List of Impurities
Drug Name Designation/Chemical Name
Aceclofenac Eethyl {2-[(2,6-dichlorophenyl)amino]phenyl}acetate
Methyl {2-[(2,6-dichlorophenyl)amino] phenyl}acetate
2-Ethoxy-2-oxoethyl {2-[(2,6-dichlorophenyl) amino]phenyl}acetate
2-Methoxy-2-oxoethyl {2-[(2,6-dichlorophenyl) amino]phenyl}acetate
1-(2,6-dichlorophenyl)-1,3-dihydro-2H-indol-2-one
Albendazole Impurity A: 5-(Propylsulfanyl)-1H-benzimidazol-2- amine
Impurity B: Methyl [5-(propylsulfinyl)-1H- benzimidazol-2-yl]carbamate
Impurity C: Methyl [5-(propylsulfonyl)-1H- benzimidazol-2-yl]carbamate
Impurity D: 5-(Propylsulfonyl)-1H-benzimidazol-2- amine Hydrobromide salt
Impurity E: Methyl 1H-benzimidazol-2-ylcarbamate
A-Oxibendazole
Amlodipine Methyl benzenesulfonate
Phthaloyl Amlodipine
Aripiprazole Impurities Aripiprazole N-oxide Impurity
Butoxy Impurity
Related Compound G
Impurity A
Impurity B (Piperazine impurity)
Impurity C
Impurity D
Impurity E (Dehydro impurity)
Impurity F
Dimer Impurity
Atorvastatin Atorvastatin Related compound D
Blonanserin 3-(4-methoxyphenyl)-3-oxopropanenitrile
3-(4-chlorophenyl)-3-oxopropanenitrile
3-Oxo-3-phenylpropanenitrile
4-Phenyl-5,6,7,8,9,10-hexahydrocycloocta [b]pyridin- 2(1H)-one
2-Chloro-4-(4-methoxyphenyl)-5,6,7,8,9,10- hexahydrocycloocta[b]pyridine
4-(4-methoxyphenyl)-5,6,7,8,9,10-hexahydro cycloocta[b]pyridin-2(1H)-one
4-(4-chlorophenyl)-5,6,7,8,9,10-hexahydro cycloocta[b]pyridin-2(1H)-one
Bupropion impurities Deschloro Bupropion
Bupropion dione derivative
o –Bupropion
List of Impurities
Drug Name Designation/Chemical Name
Chloropropiophenone
4-Chlorobupropion
5-Chlorobupropion
2-Bromo-3’- chloropropiophenone (Bromochloropropiophen one)
2-Bromo- (3-Chlorophenyl)-1-Propanone
m-Chlorobenzoic acid
3 – Chloro Benzoic Acid
Related Compound-A
Related Compound-B
Cephalexin A- Cephradine
Cetrizine hydrochloride Impurity A (USP)
Impurity B (USP)
Impurity C (USP)
Impurity D (USP)
Impurity G (USP)
Impurity K (USP)
Chlorphenamine maleate Impurities Chlorphenamine maleate Impurity-A
Chlorphenamine maleate Impurity-B
Chlorphenamine maleate Impurity-C
Cinnarizine 1-(Diphenylmethyl)piperazine  EP Impurity A
Ciprofloxacin Ciprofloxacin  Ethylenediamine analog
Clopidogrel Impurities Clopidogrel Impurity A
Clopidogrel Impurity B
Clopidogrel Impurity C
Decitanbine Impurity Mether ester
Deferasirox 4-[3,5-Bis-(2-hydroxyphenyl)[1,2,4]triazol-1-yl]benzoic acid methyl ester
4-[3,5-Bis-(2-hydroxyphenyl)[1,2,4]triazol-1-yl]benzoic acid ethyl ester
4-Hydrazinyl benzoic acid
Desipramine Imipramine Hydrochloride
10,11-Dihydro-5H-dibenzo[b,f]azepine
Desipramine carbamate
Dexamethasone Sodium Phosphate Impurity A
Impurity B
Impurity G
Dextromethorphan Hbr Dextromethorphan Impurity-A
Impurity B
Impurity C
3-methoxy morphinan
Dextromethorphan N-oxide impurity
Dipyridamol Impurity Impurity A
List of Impurities
Drug Name Designation/Chemical Name
Impurity B
Impurity C
Impurity D
Impurity E
Domperidone A-droperidol
Dutasteride Impurities Impurity A
Impurity B
Impurity C
Impurity E
Impurity F
Dihydro Dutasteride
β-isomer impurity
Escıtalopram Oxalate Desfluoro Impurıty
Etodolac Imp. A (EP): (1-ethyl-1,3,4,9-tetrahydropyrano[3,4- b]indol-1-yl)acetic acid
Imp. B (EP): (1-ethyl-8-methyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl)acetic acid
2-(7-Ethyl-1H-indol-3-yl)ethanol  or 7-Ethyl tryptophol
(8-Ethyl-1-methyl-1,3,4,9-tetrahydropyrano[3,4- b]indol-1-yl)acetic acid
Glyburide 5-Chloro-2-methoxy benzoic acid
5-Chloro-N-(2-phenylethyl)-2-methoxy benzamide
Compd. A: (5-Chloro-2-methoxy-N-[2-(4- sulfamoylphenyl)ethyl]benzamide
Imp. D: 1-Butyl-3-[[4-[2-[5-chloro-2- methoxybenzoyl)amino]ethyl]phenyl]sulfonyl urea
Hydrochlorothiazide Impurties Benzothiadiazine Related compound-A
Chlorothiazide
Hydrochlorothiazide working standard
Ibuprofen BP Ibuprofen impurity B
Imatinib 4-(4-Methylpiperazine-1-ylmethyl)benzoic acid Dihydrochloride
N-(5-amino-2-methylphenyl-4-(3-pyridyl)-2- pyrimidineamine
N-(4-Chloromethyl)phenyl)-4-methyl-3-(4-(pyridine-3- yl)pyrimidin-2-yl)amino)benzamide
N-(4-Methyl-3-((4-(pyridin-3-yl)-pyrimidin-2- yl)amino)phenyl)-4-(piperazin-1-yl-methyl)benzamide
4-(piperazin-1-ylmethyl)benzoic acid
Itraconazole impurities Itraconazole Impurity A (4-Methoxy derivative)
4-Triazolyl isomer
Propyl analogue
Isopropyl analogue
Itraconazole epimer
List of Impurities
Drug Name Designation/Chemical Name
N-Butyl isomer
Didioxolanyl analogue
Lerkanidipin HCl Impurities Lerkanidipin HCl I
Lerkanidipin HCl II
Lerkanidipin HCl III
Lercanidipine hydrochloride
Levodopa 3-(3,4-Dimethoxyphenyl)-L-alanine
Lurasidone Lurasidone Sulfoxide
Metaxalone 3,5 Xylenol (dimethylphenol)
Methyl paraben Methyl parahydroxybenzoate
Miconazole Nitrate A-Econazole Nitrate
Milnacipran 2-(chloromethyl)-N,N-diethyl-1-phenylcyclo propanecarboxamide
N,N-diethyl-2-(hydroxymethyl)-1-phenylcyclo propanecarboxamide
2-methyl-1H-isoindole-1,3(2H)-dione
Dimer
2-[(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)methyl]-N- ethyl-1-phenylcyclopropanecarboxamide
Pthalalimide
Cis- Lactone
DP-1
Moxifloxacin 8-Hydroxy
6,8-Dimethoxy
Decarboxy
Mycophenolate mofetil Mycophenolate mofetil N-oxide
Nateglinide Imp. G: Ethyl N-[[4-(1-methylethyl)cyclohexyl] carbonyl]-D-phenyl alninate
Imp. D: (2S)-2-amino-3-phenylpropionic acid
Olmesartan Medoxomil N-alkyl Impurity
Olefinic Impurity
Olmesartan
Related Compound A
Trityl Alcohol
Trityl Olmesartan
Olopatadine Olopatadine HCl WS
Olopatadine Related Compound B USP
Olopatadine Related Compound C USP
Omeprazole Omeprazole related compounds F&G mixture
5-methoxy-1H-benzimidazole-2-thiol
Ondansetron Ondansetron Impurity A
Paracetamol Acetamide  EP: Imp. D
List of Impurities
Drug Name Designation/Chemical Name
4-(acetylamino)phenyl acetate  EP: Imp. H
4-aminophenol  EP: Imp. K
Pemetrexed Methyl 4-bromobenzoate
3-Butyn-1-Ol
2,4-Diamino-6-Hydroxy pyrimidine
Pregabalin (3R)-3-(Aminomethyl)-5-methylhexanoic acid
( R )-Pregabalin
(3S)-3-(2-Amino-2-oxoethyl)-5-methylhexanoic acid
4-(2-Methylpropyl)pyrrolidin-2-one (Lactam)
Promethazine HCl impurities Promethazine impurity A
Promethazine impurity B
Promethazine impurity C
Promethazine impurity D
Iso- Promethazine hydrochloride
Sildenafil Imp. C: 5-[2-hydroxy-5-[(4-methylpiperazin-1- yl)sulfonyl]phenyl]-1-methyl-3-propyl-6,7-dihydro-1H- pyrazolo[4,3-d]pyrimidin-7-one
Solifenacin 1-phenyl-1,2,3,4-tetrahydroisoquinoline
Tadalafil Impurities Tadalafil Imp B (EP)
Tadalafil Imp C (EP)
Tadalafil Imp A
Telmisartan Impurity A (Related Compound A) – EP
Tenofovir Adenine impurity
Monoester impurity
Ethyl impurity
Isopropyl impurity
Dimer impurity
S-Isomer impurity
Chloromethyl Isopropyl Carbonate
9-(Prop-1-enyl)-9Hpurin-6-amine=WHO Imp-K
Tenovofir Disoproxil Fumarate Tenofovir Disoproksil Fumarate iPr-POC PMPA
Timolol Maleate impurities Impurity G
Iso timolol
3-morpholino-4-terbutoxy-1,2,5-thiadiazole
3-hydroxy-4-morpholino-1,2,5-thiadiazole
3-morpholino-4-chloro-1,2,5-thiadiazole
Tramadol Related Compound A (EP/USP)
Related Compound B (EP)
Impurity D
Tramadol HCl Impurities Tramadol HCl Impurity A
Tramadol HCl Impurity E
List of Impurities
Drug Name Designation/Chemical Name
Impurity A CIS-ISOMER
Impurity B
Impurity C
2-Dimethylaminomethyl-Cyclohexan – 1-one- hydrochloride
Impurity B: 2-[(Dimethylamino)methyl]cyclo hexanone hydrochloride (USP)
Tranexamic acid Tranexamic acid related compound D
Trazodon 3-Chloro-4-ethylaniline
Ziprasidone Ziprasidone Suloxide/Ziprasidone S-oxide
Zolpidem 2-[6-Methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin- 3-yl]acetamide
[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3- yl]acetic acid
[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3- yl]acetonitrile