Simvastatin EP Impurity N
| CAS No. | : 774611-54-0 |
| Mol F. | : C26H40O5 |
| Mol W. | : 432.59 |
| Cat No. | : SA32413 |
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Description
| Product Name | Simvastatin EP Impurity N |
| Synonyms | 2-Methyl Simvastatin
2,2-Dimethyl-(1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-5-methyl-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl ester butanoic acid |
| Related API | Simvastatin |
| Category | Impurities |
Simvastatin EP Impurity N product with CAS: 774611-54-0 is also known as 2-Methyl Simvastatin. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Simvastatin impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 2-Methyl Simvastatin is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.
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