Catégorie
Simvastatin
Numéro CAS
STD - 79902-63-9: IMP-A- 121009-77-6: IMP-B- 145576-25-6: IMP-C- 210980-68-0: IMP-D- 476305-24-5: IMP-E- 75330-75-5: IMP-G- 1449248-72-9: IMP-I-79902-42-4 :IMP-J- 864357-88-0
Formule moléculaire
STD - C25H38O5: IMP-A- C25H39O6: IMP-B- C27H40O6: IMP-C- C25H36O4: IMP-D- C50H76O10: IMP-E- C24H36O5: IMP-G- C25H36O5: IMP-I-C23H34O5 :IMP-J-C26H40O5
Masse moléculaire
STD - 418.6: IMP-A- 435.6: IMP-B- 460.6: IMP-C- 400.6 : IMP-D- 837.13: IMP-E- 404.5: IMP-G- 416.6: IMP-I-390.51 :IMP-J- 432.6
Synonyme

Simvastatin ((1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate)

Simvastatin EP Impurity A ((3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-[(2,2-dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid, Simvastatin USP Related Compound A)

Simvastatin EP Impurity B ((1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(acetyloxy)-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate, Simvastatin USP Related Compound 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, Simvastatin USP Related Compound C)

Simvastatin EP Impurity D ((2R,4R)-2-[2-[(1S,2S,6R,8S,8aR)-8-[(2,2-dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]ethyl]-6-oxooxan-4-yl(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-[(2,2-dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate, Simvastatin USP Related Compound D)

Simvastatin EP Impurity E ((1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate, Simvastatin USP Related Compound E)

Simvastatin EP Impurity G ((1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbut-3-enoate, Simvastatin USP Related Compound G)

Simvastatin EP Impurity I ((1S,3R,7S,8S)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl isobutyrate)

Simvastatin EP Impurity J  ((1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-methoxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate)

Simvastatin for System Suitability CRS is a pharmacopeial-grade certified reference standard used to assess the performance of chromatographic systems during the analysis of Simvastatin and its related substances. It is crucial for verifying parameters such as resolution, retention time, theoretical plates, and tailing factor to ensure method reliability in pharmaceutical quality control and regulatory compliance.