Simvastatin EP Impurity I
| CAS No. | : 79902-42-4 |
| Mol F. | : C23H34O5 |
| Mol W. | : 390.51 |
| Cat No. | : SA32409 |
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Description
| Product Name | Simvastatin EP Impurity I |
| Synonyms | Simvastatin Methylpropanoyl Analog
Methylpropanoic acid [1S-[1α,3α,7β,8β(2S*,4S*),8aβ]]-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 EP Impurity I product with CAS: 79902-42-4 is also known as Simvastatin Methylpropanoyl Analog. 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, Simvastatin Methylpropanoyl Analog 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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