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Sr No.IMPURITY NAMEIUPAC NAMECAS NO.Molecular FormulaMolecular Weight
1Aciclovir Impurities
aAciclovir RS2-Amino-9-((2-hydroxyethoxy)methyl)-1H-purin-6(9H)-one 59277-89-3 C8H11N5O3225.2
bAciclovir EP Impurity-B2-Amino-1H-purin-6(7H)-one73-40-5C5H5N5O151.1
cAciclovir EP Impurity-G2-((2-Acetamido-6-oxo-1H-purin-9(6H)-yl)methoxy)ethyl acetate, Synonyms:Acyclovir Related Compound G;Aciclovir EP Impurity G;Diacetyl Acyclovir75128-73-3C12H15N5O5309.2
dAciclovir EP Impurity-LN-(9-Acetyl-6-oxo-6,9-dihydro-1H-purin-2-yl)acetamide3056-33-5C9H9N5O3235.2
2Acelofenac Impurities
aAcelofenac RS2-(2-(2-((2,6-Dichlorophenyl)amino)phenyl)acetoxy)acetic acid Synonyms:Preservex; Airtal89796-99-6C16H13Cl2NO4354.2
bAcelofenac EP Impurity A[2[2,6-dichlorophenyl)amino]phenyl]acetic acid15307-86-5C14H11Cl2NO2296.147
cAcelofenac EP Impurity BMethyl[2[2,6-dichlorophenyl)amino]phenyl]acetate15307-78-5C15H13Cl2NO2310.174
dAcelofenac EP Impurity CEthyl[2[2,6-dichlorophenyl)amino]phenyl]acetate15307-77-4C16H15Cl2NO2324.2
eAcelofenac EP Impurity DMethyl[[[2[2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate139272-66-5C17H15Cl2NO4368.2
fAcelofenac EP Impurity EEthyl[[[2[2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate139272-67-6C18H17Cl2NO4382.2
gAcelofenac EP Impurity FBenzyl[[[2[2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate100499-89-6 C23H19Cl2NO4444.3
hAcelofenac EP Impurity G{[({[2-(2,6-dichloroanilino)phenyl]acetyl}oxy)acetyl]oxy}acetic acid 1215709-75-3C18H15Cl2NO6412.2
iAcelofenac EP Impurity H[({[({[2-(2,6-dichloroanilino)phenyl]acetyl}oxy)acetyl]oxy}acetyl)oxy]acetic acid1216495-92-9C20H17Cl2NO8470.2
jAcelofenac EP Impurity I1-(2,6-Dichlorophenyl)-2-indolinone15362-40-0C14H9Cl2NO278.1
kAcelofenac tert butyl ester 2-(tert-Butoxy)-2-oxoethyl 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate139272-68-7C20H21Cl2NO4 410.3
l4-Hydroxy Acelofenac 2-(2-(2-((2,6-Dichloro-4-hydroxyphenyl)amino)phenyl)acetoxy)acetic acid or ({[2-(2,6-dichloro-4-hydroxyanilino)phenyl]acetyl}oxy)acetic acid229308-90-1C16H13Cl2NO5370.2
3Acesulfame Impurities
aAcesulfame Potassium RSN/A55589-62-3C4H5NO4S : K163.1 : 39.1
bAcesulfame Potassium EP Impurity AN/A5977-14-0C4H7NO2101.1
cAcesulfame Potassium EP Impurity BN/A72827-08-8C4H4ClNO4S197.6
4Acetazolamide Impurities
aAcetazolamide EP Impurity AN-(5-Chloro-1,3,4-thiadiazol-2-yl)acetamide60320-32-3 C4H4ClN3OS177.6
bAcetazolamide EP Impurity CN-(5-Mercapto-1,3,4-thiadiazol-2-yl)acetamide32873-56-6C4H5N3OS2175.2
cAcetazolamide EP Impurity D5-Amino-1,3,4-thiadiazole-2-sulfonamide14949-00-9C2H4N4O2S2180.2
dAcetazolamide EP Impurity E5-Acetamido-1,3,4-thiadiazole-2-sulfonic acid827026-60-8C4H5N3O4S2223.2
eAcetazolamide EP Impurity G5-Amino-1,3,4-thiadiazole-2-thiol2349-67-9C2H3N3S2133.1
5Acetylcysteine Impurities
aAcetylcysteine(R)-2-Acetamido-3-mercaptopropanoic acid616-91-1C5H9NO3S163.2
bAcetylcysteine EP Impurity A (L-Cystine)(2R,2'R)-3,3'-Disulfanediylbis(2-aminopropanoic acid)56-89-3C6H12N2O4S2240.3
cAcetylcysteine EP Impurity B Hydrochloride(R)-2-Amino-3-mercaptopropanoic acid hydrochloride52-89-1 C3H7NO2S : HCl121.2 : 36.5
dAcetylcysteine EP Impurity CN,N'-Diacetyl-L-Cystine5545-17-5C10H16N2O6S2324.4
eAcetylcysteine EP Impurity D(R)-2-Acetamido-3-(acetylthio)propanoic acid18725-37-6C7H11NO4S205.2
fN-Acetyl-L-Cysteine(R)-2-Acetamido-3-(((R)-2-amino-2-carboxyethyl)disulfanyl)propanoic acid25779-79-7C8H14N2O5S2282.3
6Alfuzosin Impurities
aAlfuzosin EP Impurity B2-Chloro-4-amino-6,7-dimethoxyquinazoline23680-84-4C10H10CIN3O2239.7
7Albendazole Impurities
aAlbendazole EP Impurity A5-(propylsulfanyl)-1H-1,3-benzimidazol-2-amine80983-36-4 C10H13N3S207.3
bAlbendazole EP Impurity BMethyl (6-(propylsulfinyl)-1H-benzo[d]imidazol-2-yl)carbamate, Synonyms:Ricobendazole54029-12-8C12H15N3O3S281.3
cAlbendazole EP Impurity IMethyl (5-propoxy-1H-benzo[d]imidazol-2-yl)carbamate Synonyms:Anthelcide-EQ 20559-55-1 C12H15N3O3249.3
8Allopurinol Impurities
aAllopurinol RS1H-Pyrazolo[3,4-d]pyrimidin-4(5H)-one,315-30-0C5H4N4O136.1
bAllopurinol EP Impurity A (Sulfate)3-Amino-1H-pyrazole-4-carboxamide sulfate(2:1) 27511-79-12(C4H6N4O) : H2O4S2(126.1) : 98.1
cAllopurinol EP Impurity DEthyl 3-amino-1H-pyrazole-4-carboxylate6994-25-8C6H9N3O2155.2
dAllopurinol EP Impurity F (Hydrazine)Hydrazine302-01-2 H4N232.1
eAllopurinol Nitrile Impurity3-Amino-1H-pyrazole-4-carbonitrile16617-46-2 C4H4N4108.1
9Alogliptin Impurities
aAlogliptin Benzoate RS(R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile benzoate850649-62-6C18H21N5O2 : C7H6O2339.4 : 122.1
10Anagrelide Impurities
aAnagrelide RS6,7-Dichloro-5,10-dihydroimidazo[2,1-b]quinazolin-2(3H)-one hydrochloride58579-51-4C10H7Cl2N3O•HCl292.55
bAnagrelide USP Related compound AEthyl 2-((6-amino-2,3-dichlorobenzyl)amino)acetate70406-92-7 C11H14Cl2N2O2277.2
11Apixaban Impurities
aApixaban RS1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide503612-47-3C25H25N5O4459.5
bApixaban Impurity A (Apixaban Acid impurity)1-(4-Methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid503614-92-4C25H24N4O5460.5
cApixaban Impurity 9 (Ethyl ester)Ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate503614-91-3C27H28N4O5488.6
dApixaban USP Related Compound E (Methyl ester of Apixaban)Methyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate1074365-84-6C26H26N4O5474.5
12Amitriptyline Impurities
aAmitriptyline EP Impurity A10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-one,1210-35-1 C15H12O208.3
bAmitriptyline EP Impurity B3-(5H-Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine hydrochloride6202-23-9 C20H21N : HCl 275.4 : 36.5
cAmitriptyline EP Impurity G5-Hydroxy-10,11-dihydro-5H-dibenzo[a,d][7]annulene Synonyms:Dibenzo(b,f)cycloheptan-1-ol;1,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ol1210-34-0C15H14O210.3
13Amlodipine Besylate Impurities
aImpurity A (USP Related compound-D)3-Ethyl 5-methyl 4-(2-chlorophenyl)-2-((2-(1,3-dioxoisoindolin-2-yl)ethoxy)methyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate,88150-62-3 C28H27ClN2O7539
bImpurity B (USP Related compound-B)3-Ethyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-((2-(2-(methylcarbamoyl)benzamido)ethoxy)methyl)-1,4-dihydropyridine-3,5-dicarboxylate721958-72-1 C29H32ClN3O7570.1
cImpurity D (Amlodipine Related Compound A )3-Ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate113994-41-5 C20H23ClN2O5406.9
dImpurity GDimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate43067-01-2C17H18ClNO4335.8
eImpurity H2-((2-((4-(2-Chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4-dihydropyridin-2-yl)methoxy)ethyl)carbamoyl)benzoic acid318465-73-5C28H29ClN2O8557
14Amiodarone Impurities
aAmiodarone Hydrochloride(2-Butylbenzofuran-3-yl)(4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl)methanone hydrochloride19774-82-4C25H29I2NO3 : HCl645.3 : 36.5
bAmiodarone EP Impurity D(2-Butylbenzofuran-3-yl)(4-hydroxy-3,5-diiodophenyl)methanone,1951-26-4C19H16I2O3546.1
15Aspartame Impurities
aAspartame RS(S)-3-Amino-4-(((S)-1-methoxy-1-oxo-3-phenylpropan-2-yl)amino)-4-oxobutanoic acid22839-47-0C14H18N2O5294.3
bAspartame EP Impurity B(S)-3-Amino-4-(((S)-1-carboxy-2-phenylethyl)amino)-4-oxobutanoic acid,13433-09-5 C13H16N2O5280.3
16Atenolol Impurities
aAtenolol EP Impurity A4-Hydroxyphenylacetamide17194-82-0C8H9NO2151.2
17Aripiprazole Impurities
aAripiprazole EP Impurity A7-Hydroxy-3,4-dihydroquinolin-2(1H)-one Synonyms:3,4-Dihydro-7-hydroxy-2(1H)-quinolinone22246-18-0C9H9NO2163.2
18Atorvastatin Impurities
aAtorvastatin Calcium TrihydrateCalcium (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate trihydrate44423-98-9 C33H34FN2O5 : 1/2(Ca) : 3/2H2O557.6 : 1/2(40.1) : 3/2(18.0)
bAtorvastatin Diketo Amide Impurity2-(2-(4-Fluorophenyl)-2-oxo-1-phenylethyl)-4-methyl-3-oxo-N-phenylpentanamide125971-96-2C26H24FNO3417.5
19Benserazide Impurities
aBenserazide Hydrochloride2-Amino-3-hydroxy-N'-(2,3,4-trihydroxybenzyl)propanehydrazide hydrochloride,14919-77-8C10H15N3O5 : HCl257.2 : 36.5
bBenserazide EP Impurity ADL-Serine Hydrazide Hydrochloride55819-71-1C3H9N3O2 : HCl119.1 : 36.5
20Bisoprolol impurities
aBisoprolol EP Impurity S4-Hydroxybenzaldehyde123-08-0C7H6O2122.1
21Bilastine Impurities
aBilastine2-(4-(2-(4-(1-(2-Ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid, 202189-78-4C28H37N3O3463.6
22Brimonidine impurities
aBrimonidine RSN/A59803-98-5C11H10BrN6293.1
bBrimonidine EP Impurity AN-(4,5-Dihydro-1H-imidazol-2-yl)quinoxalin-6-amine91147-43-2C11H11N5213.2
cBrimonidine EP Impurity B6-Amino-5-bromoquinoxaline50358-63-9C8H6BrN3224.1
dBrimonidine EP Impurity CQuinoxalin-6-amine6298-37-9C8H7N3145.2
eBrimonidine EP Impurity D1-(5-Bromoquinoxalin-6-yl)thiourea842138-74-3C9H7BrN4S283.2
23Bisacodyl Impurities
aBisacodyl RS(Pyridin-2-ylmethylene)bis(4,1-phenylene) diacetate603-50-9 C22H19NO4361.4
bBisacodyl EP Impurity A4,4'-(Pyridin-2-ylmethylene)diphenol603-41-8C18H15NO2277.3
cBisacodyl EP Impurity B2-((4-Hydroxyphenyl)(pyridin-2-yl)methyl)phenol16985-05-0C18H15NO2277.3
24Brexpiprazole Impurities
aBrexpiprazole baseN/A913611-97-9N/AN/A
bBrexpiprazole Impurity-11-(Benzo[b]thiophen-4-yl)piperazine hydrochloride913614-18-3C12H14N2S : HCl 218.3 : 36.5
cBrexpiprazole Impurity-24-Bromobenzo[b]thiophene5118-13-8C8H5BrS213.1
dBrexpiprazole Impurity-37-(4-Chlorobutoxy)quinolin-2(1H)-one,913613-82-8 C13H14ClNO2251.7
eBrexpiprazole N-Oxide7-[4-(4-Benzo[b]thien-4-yl-1-oxido-1-piperazinyl)butoxy]-2(1H)-quinolinone1191900-58-9C25H27N3O3S449.6
fBrxpiprazole Bromo4-Bromo-2,3-dihydrobenzo[b]thiophene203395-59-9C13H14BrNO2296.2
jBrexpiprazole Alcohol7-(4-Hydroxybutoxy)quinolin-2(1H)-one1886188-97-1C13H15NO3233.3
hBrexpiprazole Dimer7,7`-(Butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one)2116542-19-7C22H20N2O4376.4
i7-Hydroxyquinolinone7-Hydroxy-2(1H)-quinolinone; 7-Hydroxy-1H-quinolin-2-one70500-72-0C9H7NO2161.16
25Butenafine Impurities
aButenafine Hydrochloride RSN-(4-(tert-Butyl)benzyl)-N-methyl-1-(naphthalen-1-yl)methanamine hydrochloride101827-46-7C23H27N : HCl 317.5 : 36.5
bButenafine Impurity-11-(tert-Butyl)-4-(chloromethyl)benzene19692-45-6C11H15Cl182.7
cButenafine Impurity-2N-Methylnaphthalen-1-amine2216-68-4C11H11N157.2
26Carbamazepine Impurities
aCarbamazepine RS5H-Dibenzo[b,f]azepine-5-carboxamide298-46-4C15H12N2O236.3
cCarbamazepine EP Impurity A10,11-Dihydro-5H-dibenzo[b,f]azepine-5-carboxamide3564-73-6C15H14N2O238.3
dCarbamazepine EP Impurity B9-Methylacridine611-64-3C14H11N193.2
eCarbamazepine EP Impurity D5H-Dibenzo[b,f]azepine256-96-2C14H11N193.2
fCarbamazepine EP Impurity E10,11-Dihydro-5H-dibenzo[b,f]azepine494-19-9 C14H13N195.3
jCarbamazepine EP Impurity G10-Bromo-5H-dibenzo[b,f]azepine-5-carboxamide59690-97-0C15H11BrN2O315.2
27Carvedilol Phosphate
aCarvedilol USP Related Compound D4-Glycidyloxycarbazole51997-51-4C15H13NO2239.3
bCarvedilol USP Related Compound E2-(2-Methoxyphenoxy)ethylamine1836-62-0C9H13NO2167.2
cCarvedilol 4-Hydroxycarbazole Impurity9H-Carbazol-4-ol52602-39-8C12H9NO183.2
28Celecoxib
aCelecoxib RS4-(5-(p-Tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide169590-42-5C17H14F3N3O2S381.4
bCelecoxib USP Related Compound D4-(2-(1-(p-Tolyl)ethylidene)hydrazinyl)benzenesulfonamide1061214-06-9 C15H17N3O2S303.4
cCelecoxib EP Impurity G4,4,4-Trifluoro-1-(p-tolyl)butane-1,3-dione720-94-5C11H9F3O2230.2
29Captopril Impurities
aCaptopril RS(S)-1-((S)-3-mercapto-2-methylpropanoyl)pyrrolidine-2-carboxylic acid2571-86-2 C9H15NO3S217.3
bCaptopril EP Impurity D3-Bromo-2-methylpropanoic acid56970-78-6C4H7BrO2167
30Cetirizine Impurities
aCetirizine Dihydrochloride RS2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride83881-52-1C21H25ClN2O3 : 2(HCl)388.9 : 2(36.5)
bCetirizine EP Impurity A 1-((4-Chlorophenyl)(phenyl)methyl)piperazine303-26-4C17H19ClN2286.8
cCetirizine EP Impurity D1,4-Bis((4-chlorophenyl)(phenyl)methyl)piperazine dihydrochloride856841-95-7C30H28Cl2N2 : 2(HCl)487.7: 2(36.5)
dCetirizine 4-CBH impurity (USP)4-Chlorobenzhydrol119-56-2C13H11ClO218.7
eCetirizine 4-Chlorobenzophenone Impurity (USP)4-Chlorobenzophenone134-85-0C13H9ClO216.7
fNitrosoamine impurity of Cetirizine EP Impurity A 
31Chlorphenamine Impurities
aChlorphenamine Maleate3-(4-Chlorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amine maleate113-92-8C16H19ClN2 : C4H4O4274.8 : 116.1
bChlorphenamine EP Impurity BDi(pyridin-2-yl)amine202-34-2C10H9N3171.2
32Ciclopirox Impurities
aCiclopirox6-Cyclohexyl-1-hydroxy-4-methylpyridin-2(1H)-one 2-aminoethanol salt41621-49-2C12H17NO2 : C2H7NO207.3 : 61.1
bCiclopirox EP Impurity B6-Cyclohexyl-4-methyl-2H-pyran-2-one14818-35-0C12H16O2192.3
33Cinacalcet Impurities
aCinacalcet HCl RS(R)-N-(1-(Naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine hydrochloride364782-34-3C22H22F3N : HCl357.4 : 36.5
bCinacalcet USP Related Compound Dent-Cinacalcet Hydrochloride1217809-88-5 C22H22F3N : HCl357.4 : 36.5
cCinacalcet Impurity A(R)-1-(Naphthalen-1-yl)ethanamine hydrochloride82572-04-1C12H13N : HCl171.2 : 36.5
dCinacalcet Impurity B(R)-N-Benzyl-1-(naphthalen-1-yl)ethanamine hydrochloride163831-65-0 C19H19N : HCl261.4 : 36.5
eNitrosamine imp of Cinacalcet
34Clenbuterol Hydrochloride
aClenbuterol EP Impurity A4-Amino-3,5-dichlorobenzaldehyde62909-66-4C7H5Cl2NO190
bClenbuterol EP Impurity B1-(4-Amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone37148-49-5C12H16Cl2 N2O275.17
cClenbuterol EP Impurity C4'-Amino-3',5'-dichloroacetophenone37148-48-4C8H7Cl2NO204.1
dClenbuterol EP Impurity D1-(4-Aminophenyl)ethanone99-92-3C8H9NO135.16
eClenbuterol EP Impurity E1-(4-Amino-3,5-dichlorophenyl)-2-bromoethanone 37148-47-3C8H6BrCl2 NO282.94
fClenbuterol EP Impurity F(1RS)-1-(4-Amino-3-bromo-5-chlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanol 37153-52-9 C12H18BrCl N2O321.64
gMono chloro impurity1-(4-amino-3-chlorophenyl)ethan-1-one6953-83-9C8H8Cl NO169.61
35Ciprofloxacin Impurities
aCiprofloxacin EP Impurity A7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid86393-33-1C13H9ClFNO3281.7
bN-Nitroso CiprofloxacinN/A864443-44-7 C17H17FN4O4360.3
cN-Nitroso Ciprofloxacin EP Impurity CN/AN/AC15H15FN4O4334.3
36Clotrimazole Impurities
aClotrimazole EP Impurity C(Chloro(2-chlorophenyl)methylene)dibenzene42074-68-0C19H14Cl2313.2
bClotrimazole EP Impurity D1H-Imidazole 288-32-4C3H4N268
cClotrimazole EP Impurity E(2-Chlorophenyl)(phenyl)methanone1191489C13H9ClO216.6
dClotrimazole EP Impurity F1-Trityl-1H-imidazole15469-97-3C22H18N2310.4
eClotrimazole DeschloroanalogeChloromethanetriyl)tribenzene76-83-5N/AN/A
37Cyclizine Impurities
aCyclizine
bCyclizine Hydrochloride EP Impurity BDiphenylmethanol,91-01-0 C13H12O184.2
cCyclizine Hydrochloride EP Impurity A1-Methylpiperazine 109-01-3C5H12N2100.2
38Dabigatran Impurities
aDabigatran Etexilate RSHexyl 2-(4-(((5-((3-ethoxy-3-oxopropyl)(pyridin-2-yl)carbamoyl)-1-methyl-1H-benzo[d]imidazol-2-yl)methyl)amino)benzylidene)hydrazinecarboxylate211915-06-9C34H41N7O5627.7
39Deferasirox Impurities
aDeferasirox RS4-(3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)benzoic acid201530-41-8C21H15N3O4373.4
bDeferasirox Benzamide Impurity2-Hydroxybenzamide 65-45-2C7H7NO2137.1
cDeferasirox EP Impurity A2-Hydroxy-N-(2-hydroxybenzoyl)benzamide1972-71-0C14H11NO4257.2
dDeferasirox EP Impurity F4-Hydrazinylbenzoic acid619-67-0C7H8N2O2152.2
40Dicycloverine impurities
aDicycloverine EP Impurity A[1,1'-Bi(cyclohexane)]-1-carboxylic acid0263-54-9C13H22O2210.3
bDicycloverine Impurity 1Bicyclohexyl92-51-3 C12H22166.3
41Diclofenac Impurities
aDiclofenac Sodium RS
bDiclofenac EP Impurity A1-(2,6-Dichlorophenyl)-2-indolinone15362-40-0 C14H9Cl2NO278.1
cDiclofenac EP Impurity B2-((2,6-Dichlorophenyl)amino)benzaldehyde22121-58-0 C13H9Cl2NO266.1
dDiclofenac EP Impurity C(2-((2,6-Dichlorophenyl)amino)phenyl)methanol27204-57-5 C13H11Cl2NO268.1
eDiclofenac EP Impurity D (Diclofenac bromo analogue 2-(2-((2-Bromo-6-chlorophenyl)amino)phenyl)acetic acid127792-23-8 C14H11BrClNO2340.6
fDiclofenac EP Impurity EIndolin-2-one59-48-3C8H7NO133.2
gDiclofenac EP Impurity FN-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)acetamide560075-65-2 C14H10Cl3NO314.6
hN-Nitroso Diclofenac2-(2-((2,6-Dichlorophenyl)(nitroso)amino)phenyl)acetic acid66505-80-4 C14H10Cl2N2O3325.1
iDiclofenac benzaldehyde analogue 2-[(2,6-Dichlorophenyl)amino]benzaldehyde22121-58-0C13H9Cl2NO266.12
jDiclofenac alcohol analogue{2-[(2,6-dichlorophenyl)amino]phenyl}methanol27204-57-5C13H11Cl2NO268.14
kDiclofenac Keto analog2-[(2,6-Dichlorophenyl)amino]phenyl-2-oxoacetic acid66156-75-0C14H8Cl2NNaO3332.11
l Diclofenac BP Impurity-A1-(2,6-Dichlorophenyl)-2-indolinone15362-40- 0C14H9Cl2NO278.13
42Dicloxacllin Impurities
aDicloxacillin EP Impurity A(2R,4S)-2-((R)-Carboxy(3-(2,6-dichlorophenyl)-5-methylisoxazole-4-carboxamido)methyl)-5,5-dimethylthiazolidine-4-carboxylic acid 42947-69-3C19H19Cl2N3O6S488.3
bDicloxacillin EP Impurity C(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid551-16-6 C8H12N2O3S216.3
cDicloxacillin EP Impurity D3-(2,6-Dichlorophenyl)-5-methylisoxazole-4-carboxylic acid3919-76-4C11H7Cl2NO3272.1
43Donepezil Impurities
aDonepezil HCL RS2-((1-Benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one hydrochloride120011-70-3 C24H29NO3 : HCl379.5 : 36.5
bDonepezil EP Impurity F(E)-2-((1-Benzylpiperidin-4-yl)methylene)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one145546-80-1C24H27NO3377.5
cHydroxy Donepezil2-((1-Benzylpiperidin-4-yl)(hydroxy)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one197010-20-1C24H29NO4395.5
dDonepezil Benzyl Bromide1,1-Dibenzyl-4-((5,6-dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl)piperidin-1-ium bromide844694-85-5C31H36NO3 : Br470.6 : 79.9
eDehydrodeoxy Donepezil1-Benzyl-4-((5,6-dimethoxy-1H-inden-2-yl)methyl)piperidine120013-45-8C24H29NO2363.5
fDeoxy Donepezil1-Benzyl-4-((5,6-dimethoxy-2,3-dihydro-1H-inden-2-yl)methyl)piperidine hydrochloride1034439-57-0 C24H31NO2 : HCl365.5 : 36.5
gDonepezil EP Impurity A5,6-Dimethoxy-2-(piperidin-4-ylmethyl)-2,3-dihydro-1H-inden-1-one120014-30-4C17H23NO3289.4
hDonepezil N-Oxide1-Benzyl-4-((5,6-dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl)piperidine 1-oxide120013-84-5C24H29NO4395.5
iDonepezil EP Impurity D5,6-Dimethoxy-2-(pyridin-4-ylmethyl)-2,3-dihydro-1H-inden-1-one4803-57-0 C17H17NO3283.3
jDonepezil Aldehyde Impurity1-Benzylpiperidine-4-carbaldehyde22065-85-6 C13H17NO203.3
kDonepezil EP Impurity B5,6-Dimethoxy-2,3-dihydro-1H-inden-1-one2107-69-9 C11H12O3192.2
lDonepezil Impurity4-Pyridinecarboxaldehyde872-85-5C6H5NO107.11
mN-Nitroso Donepezil EP Impurity AN/AN/AC17H22N2O4318.4
44Doxepin
aDoxepin EP impurity ADibenzo[b,e]oxepin-11(6H)-one4504-87-4C14H10O2210.23
bDoxepin EP impurity C(E)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride 4504-96-5 C18H20ClNO301.81
45Duloxetine Impurities
aDuloxetine HydrochlorideN/A136434-34-9C18H19NOS : HCl297.4 : 36.5
bDuloxetine EP Impurity B(S)-(-)-3-(N-Methylamino)-1-(2-thienyl)-1-propanol116539-55-0 C8H13NOS171.3
cDuloxetine EP Impurity D1-Naphthol90-15-3C10H8O144.2
dDuloxetine EP Impurity G1-Fluoronaphthalene321-38-0C10H7F146.2
en-Nitroso Duloxetine (S)-N-methyl-N-(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)nitrous amide.2680527-91-5 C18H18N2O2S326.4
f1-NaphthylamineNaphthalene-1-amine 134-32-7 C10H9N143.19
g1-(thiophen-2-yl)ethanone1-(thiophen-2-yl)ethanone88-15-3C6H6OS126.17
46Dicycloverine impurities
aDicycloverine EP Impurity A[1,1'-Bi(cyclohexane)]-1-carboxylic acid0263-54-9C13H22O2210.3
bDicycloverine Impurity 1Bicyclohexyl92-51-3 C12H22166.3
47Felodipine impurities
aFelodipine RS3-Ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate72509-76-3C18H19Cl2NO4384.3
bFelodipine EP Impurity A3-Ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate96382-71-7C18H17Cl2NO4382.2
cFelodipine EP Impurity BDimethyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate91189-59-2 C17H17Cl2NO4370.2
dFelodipine EP Impurity CDiethyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate79925-38-5C19H21Cl2NO4398.3
eFelodipine Impurity 1Methyl 2-(2,3-dichlorobenzylidene)-3-oxobutanoate74073-22-6C12H10Cl2O3273.1
fN-Nitroso-Felodipine3-Ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1-nitroso-1,4-dihydropyridine-3,5-dicarboxylate;N/A C18H18Cl2N2O5413.3
48Famotidine Impurities
aFamotidine Impurity A3-[[[2-[(Diaminomethylidene)amino]thiazol-4-yl]methyl]sulfanyl]propanimidamide124646-10-2C8H14N6S2258.36
49Glycopyrronium Bromideimpurities
aGlycopyrronium Bromide EP Impurity B2-Oxo-2-phenylacetic acid611-73-4C8H6O3150.1
bGlycopyrronium Bromide EP Impurity C2-Hydroxy-2-phenylacetic acid90-64-2 C8H8O3152.2
cGlycopyrronium Bromide EP Impurity DBenzoic acid65-85-0 C7H6O2122.1
dGlycopyrronium Bromide EP Impurity FBenzaldehyde100-52-7C7H6O106.1
eGlycopyrronium Bromide EP Impurity HMethyl 2-oxo-2-phenylacetate15206-55-0C9H8O3164.2
fGlycopyrronium Bromide EP Impurity K2-Cyclopentyl-2-phenylacetic acid3900-93-4C13H16O2204.3
gGlycopyrronium Bromide EP Impurity MCyclopentyl(phenyl)methanone5422-88-8C12H14O174.2
hGlycopyrronium Bromide EP Impurity O5-Nitroisophthalic acid618-88-2C8H5NO6211.1
iGlycopyrronium Bromide EP Impurity G1-Methylpyrrolidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate hydrochloride13118-10-0C18H25NO3 : HCl303.4 : 36.5
jGlycopyrronium Bromide EP Impurtiy J and enantiomeralpha-Cyclopentylmandelic Acid427-49-6C13H16O3220.3
kGlycopyrronium Bromide EP Impurity L and enantiomerMethyl 2-cyclopentyl-2-hydroxy-2-phenylacetate19833-96-6C14H18O2218.3
50Gabapentin Impurities
aGabapentin EP Impurity A2-Azaspiro[4.5]decan-3-one64744-50-9 C9H15NO153.2
51Hydroxyzine
aHydroxyzine impurity A1-((4-Chlorophenyl)(phenyl)methyl)piperazine303-26-4C17H19ClN2286.8
bHydroxyzine impurity B2-(2-(4-Benzhydrylpiperazin-1-yl)ethoxy)ethanol hydrochloride1263283-80-2C21H29ClN2O2376.92
52Levomepromazine Impurity
aLevomepromazine Maleate RSN/A7104-38-3C19H24N2OS : C4H4O4328.5 : 116.1
bLevomepromazine EP Impurity A2-Methoxyphenothiazine1771-18-2 C13H11NOS229.3
cReagennt3-Chloro-N,N,2-trimethylpropan-1-amine hydrochloride4261-67-0C6H14ClN135.6
dLevomepromazine EP Impurity B10-[(2R)-3-(Dimethylamino)-2-methylpropyl]-2-methoxy-5λ4 -phenothiazin-5(10H)-one7606-29-3C19H24N2O2S344.5
eLevomepromazine EP Impurity C (n-desmethyl levomepromazine)(2R)-3-(2-Methoxy-10H-phenothiazin-10-yl)-N,2-dimethylpropan-1-amine37819-98-0C18H22N2OS314.4
53Levonorgestrel Impurity
aLevonorgestrel - Impurity M6(7)-Dehydro Norgestrel51087-61-7C21H26O2310.43
54Loperamide Impurity
aLoperamide N-Oxide4-(4-Chlorophenyl)-1-(4-(dimethylamino)-4-oxo-3,3-diphenylbutyl)-4-hydroxypiperidine 1-oxide;217471-03-9C29H33ClN2O3493.04
55Linagliptin impurity
aLinagliptin S isomer(S)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione668270-11-9N/AN/A
bN-BOC impurity of Linagliptin(R)-tert-Butyl (1-(7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-2,6-dioxo-2,3,6,7-tetrahydro-1H-purin-8-yl)piperidin-3-yl)carbamate668273-75-4N/AN/A
56Liothyronine Impurities
aLiothyronine EP Impurity AO-(4-Hydroxy-3, 5-diiodophenyl)-3, 5-diiodo-L-tyrosine51-48-9C₁₅H₁₁I₄NO₄776.87
bLiothyronine EP Impurity C2-(4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl)acetic acid51-24-1C14H9I3O4621.9
cLiothyronine EP Impurity D
dLiothyronine EP Impurity E(S)-2-Amino-3-(4-(4-hydroxyphenoxy)-3,5-diiodophenyl)propanoic acid1041-01-6 C15H13I2NO4525.1
57Methotrexate Impurities
aMethotrexate EP Impurity A(2,4-Diaminopteridin-6-yl)methanol945-24-4C7H8N6O192.1
bMethotrexate EP Impurity CN-methylfolic Acid; Methopterine; (2S)-2-[[4-[[(2-amino-4-hydroxypteridin-6-yl)methyl]methylamino]benzoyl]amino]pentanedioic Acid2410-93-7C20H21N7O6455.42
cMethotrexate EP Impurity D4-(((2-Amino-4-oxo-3,4-dihydropteridin-6-yl)methyl)(methyl)amino)benzoic acid5623-18-7C15H14N6O3326.3
dMethotrexate EP Impurity E4-(((2,4-Diaminopteridin-6-yl)methyl)(methyl)amino)benzoic acid19741-14-1C15H15N7O2325.3
58Mebeverine Impurities
aMebeverine EP- Impurity -A4-Methoxyphenylacetone122-84-9C10H12O2164.2
bMebeverine EP- Impurity -BN/A14367-46-5C12H19NO193.3
cMebeverine EP- Impurity -CMebeverine metabolite Mebeverine alcoho14367-47-6C16H27NO2265.4
dMebeverine EP- Impurity -D3,4-Dimethoxybenzoic acid93-07-2 C9H10O4182.2
59Metformin Impurities
aMetformin HCl WRS1,1-Dimethylbiguanide Hydrochloride1115-70-4 C4H11N5 : HCl129.2 : 36.5
cMetformin EP Impurity AN-Cyanoguanidine,461-58-5C2H4N484.1
dMetformin EP Impurity D1,3,5-Triazine-2,4,6-triamine108-78-1C3H6N6126.12
60Melatonin Impurities
aMelatonin N-(2-(5-Methoxy-1H-indol-3-yl)ethyl)acetamide73-31-4C13H16N2O2232.3
bMelatonin EP Impurity AN/A50-67-9 C10H12N2O : HCl 176.2 : 36.5
cMelatonin EP Impurity BN-(2-(5-Hydroxy-1H-indol-3-yl)ethyl)acetamide1210-83-9C12H14N2O2218.3
dMelatonin EP Impurity CN/A608-07-1C11H14N2O190.2
eMelatonin EP Impurity DN-acetyl-5-acetoxytryptamine28026-16-6C14H16N2O3260.3
fMelatonin Impurity-12-(5-Methoxy-1H-indol-3-yl)acetonitrile2436-17-1 C11H10N2O186.2
61Midodrine Impurities
aMidodrine USP Related Compound A2-amino-1-(2,5-dimethoxyphenyl)ethan-1-ol60407-53-6C10H15NO3 : HCl 197.2 : 36.5
bRM1,4-Dimethoxybenzene150-78-7C10H8O2138.7
62Meclizine Impurity
aMeclizine Impurity B4-Chlorobenzhydrol (4- CBH)119-56-2C13H11ClO218.7
63Nicardipine Impurities
aNicardipine Related compound- B (Nicardipine Pyridine analog)3-{2-[Benzyl(methyl)amino]ethyl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate, Hydrochloride1216817-27-4C26H27N3O6 .HCl513.97
64Pregabalin Impurities
aPregabalin Impurity-A(S)-4-Isobutylpyrrolidin-2-one,181289-23-6C8H15NO141.2
bPregabalin Impurity-B (USP Related Compound-A)(3R)-3-(Aminomethyl)-5-methylhexanoic Acid148553-51-9C8H17NO2159.2
cPregabalin Impurity-C (USP impurity)Mendalic Acid (2-Hydroxy-2-phenylacetic acid)90-64-2C8H8O3152.2
dPregabalin Impurity-DIsopropyl 2-hydroxy-2-phenylacetate4118-51-8C11H14O3194.2
ePregabalin Impurity-1 (USP impurity)Isobutylglutarmonoamide (3-(2-Amino-2-oxoethyl)-5-methylhexanoic acid)181289-15-6C9H17NO3187.2
fPregabalin Impurity-2 (USP impurity) (Isobutylglutaric acid)3-Isobutylpentanedioic acid75143-89-4C9H16O4188.2
gPregabalin Related compound-C4-Isobutylpyrrolidin-2-one61312-87-6C8H15NO141.2
65Paracetamol Impurities
aParacetamol RSAcetaminophen103-90-2C8 H9 N O2151.16
bParacetamol EP Impurity AN-(2-Hydroxyphenyl)acetamide614-80-2C8H9NO2151.2
cParacetamol EP Impurity BN-(4-Hydroxyphenyl)propanamide 1693-37-4C9H11NO2165.2
dParacetamol EP Impurity CN-(3-Chloro-4-hydroxyphenyl)acetamide3964-54-3C8H8ClNO2185.6
e Paracetamol EP Impurity DN-Phenyl acatamide 103-84-4C8H9NO135.16
f Paracetamol EP Impurity E4'-Hydroxyacetophenone99-93-4C8H8O2136.2
gParacetamol EP Impurity F4-Nitrophenol 100-02-7C6H5NO3139.11
hParacetamol EP Impurity G1-(4-Hydroxyphenyl)ethanone oxime34523-34-7C8H9NO2151.2
iParacetamol EP Impurity H4-Acetamidophenyl acetate2623-33-8C10H11NO3193.2
jParacetamol EP Impurity IN-(5-acetamido-2-hydroxyphenyl)-N-(4-hydroxyphenyl)acetamide118-93-4C8H8O2136.2
kParacetamol EP Impurity JN-(4-Chlorophenyl)acetamide (4-chloroacetanilide )539-03-7C8H8ClNO169.6
lParacetamol EP Impurity KP- Aminophenol ,1-Amino-4-hydroxy benzene123-30-8 C6H7NO109.1
66Telmisartan impurities
aTelmisartan Related Compound-A/ Telmisartan Impurity-A2-n-Propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazole Monohydrate 1282554-35-1C19H20N4.H2O322.41
67Zolidronic acid impurities
aImidazole acetic acid 2-(1H-Imidazol-1-yl)acetic acid22884-10-4C5H6N2O4128.1