API Impurities


impurities list of API molecules
11.

Atazanavir

(2S,3S)-1-((E)-1-(4-(Pyridin-2-yl)benzyl)-2-(4-(pyridin-2-yl)benzylidene)hydrazinyl)-3-amino-4-phenylbutan-2-ol

 

impurity C

12.

Atazanavir

(2S,3S)-1-(1-(4-(Pyridin-2-yl)benzyl)hydrazinyl)-3-amino-4-phenylbutan-2-ol trihydrochloride

 

Imp-J

13. 

Atomoxetin.HCl

(R)-N-Methyl-3-phenoxy-3-phenylpropan-1-amine

 

EP Imp-A
(Desmethyl imp)

14. 

Atorvastatin

(3R,5R)-7-[5-(4-Fluorophenyl)-3-isopropyl-2-oxo-4-phenyl-3-(phenylcarbamoyl)-2,3-dihydro
-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid.

 

USP
pyrrolidone analog

15 

Atorvastatin

3R,5R)-Methyl 7-(3-(phenylcar
bamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1Hpyrrol-1-yl)-3,5-dihydroxyheptanoate

345891-62-5

Methyl ester

16. 

Atorvastatin

(3S,5S)-7-(3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1Hpyrrol-1-yl)-3,5-dihydroxyheptanoic acid

 

Enantiomer

17. 

Atorvastatin

(3R,5R)-7-(3-(Phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl)-3,5-dihydroxy
heptanoic acid

433289-83-9

Desfluoro

18. 

Atorvastatin

 

N/A

Toluene analog

19. 

Atorvastatin

3S,5R)-7-(3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-
2-isopropyl-4-phenyl-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic
Acid

N/A

Diastereomer

20. 

Atorvastatin

Difluoro impurity

N/A

 

21. 

Atorvastatin

3-(4-Fluorobenzoyl)-2-(2-methyl-1-oxopropyl)-N,3-diphenyloxiranecarboxamide

148146-51-4

Epoxide  EP IMP-D

22. 

Acyclovir

 

Aceticacid 2-(2-amino-6-oxo-1,6-dihydro-purin-9-ylmethoxy)
-ethyl ester

N/A

EP Imp-A
(Valacyclovir EP Imp-I)

23. 

Atovaquone

2-((1r,4r)-4-(4-Chlorophenyl)
cyclohexyl)-3-oxo-3H-indene-1-carboxylic acid

 

EP Imp-A
(USP Indene isomer)

24. 

Atovaquone

2-((1s,4s)-4-(4-Chlorophenyl)
cyclohexyl)-3-hydroxy
naphthalene-1,4-dione

 

USP RC – A
(EP Imp-B)

25. 

Atovaquone

2-((1r,4r)-4-(4-Chlorophenyl)
cyclohexyl)-3-methoxynaphthalene-1,4-dione

 

EP Imp-D
(USP methoxy atovaquone)

26 

Aripiprazole

7-(4-Bromobutoxy)-3,4-dihydroquinolin-2(1H)-one

129722-34-5

 

Bromo impurity

27. 

Aripiprazole

 

N/A

Bis imp

28. 

Aripiprazole

7-(4-(4-(2,3-Dichlorophenyl)
piperazin-1-yl)butoxy)-1-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butyl)-3,4-dihydroquinolin-2(1H)-one

N/A

Dimer imp

29. 

Aripiprazole

7-(4-(4-(2,3-Dichlorophenyl)
piperazin-1-yl)butoxy)quinolin-2(1H)-one

129722-25-4

Imp-E
(USP RC-G)

30. 

Aripiprazole

7-(4-(4-(2-Chlorophenyl)
piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one

N/A

Imp-C

31. 

Ariprazole

7-(4-(4-(3-Chlorophenyl)
piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one

203395-82-8

Imp-D

32. 

Aliskrine

N-(2-(2-Cyano-2-methylpropyl
carbamoyl)-2-methylpropyl)-7-(3-(3-methoxypropoxy)-4-methoxy
benzyl)-5-azido-4-hydroxy-2-isopropyl-8-methylnonanamide

 

imp

33. 

Ambrisentan

2-(2,2-Diphenylvinyloxy)-4,6-dimethylpyrimidine

N/A

Decarboxylated Impurity