%FORFeno�ibraterelatedcompoundB

NMT0.2%

NMT2.0%

RPM:75Apparatus:2

LossOnDrying NMT5.0

90TO110% ofLAofFeno�ibrate

NLT70%ofLAofamountFeno�ibratedissolved

AvailablePercentage:50%,66.23%,75%SR

Availablesizes:14-20#

Feno�ibricAcidDR 29%

Cholinefeno�ibratepellets 60%




7

ANTI-DEPRESSANTDRUGPELLETS

VENLAFAXINEHYDROCHLORIDEERPELLETS

>85%

90TO110%

- USP

USP

Medium:Water;900ml

RPM:100Apparatus:1

Time:3hrs6hrs35%-60%16hrs60%-85%24hrsNLT75%

NMT 40%

Impurity:

IndividualImpurityNMT0.2%TotalImpurityNMT0.5%Assay ofLAofVenlafaxine

Hydrochloride

Dissolution

NMT5% USP

USP

USP

USPUSP

CompliesbyUVIdenti�ication:A

CompliesbyHPLCIdenti�ication:B

LossonDrying





AvailablePercentage: 33%

Appearances IHstandardHard,brittle,free�lowing,sphericalmasses

Sertralinepellets 25%,50%



DULOXETINEDRPELLETS

USP

a-Naphthol

Anyindividualunspeci�ieddegradationproduct

NMT0.2%NMT0.2%0.2%

Impurities

AssayTotal impurities

CompliesbyIRCompliesbyHPLC

Dissolution:

NMT5% USP

USP

USP

USP

Identi�ication:AIdenti�ication:B

LossondryingBulkDensityNLT5gm/cc




AvailablePercentage:9%,14.85%,17%,17.65%,22.5%


Medium:water1000mlsolution;1000mlRPM:100Apparatus:1Detector:UV232mmTime:2hours

USP

NLT10%ofLAofDuloxetineDissolved

Medium: pH6.8Phophate Buffer1000mlRPM:100Apparatus:1Detector:UV232nmTime:90min

NLT75%(Q)ofLAofDuloxetineDissolved

Duloxetinerelated compoundHC

NMT0.4%90TO110% ofLAof Duloxetine

>85%-


DICLOFENACSODIUMERPELLETS

90TO110%

>85%-USP

USP


Medium:0.05MPhosphate

Buffer pH7.5;900ml

RPM:50

Apparatus:2

Time: 1hrs5hrs45%-65%

10 hrs65%-85%75%-95%16

24hrshrsNLT80%

15%-35%

Assay

33%,37%,40%,52%

ofLAofDiclofenac sodium

Dissolution:

USP

USP

CompliesbyHPLC

CompliesbyTLC

USP

USP

Identi�ication:A

Identi�ication:B

Appearances






8

ASPIRINDRPELLETS

>85%- USP

USP

Medium: Buffer pH6.8;

Impuritieslimit offree salicylic acidNMT3%

RPM:100

RPM:100

Apparatus:1

Apparatus:1

Time:90min

Time:90min

Analyticalwavelength;280mm

Analyticalwavelength;265mm

Assay

NMT10%

NLT75%(Q)

ofLAofAspirin

ofLAofAspirin

93.0TO107% ofLAofAspirin

Dissolved

Dissolved

Dissolution:

USP

USP

USP

ShallComplybyHPLC

ShallComplybyIR

USP

USP

Identi�ication:A

Identi�ication:B

Bulk DensityNLT0.5gm/cc

LossonDryingNMT0.5




AvailablePercentage: 50%,65%


ANTI-INFLAMMATORYDRUGPELLET

Medium: 0.1Nhydrochloride

and0.2Mtribasicsodiumphosphate(3:1500ml)


9

ANTI-INFLAMMATORYDRUGPELLET

IBUPROFENDRUGPELLET

>85%


Appearances



BulkDensity

Water

Identi�ication:AParticleSizeDistribution

Identi�ication:B

Medium:phosphatebufferpH7.2,700ml


ShallcomplybyUV

ShallcomplybyHPLC

NLT0.5gm/cc

NMT5%

RPM:50

Apparatus:2

Time:60min complybyUV

NLT80%(Q)ofLAofIbuprofen

Assay 93.0TO107% ofLAofIbuprofen

Dissolved

Dissolution:

USPUSP

USP

USP

USP

USP

USP

-

KETOPROFENSRPELLET

AvailablePercentage: 60%,65%,70%

Appearances

AvailableSizes:14-20#,30-60#


ParticlesizeDistributionIdenti�ication:A

Identi�ication:B

BulkDensity

LossinDrying

Dissolution


ShallcomplybyHPLC

ShallcomplybyUV

NLT0.5gm/cc

NMT5.0%

Medium: PhosphateBuffersolution;1000ml

RPM:50

Apparatus:2Detector:UV258mmTime: 110-25%

55-80%4

8HrNLT80%

NLT80%(Q)ofLAofKetoprofen

Assay 90TO110% ofLAofKetoprofen

Dissolved

USPUSP

USP

USP

USP

USP

USP

>85%-

6.8

DimethyleFumaratePellets

IndomethacinPellets

FlurbiprofenSRPellets

BudesonideECPellets

DiclofenacpottasiumEC

Nimusulide

PiroxicamPellets

27%

60%

0.9%

50%

48%

0.02%

CalecoxibPellets 55%

50%




CARDIOVASCULARDRUGPELLETS

90TO110%

>85%- USP

USP


Assay

1.236%,1.73%,2.04%,2.5%

ofLAof

Nitroglycerin

Medium:WaterDissolution:

USP

CompliesbyHPLC USPIdenti�ication:A

Appearances

USPLossonDryingNMT5%

Bulk Density0.8 - 0.9gm/cc





RPM:120Apparatus:2Time: 25% to50%

60% to90%NLT80%

1hr4hr8hr12hr NLT85%

NITROGLYCERINSRPELLETS

10

NIFEDIPINEERPELLETS

>85%- USP

USP


Medium:1.25%Sodiumlauryl

sulfateinwater900ml

RPM:100Apparatus:2Time:1hrs

2hrs15%-40%4hrs 35%-70%

10hrs NLT85%

NMT25%

Assay

8.6%,17.14%

90TO110% ofLAof

Nifedipine

Dissolution:

USP

USP

CompliesbyHPLCCompliesbyUV

USPUSP

Identi�ication:A

Identi�ication:B

Appearances

Loss on DryingNMT5%

Bulk Density NLT 0.5gm/cc



particleSizeDistribution


Impurities:

NMT0.5%

Nifedipinenitrophenypyridineanalog

Nifedipinenitrosophenypyridineanalog

NMT2.0%


CARDIOVASCULARDRUGPELLETS

METOPROLOLSUCCINATEERPELLETS

11

Physicochemical


Odorless

Appearances

Odor

Availablepercentage:47%

Availablessizes:14-20#

IHStandard

IHStandard


>85%- USPUSP

Identi�ication:A ShallbecomplyHPLC USP

USP

USP


Dissolution

Medium:Dilute

hydrochloricacid

Time:30min

RPM:1000ml

Apparatus:1

LossOnDrying NMT5.0

USPAssay 90TO110% ofLAofPropranololHydrochloride

NLT75%ofLAofamountPropranololHydrochloride

PROPRANOLOLHYDROCHLORIDEPELLETS

EnalaprilMaleatepellets

Amlodipinepellets

Isosorbidepellets

Nicardipinepellets

Telmisartanpellets

Valsartanpellets

Diltiazempellets

5%

57%,57.15%

20%,8.69%

Carvedilolpellet 54%,20%

20%

50%

54%

10%



USP


Medium:pH6.8Phosphate

Buffer; 500ml

RPM:50Apparatus:2

Time:1hrs4hrs20%-40%8hrs40%-60%20hrsNLT80%

NMT25%

Assay

60%,65%

90TO110% ofLAofMetoprolol succinate

Dissolution:

USP

USP

CompliesbyIR

CompliesbyIRUSPUSP

Identi�ication:A

Identi�ication:BIdenti�ication:CComply byHPLC

Appearances

LossonDrying

>85%-

NMT5%Bulk DensityNLT0.5gm/cc





Impurities:

Total impuritiesNMT0.75%

Anyunspeci�ieddegradation productNMT0.20.%


NEUROLOGICALPELLETS

CAFFEINEPELLETS

Physicochemical


Identi�ication


complybyHPLC

>85%- USP

BulkDensity

ResidualsolventHeavymetalsLeadArseniccadmiummercury

NLT0.5gm/ccUSP

USP

USP


Dissolution:

Medium:Water

Time:1Hr

NLT90%30min55% To85%


<2ppm

<0.6ppm<6 ppm

<6ppm

USPMicropbialLimitTest

Total aerobic microbual countTotal yeast &mould countEscherichia coli

Salmonella

USPAssay

NMT100cfu/gm

NMT10cfu/gmAbsent in1gm

Absentin10gm

90%TO110% ofLAofCaffeine

ToMeet USPstandards for class 2andclass3solvent


TOLPERISONEHCLCOATEDPELLETS

>85%-

JP


TotalAerobicmicrobialcount

Totalyeast&mouldcount

Escherichia coil

salmonella

NMT1000cfu/gm

NMT100cfu/gm

Absent in1gm

Absent in10gm

60%

MicrobialLimitTest JP

Medium:0.01MHCL

Relatedsubstance


AnyotherindividualimpurityNMT0.5%

TotalImpurityNMT1.0%

NLT85%(Q)ofLAofTolperisone

95TO105%Assay ofLAofTolperisone

Dissolved

Dissolution:

JP

JP

JP

CompliesbyHPLCJP

Identi�ication

Appearances

UntappedDensityNLT0.6TO0.7

Moisturecontent NMT3%





12

Carbamazepinepellets

Gabapentinpellets

Pregabalinepellets

Memantinepellets

Dabigatranpellets

75%

25%,50%,75%

16%

Aprepitantpellets 35%,40%

40%

15%,85%




13

TAMSULOSINHCLPELLETS

>85%

90TO110%

- USP

USP


Assay

0.133%,0.1%,0.178%,0.16%,0.2%,0.4%

ofLAofTamsulosin

Medium:pH7.2PhosphateBuffer

RPM:100Apparatus:2

Time:2hrs

RPM:100Apparatus:2Time:8hrs

38hrshrs

3hr - 47 -68%8hr- NLT80%

2hr-13-34%

USP

CompliesbyHPLC USPIdenti�ication:A

Appearances

USPLoss onDryingNMT5%






Medium:2.0sodiumchloridein5.7mlhydrochlorideacidandaddwater500ml

Dissolution:

UROLOGICALDRUGPELLETS

TOLTERODINETARTRATEERPELLETS

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

>85%- USP

BulkDensity NLT0.5gm/ccUSP

Identi�ication complybyHPLC USP

USP

USP


Dissolution:

Medium :Phosphate Buffer

pH6.8;900ml

Time: 1

2

3

7

12Hr

RPM:100Apparatus:1


USPResidualorganicsolvents

OrganicImpurities

Individual impurities NMT0.5%

Total impurities NMT0.1%

IPA-NMT5000PPMMDC-NMT500PPM

1Hr-NMT25%

2Hr-betwwen20%to50%

3Hr-betwwen40%to75%

7Hr-betwwen55%to80%

12Hr-NLT70%

AvailablePercentage:2.1%



Tamsulosin+DutasteridePellets

OxybutyninSRPellets

HydrochlorothiazidePellets 12.5%,20%

5.55%

0.4mg+0.5mg



CLARITHROMYCINTASTEMASKINGGRANULES

>85%

USP


WaterNMT5%

Whitetoslightlyoffwhitefree�lowinggranulesfreefromanyvisibleforeignparticles,whichafterreconstitutiongivesawhitetooffwhitecolored,�lavored&bitterlesssuspension

pH(afterreconstitution)Limit:8.5to11.0

Assay

27%

90TO110% ofLAof

Clarithromycin

CompliesbyHPLC

USP

USPIdenti�ication

Appearances





Description


ANTI-INFECTIVEDRUGPELLETS

14

ITRACONAZOLEPELLETS

>85%


Medium:0.25%(w/w)sodiumlaurylsulfate in0.1NHCL;900ml

NLT80%(Q) of LAof amountIntraconazole


Impurities

AnyIndividualimpurities0.2%Totalimpurities1.50%

22%,33%,35%,40%

90TO110% USPAssay ofLAofItraconazole

CompliesbyHPLC

Dissolution:

NMT5% USPUSP

USP

USP

Identi�ication:AIdenti�ication:BComply byUV

Appearances

LossondryingBulk DensityNLT5gm/cc






ANTI-INFECTIVEDRUGPELLETS

FLUCONAZOLEPELLETS

>85%

USP


Medium:Water;900mlNLT75%(Q)of LA ofamountFluconazoleisdissolvedRPM:50

Apparatus:2

Time:45min

Assay

50mg,150mg

90TO110% ofLAofFluconazole

CompliesbyHPLC

Dissolution:

NMT5%USP

USP

USP

Identi�ication

Appearances

LossonDryingBulkDensityNLTgm/cc5

Available sizes :14-20#,30-60#




15

MinocyclinePellets

NitrofurantoinPellets 50%,35%

35%,25%



MinocyclinePellets

NitrofurantoinPellets 50%,35%

35%,25%



AZITHROMYCINTASTEMASKINGGRANULES

>85%

USP


WaterNMT1.5%w/w

Whitetoslightlyoffwhitefree�lowinggranulesfreefromanyvisibleforeignparticles,whichafterreconstitutiongivesawhitetooffwhitecolored,�lavored&bitterlesssuspension

pH(afterreconstitution)Limit:8.5 to11.0

Assay

90%

90TO110% ofLAof Azithromycin

CompliesbyHPLC

USP

USPIdenti�ication

Appearances





Description



16products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. availability may be restricted to certain markets or countries.

ENDOCRINOLOGYDRUGPELLET

RESPIRATORYDRUGPELLET

METFORMINHYDROCHLORIDESRPELLETS

THEOPHYLLINEERPELLETS

>85%

90TO110% USP


Medium:pH6.8PhosphateBuffer

solution;1000ml

RPM:100

Apparatus:2

Detector:UV232nm

310

Time :1 hour

hourshours

20-40%45-65%NLT85%

Impurities

Individual impuritiesNMT 0.1%

Total impuritiesNMT 0.6%

Assay ofLAofMetformin

Hydrochloride

CompliesbyHPLC

Dissolution:

NMT5%

USP

USP

USP

USP

Identi�icationA

Appearances

LossonDrying

Bulk DensityNLT 5gm/cc





-

Dutasteridepellets0.5%



Physicochemical


Identi�ication:A

Identi�ication:B

Bulk Density NLT0.5gm/cc

LossonDrying NMT 5.0

ShallbeComplyUV

ShallbeComplyHPLC

>85%- USP

USP

USP

USP


USPAssay

Availablepercentage:60%,75%,89.25%


USPDissolution:Medium:4.5PhosphateBuffer;900ml

RPM:75Apparatus:2

Time :1hrBetween 10% to30%2hrBetween 30% to55%

Between 55% to80%4hr8hrNLT80%

90TO110%ofLAofTheophylline

DIGESTIVEENZYMESPELLETS

17

PANCREATINECPELLETS40000USP

>85%- USP

Medium:0.1Nhydrochlorideacid;900ml


Time: 2hrs

Medium:BufferpH6.8;900ml500ml


Time:45min

NLT75%ofLipaseActivity

AssayEach750mgpelletscontainpancreatin480mg

Lipase ActivityNLT40,000 USPUnitsAmylase activity NLT1,04,375 USPUnits

protease activityNLT1,00,000 USPUnitspathogentestsEscherichiacoliAbsent in 1gmSalmonella Absent in10gm

Dissolution:

USP

USP

CompliesbyUV USP

USP

Identi�ication

Appearances

Loss onDryingNMT5%


Availablesizes:14-20#,20-40#,20-60#





>85%- USP



Time: 2hrs

Medium:bufferpH6.8;900ml900ml


Time:45min


AssayEach500mgpelletscontainpancreatin 300mgNLT74700 USP .Unitsamylase activityNLT25000 USPUnitsprotease activityNLT62500 USPUnitspathogentestsescherichia colisalmonella

Absent in1gmAbsent in 10gm

Dissolution:

USP

USP

CompliesbyUV USP

USP

Identi�ication

Appearances

LossonDryingNMT5%







>85%- USP



Time: 2hrs



Time: 45min

NLT 75%ofLipaseActivity


Lipase ActivityNLT10,000 USPUnitsAmylase Activity NLT33400USPUnits

protease ActivityNLT37500 USPUnitspathogenTestsEscherichia ColiAbsent in1gmSalmonella Absent in 10gm

Dissolution:

USP

USP

CompliesbyUV USP

USP

Identi�ication

Appearances

Losson DryingNMT5%







PANCREATINECPELLETS10000EP

>85%-ph.Eur

ph.Eur

ph.Eur

ph.Eur

ph.Eur

ph.Eurph.Eur



Time: 2hrs



Time: 45min



Lipase ActivityNLT 10000 ph.EurAmylase Activity NLT8000ph.Eur

protease ActivityNLT 600ph.EurpathogenTestsEscherichiaColiAbsent in1 gmSalmonella Absebt in10gm

Dissolution:CompliesbyUVIdenti�ication

Appearances

LossonDryingNMT5%







>85%- ph.Eur

ph.Eur

ph.Eur

ph.Eur

ph.Eur

ph.Eur



Time:2hrs



Time: 45min


AssayEach500mgpelletscontainpancreatin300mg:

Lipase ActivityAmylase Activity

protease ActivityNLT25000ph.EurNLT18000ph.Eur

NLT1000ph.EurpathogenTestsEscherichiaColiSalmonella

Absent in1gmAbsebt in10gm


Appearances

LossonDryingNMT5%







>85%- ph.Eur

ph.Eur

ph.Eur

ph.Eur

ph.Eur

ph.Eur



Time: 2hrs



Time: 45min


AssayEach750mgpelletscontainpancreatin480mg:

Lipase ActivityNLT40000 Ph.EurAmylase Activity NLT25000 Ph.Eur

protease ActivityNLT1600Ph.EurpathogenTestsEscherichia ColiAbsent in1gmSalmonella Absebt in10gm


Appearances

LossonDryingNMT5%






DIGESTIVEENZYMESPELLETS


NEUTRALPELLETS

MANNITOLSPHERES

LossonDrying

Identi�ication

Speci�icopticalrotation

Acidity

LossonDrying

Chloride

Sulfate

Arsenic

Reducingsugar

Heavymetal

Assay

Physicochemical

NMT0.5%

shallcompliesinfraredabsorbance0 0Between+137 and+145

NMT 0.30ml of 0.020Nsodiumhydroxideisrequiredforneutralization

NMT0.5%

NMT0.07%

NMT0.01%

NMT1ppm.

NMT0.1%

Maximum5ppm

Between96%to101%

>85%- USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF


AvailableSizes


OdorlessOdor IHStandard

Totalaerobicmicrobialcount

Salmonella

Escherichiacoli

Staphylococcusaureus

Pseudomonasaeruginosa

Microbial Test

NMT100cfu/gm

Absent

Absent

Absent

Absent

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

75-150 150-180 180-250 250-300 425-600 600-850

MAS-75 MAS-150 MAS-180 MAS-250 MAS-425 MAS-600

19

CALCIUMCARBONATESPHERES


Salmonella

Escherichiacoli



MicrobialTest

NMT100cfu/gm

Absent

Absent

Absent

Absent

LossonDrying

Identi�ication

Acidinsolublesubstance

Limitofmagnesiumandalkali

saltsShallcomplyby

Limitof�luoride

Lead

Iron

Heavymetals

Organicvolatileimpurities

Assay

Physicochemical

>85%

NMT2%

shallrespondstothetestsforcalcium

NMT10mg

NMT5mg

NMT0.005%

NMT3ppm

Shallnotexceedthanthatofstandard

solution(0.1%)

NMT0.002%

Shallmeettherequirement

Between98.0%to100.5%

- Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

ParticleSizeDistribution75-212 106-212 150-300 300-500 500-710 710-850Availablesizes

CCS-75 CCS-106 CCS-150 CCS-300 CCS-710CCS-500


Odorless

Appearances

Odor

IHStandard

IHStandard


NEUTRALPELLETS

TARTARICACIDSPHERES

MicrobialTest

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Appearances

Odor

LossonDryingIdenti�icationAsolutionstronglyacidReactionoftartaratesAppearanceofsolution

CalciumChlorideSpeci�icopticalrotationLimitofoxalateSulphateHeavyMetalsResidueonignitionAssay

Physicochemical


Odorless

Ph.Eur./USP/NFPh.Eur./USP/NF

Ph.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NF

Ph.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NFPh.Eur./USP/NF


IHStandard

IHStandard

180-250 250-300 300-425 425-600 600-850500-710


Salmonella

Escherichiacoli



NMT100cfu/gm

Absent

Absent

Absent

Absent

NMT0.5%

StronglyacidicIRspectrumequivalentreferencestandardClear andnotmore intensely colored thanreference200ppm100ppm

0 0+12.0 to+12.8Complies150ppm

10ppm

0.05%99.7to100.5%

>85%-

<-<-

<-<-<-

TAS-180 TAS-250 TAS-300 TAS-425 TAS-500 TAS-600

SUGARSPHERES

>85%-

betwwen+41and+61

residue

sulfateash

onignitionNMT0.25%

0.2%

sugar

Speci�icopticalrotationin5.7mlofhydrochlorideacid

contentNLT62.5%andNMT91.5% of sucrose

Heavy metalsNMT 5.0 ppm

Microbialtest

Total aerobic microbial countNMT100cfu/gmsalmonellaAbsentsalmonellaAbsentescherichia coliAbsentstaphylococcus aureusAbsentpseudomonas aeruginosaAbsent

0%Friability

Appearances

LossonDryingBulkDensity

NMT4%NLT 0.5gm/cc



IHstandardIHstandard

Hard,brittle,free�lowing,sphericalmasses

Ph.Eur./USP/NF

Ph.Eur./USP/NFPh.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

SSS-100 SSS-200 SSS-350 SSS-500 SSS-700 SSS-1000

100-200 200-355 350-500 500-710 710-1000 1000-1400Availablesizes


OdorlessOdor

NEUTRALPELLETS

LACTOSESPHERES

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

LMS-180 LMS-250 LMS-300 LMS-425 LMS-600 LMS-850

LossondryingIdenti�ication:A

Identi�ication:BResidueonignition

Speci�icopticalrotation

NMT2%CompliesIR

CompliesTLCNMT0.1%

HeavyMetals NMT5g/g0 0+54.4 to+55.9

Acidity&Alkalinity NMT 0.4 ml of0.1N sodiumhydroxide required toproducedaredcolor

Lossondrying NMT0.5%

>85%- USP/NFUSP/NF

USP/NFUSP/NF

USP/NF

USP/NFUSP/NF

USP/NF

USP/NF


Protein &light absorbingNMT0.25 inthe range of210-220 &NMT0.07intherange of270-300mm

Impurities

Sulfatedash

Microbialtest

Salmonella Absent

Escherichia coli Absent

staphylococcus aureus Absent

Pseudomonas aeruginosa Absent

AbsentTotalaerobicmicrobialcount

Water 4.5%to5.5%

NMT0.1%

180-250 250-300 300-425 425-600 600-850 850-1000Availablesizes

CITRICACIDSPHERES

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

LossonDrying

Identi�ication

Residueonignition

HeavyMetals

Sulfate

Limitofoxalic

Water

Assay

NMT2%

ShallComplyUSP

NMT0.1%

NMT10ppm

ShallcomplyUSP

ShallcomplyUSP

NMT1%

99.5%to100.5%oflabeledamount

>85%- USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF


Totalaerobicmicrobial

count

Salmonella

Escherichiacoli



MicrobialTest

NMT100cfu/gm

Absent

Absent

Absent

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

300-425 425-600 600-850 850-1000 1000-1180 1400-1700

CAS-300 CAS-425 CAS-600 CAS-850 CAS-1000 CAS-1400

Availablesizes


MCCSPHERES

NEUTRALPELLETS

22

SILICASPHERES


Salmonella

Escherichiacoli



MicrobialTest

NMT100cfu/gm

Absent

Absent

Absent

Absent

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Lossondrying

Identi�ication

pH

Lossondrying

LossonIgnition

Organicvolatileimpurities

Heavymetals

Assay

Physicochemical

>85%

NMT0.5%

shallproduceddeepyellowcolor

4to8

NMT5.0%

NMT805%

meetstherequirement

NMT0.0037%

90%to110%oflabeledamount

- USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

USP/NF

ParticlesizeDistribution75-212 106-212 150-300 300-500 710-850

SDS-75 SDS-106 SDS-150 SDS-300 SDS-710

Availablesizes


Odorless

IHStandard

IHStandard

Appearances

Odor


Salmonella

Escherichiacoli



MicrobialTest

NMT100cfu/gm

Absent

Absent

Absent

Absent

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Lossondrying

Bulkdensity

Friability

Identi�ication

ZincChlorideTest

Degreeofpolymerizations

pHValue

Conductivity/cm/S

Ethersolublesubstances

Watersolublesubstances

Heavymetals

Sulfatedash

Physicochemical

>85%

NMT7.0%

0.5gm/cc(forinformationonly)

0%

Passes

NMT350

5.0-7.0

NMT75

NMT0.05%

NMT0.24%

NMT0.001%

NMT0.05%

- Ph.Eur./USP/NF

Ph.Eur./USP/NF

IHStandard

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

ParticleSizeDistribution75-212 106-212 150-300 300-500 710-810500-710

MCS-75 MCS-106 MCS-150 MCS-300 MCS-500 MCS-710

Availablesizes


Odorless

IHStandard

IHStandard

Appearances

Odor


23

VITAMINSANDMINERALS

ASCORBICACIDIRPELLETS

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication:A

Identi�ication:B

Identi�ication:C

shallcomply

shallcomply

shallcomply


>85%- USP

USP

USP

USP

USP


AvailablePercentage:90%


Dissolution

Medium:Water;900ml

Time:45min

RPM:50

Apparatus:2

LossOnDrying NMT5.0

USPAssay 90TO110% ofLAofAscrobicAcid

NLT75%(Q)ofLAofamountAscrobicAciddissolved45MIN

FERROUSSULFATEIRPELLETS

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication shallbecomply


>85%- USP

USP

USP

USP

USP


Dissolution:

Medium:0.1

hydrochloricacid;900ml

Time:45min

RPM:50

Apparatus:2

LossOnDrying NMT5.0

USPAssay 90TO110% ofLAofFerrousSulphate

NLT75%(Q)ofLAofamountFerroussulfate


Availablepercentage:75%,90%


24

FOLICACIDPELLETS

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication


LossonDrying NMT5.0

complybyUV

>85%- USP

USP

USP

USP


Dissolution:Medium:Water500ml

RPM:50Apparatus:2

NLT75%ofLAofFolicAcid

Assay90% to115.0%of laamountofFolicAcid



Time:45min

DRIEDFERROUSSULPHATE&FOLICACIDPELLETS

VITAMINSANDMINERALS

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication:Folic

Identi�ication:Iron

Identi�ication:Sulphate

BulkDensityNLT0.8to1.00gm/cc

LossonDryingNMT3.5

ShallbeComply

ShallbeComply

ShallbeComply

>85%-

USP

USP

USP

USP


USPAssayDried ferrous sulphate (150mg) NLT90.0% andNMT120.0%Folicacid (0.5mg) NLT90.0% oflabel claimMicrobiallimitTestTotal aerobic microbial test NMT1000 cfu/gmTotalcombinedmolds&yeast NMT100cfu/gmPathogens Shallbeabsent



USPDissolution:Medium:PhosphateBufferpH7.4

RPM:100Apparatus:1

Time :1hrBetween 15.0% to45.0%2hrBetween35.0%to80.0%4hrNLT70%

Carbonyl+IronFolicAcid+

VitaminEPellets

MenthaPiperitaECoilPellets

ALAPelletsFolicAcid

Ferrous+Folic

PolysaccharideIronPellets

ZincSulphatePellets+VitaminCPellets

+50mg

40%

25%

75%2%,5%

150mgSR+0.5mg

23.7%

61.8mg0.5mg+




25

VITAMINSANDMINERALS

FERROUSGLYCINESULPHATEECPELLETS

Physicochemical


Odorless

Appearances

Odor

IHStandard

IHStandard

Identi�ication complybyUV

>85%- USP


USP

USP

USP

USP

USP




Dissolution:

Dissolution:

Medium:0.1MHCL900ml

Time: 2Hr

RPM:100

Medium:bufferpH6.8

900ml

Time:45min

RPM:100Apparatus:paddle37c+0.5c_


NMT15%inAcid

NLT75%Buffer

MicropbialLimitTest

Total aerobic microbual countTotal yeast &mould countEscherichia coli

Salmonella

Assay90%to110%ofLaamount.

NMT100cfu/gmNMT10cfu/gmAbsent in1gm

Absentin10gm

CARBONYLIRONSRPELLETS

Physicochemical


Odorless

Appearances

OdorIHStandard

IHStandard

Identi�icationCarbonylIron

FolicAcid

complybyUV

complybyHPLC

>85%- USP


USP

USP

USP

USP


Dissolution

Medium:0.1MHCL/900ml

RPM:50

Apparatus:Basket

Time:1Hr

2Hr

4Hr


Between15%to45%

Between35%to80%

NLT70%

MicropbialLimitTest

Total aerobicmicrobualcountTotal yeast &mould countEscherichiacoli

Salmonella

Assay90% to110% ofLaamount.

NMT100cfu/gmNMT10cfu/gmAbsent in1gm

Absentin10gm




Products protected by valid Patents are not offered for sale in Countries where the sale of such Products constitutes patent infringement. Availability may be restricted to

certain markets or Countries. 26

MOUTHDISSOLVINGFILMS

SILDENAFILCITRATESTRIPS

Length

Width

Thickness

Folding enduranceNLT 3Folds

SurfacepH

Uniformityofwt

Identi�ication

Uniformityofcontent

Disintegrationtime

Dissolution

Assay90%TO 110%OF LA

Physiochemical

110+15

25to35mm

20to30mm

135 to145

4TO8

tobecomplies

ComplybyHPLC

between85%to115%

Notmorethan5min

Notlessthan75%

- Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

Ph.Eur./USP/NF

AverageWeight

DoseAvailable:25mg,50mg,100mg

Bluecoloredstrip IHstandardsAppearance

TADALAFILSTRIPS

Length

Width

Thickness

Folding enduranceNLT 3 Folds

SurfacepH

Uniformityofwt

Identi�ication

Uniformityofcontent

Disintegrationtime

Dissolution

Assay90%TO 110%OF LA

Physicochemical

25to35mm

20to30mm

85to95micrones

4TO8

Tobecomplies

ComplybyHPLC

between85%to115%

Notmorethan5min

Notlessthan75%

DoseAvailable:10mg,20mg

80mg+15%-AverageWeight USP

USP

USP

USP

USP

USP

USP

USP

USP

USP

USP

USP

Yellowcoloredstrip IHstandards

IHstandards

Appearance

Odor Odorless

27

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A4 PHARMA CATALOG - Copy · 2020. 11. 18. · Impurity : Individual impurity Any other unspeciied Impurity Total Impurity Impurity Assay NMT 0.5% FOR Fenoibrate related compound B