Impurities

Pharmabridge :Impurities

Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredient (API) or develop during formulation or storage. These may arise from raw materials, manufacturing processes, degradation, or contamination. Controlling impurities is essential to ensure the safety, efficacy, and stability of medicines. Regulatory agencies like the WHO, FDA, and EMA set strict guidelines for identifying, quantifying, and controlling impurities in both APIs and finished products. Pharmabridge supports efforts to enhance impurity management by promoting knowledge sharing, training, and collaboration among pharmacists, manufacturers, and regulators, especially in low- and middle-income countries. By improving awareness and technical capacity to monitor impurities, Pharmabridge helps ensure access to high-quality, safe medicines worldwide, contributing to better global health outcomes.

Impurity Standard List
       
Sr. No Chemical Name CAS No. Product name
1 2-Methyl-3-nitrobenzoic Acid Methyl Ester, 3-Nitro-o-toluic Acid Methyl Ester, Methyl 3-nitro-o -toluate 59382-59-1 Lenalidomide
2 2,4-Diaminopteridine-6-methanol; Methotrexate EP Impurity A 945-24-4 Methotrexate
3 2,4-Diamino-6-chloromethylpteridine;6-(Chloromethyl)-2,4- pteridinediamine 57521-63-8 Methotrexate
4 Methyl 2-(Bromomethyl)-3-nitrobenzoate; 2-(Bromomethyl)-3-nitro-benzoic acid methyl ester; Lenalidomide Impurity B (IP) 98475-07-1 Lenalidomide
5 3-Nitro-2-methylbenzoic acid; 3-nitro-o-toluic acid 1975-50-4 Lenalidomide
6 Lenalidomide Impurity A(IP ); 3-Amino-2,6-piperidinedione hydrochloride; 2,6-dioxopiperidine -3-ammonium chloride; 3- Aminopiperidine-2,6-dione hydrochloride 24666-56-6 Lenalidomide
7 Lenalidomide Impurity C (IP); 3-(4-Nitro-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6- dione; 3-(7-nitro-3-oxo-1H-isoindol-2-yl)piperidine-2,6-dione 827026-45-9 Lenalidomide
8 5-Aminoimidazole-4-carboxamide 4-Amino-1H-imidazole-5-carboxamide Dacarabzine Impurity B (IP/BP) 72-40-2 Dacarbazine
9 N,N’-Carbonyldiimidazole di(1H-imidazol-1-yl)methanone 530-62-1 Lenalidomide
10 Cytosine Riboside 1-ß-D-ribosylcytosine 65-46-3 Cytarabine
11 6-Amino-2(1H)-pyramidinone              ( USP) 71-30-7 Cytarabine
12 Pyrimidine-2,4(1H,3H)-dione (USP) 66-22-8 Cytarabine
13 (2R,3R,3aS,9aR)-2-(Hydroxymethyl)-6-imino-2,3,3a,9a- tetrahydro-6H-furo[2′,3′:4,5]oxazolo[3,2-  a]pyrimidin-3-ol ( USP) 10212-25-6 Cytarabine
14 Hydrocortisyl;Hydrocortone;Cortisol 50-23-7 Hydrocortisone Hemisuccinate
15 5-Thiazolecarboaxamide,2-amino-N-(2-chloro-6-methylphenyl);2- amino-n-(2-chloro-6-methylphenyl)-5-thiazolecarboxamide 302964-24-5 Dasatinib
16 2-methyl-4,6-dichloropyrimidine 1780-26-3 Dasatinib
17 (N-(4-methyl-3-((4-(pyridin-3-yl)-pyrimidin-2-yl)amino)phenyl)-4 ((4-methylpiperazin-1-yl)methyl)benzamide 152459-95-5 Imatinib Mesylate
18 7-Methoxy-6-(3-morpholinopropoxy)quinazolin-4(3H)-one) 199327-61-2 Gefitinib
19 4-amino-1,3,5-triazin-2(1H)-one 931-86-2 Azacitidine
20 17-(Pyridin-3-yl)androsta-5,16-dien-3β-ol (as per USP & IP); 7- Keto Abiraterone Acetate; (3β)-17-(3-Pyridinyl)androsta-5,16- dien-3-ol; Androsta-5,16-dien-3-ol. 154229-19-3 Abiraterone acetate
21 (3S,8R,9S,10R,13S,14S)-17-iodo-10,13-dimethyl- 2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta(a)phenanthren- 3-ol 32138-69-5 Abiraterone acetate
22 3-Quinuclidinol I-Form;(3r)-quinuclidin-3-ol 25333-42-0 Solifenacin
23 6-Nitro-1H-indazole;6-Nitro-2H-indazole 7597-18-4 Axitnib
24 Isophthalic Acid 121-91-5 Isophthalic Acid
25 1,3-Dihydroxidimethyl Ketone 96-26-4 Methotrexate
26 2-methyl-3-aminobenzoic acid,3-amino-o-toluic acid 52130-17-3 Nilotinib
27 Diacerin 481-72-1 Diacerin
28 1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one; 9-Methyl-1,2,3,9 Tetrahydro-4H-carbazol-4-one; N-methyl carbazolone 27387-31-1 Ondanserton
29 1-Oxa-4-azacycloheaxane;Diethylene Oximide;Tetrahydro-1,4- oxazine 110-91-8 Molsidomine
30 10-Deacetylbaccatin III (USP), 10-DAB III 32981-86-5 Paclitaxel
31 Baccatin III (Paclitaxel EP Impurity N) 27548-93-2
32 Impurity 3: Paclitaxel Photo degradant (Paclitaxel-8-Hydro- Bicyclo(3.3.0)octane, Pentacyclic taxol isomer 146139-03-9
33 Impurity 4: 10-Deacetylpaclitaxel (Paclitaxel EP Impurity G) 78432-77-6
34 2-Debenzoylpaclitaxel-2-pentenoate(Paclitaxel EP Impurity A) 173101-54-7
35 Oxetane ring opened,acetyl and benzoyl (X1)(Paclitaxel EP Impurity 932042- 85-8  
36 10- Acetoacetyl-paclitaxel(X2)(Paclitaxel EP Impurity J) 2757197-26-3
37 10-deacetyl-7-epipaclitaxel(X3)(Paclitaxel EP Impurity H) 78454-17-8
38 7-Epi-Paclitaxel(Paclitaxel EP Impurity E) 105454-04-4
39 10,13-Bissidechainpaclitaxel(Paclitaxel EP Impurity I) (10,13-bis(branched chains)paclitaxel) 2157462-42-3
40 7-Acetylpaclitaxel(Paclitaxel EP Impurity L) 7-O-Acetylpaclitaxel 92950-39-5
41 Paclitaxel 13-Tes-Baccatin III 208406-86-4
42 7-O-(Triethylsilyl)paclitaxel(Paclitaxel EP Impurity K ) Paclitaxel impurity K (7-O-(Triethylsilanyl)paclitaxel, 7-O- (Triethylsilyl)taxol) 148930-55-6
43 Albendazole EP Impurity A 80983-36-4 Albendazole
44 Albendazole EP Impurity B 54029-12-8
45 Albendazole EP Impurity C 75184-71-3
46 Albendazole EP Impurity D 80983-34-2
47 Albendazole EP Impurity E 10605-21-7
48 Triacetyl aloe-emodin 25395-11-3 Aloe-emodin
49 Abiraterone acetate N-oxide 2517964-85-9 Abiraterone acetate
50 Aceclofenac EP Impurity B 15307-78-5 Aceclofenac
51 Aceclofenac EP Impurity C 15307-77-4
52 Aceclofenac EP Impurity D 139272-66-5
53 Aceclofenac EP Impurity E 139272-67-6
54 Aceclofenac EP Impurity F 100499-89-6