Simvastatin Dihydro Diol Impurity
| CAS No. | : 159143-77-8 |
| Mol F. | : C25H40O7 |
| Mol W. | : 452.58 |
| Cat No. | : SA32417 |
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Description
| Product Name | Simvastatin Dihydro Diol Impurity |
| Synonyms | 3’,5’-Dihydro Diol Simvastatin
[1S-[1α,3α,4β,6α,7β,8β(2S*,4S*),8aβ]]-Butanoic Acid 2,2-Dimethyl-1,2,3,4,6,7,8,8a- octahydro-4,6-dihydroxy-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl) ethyl]-1-naphthalenyl ester |
| Related API | Simvastatin |
| Category | Impurities |
Simvastatin Dihydro Diol Impurity product with CAS: 159143-77-8 is also known as 3’,5’-Dihydro Diol 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’,5’-Dihydro Diol 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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