API
IMPURITY
CHEMICAL NAME
STRUCTURE
2
Simvastatin

EP Impurity A

(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-[(2,2-dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8ahexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid (hydroxy acid) Simvastatin-EP-Impurity-A
Simvastatin

EP Impurity B

(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(acetyloxy)-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate (acetate ester) Simvastatin-EP-Impurity-B
Simvastatin

EP Impurity C

(1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate (anhydrosimvastatin) Simvastatin-EP-Impurity-B
Simvastatin

EP Impurity C

(1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate (anhydrosimvastatin) Simvastatin-EP-Impurity-C
Simvastatin

EP Impurity E

(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2Hpyran- 2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2- methylbutanoate (lovastatin),
Simvastatin

EP Impurity G

(1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-3-methylene-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate Simvastatin-EP-Impurity-G
Simvastatin

Simvastatin Anhydro sodium salt

Simvastatin Anhydro sodium salt(IH)