Simvastatin beta-Hydroxy Impurity
| CAS No. | : 126313-98-2 |
| Mol F. | : C25H38O6 |
| Mol W. | : 434.57 |
| Cat No. | : SA32416 |
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Description
| Product Name | Simvastatin beta-Hydroxy Impurity |
| Synonyms | 3″-Hydroxy Simvastatin
3-Hydroxy-2,2-dimethylbutanoic acid 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester |
| Related API | Simvastatin |
| Category | Impurities |
Simvastatin beta-Hydroxy Impurity product with CAS: 126313-98-2 is also known as 3″-Hydroxy 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, 3″-Hydroxy 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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