Simvastatin EP Impurity A
| CAS No. | : 101314-97-0 |
| Mol F. | : C25H39NaO6 |
| Mol W. | : 458.56 |
| Cat No. | : SA32401 |
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Description
| Product Name | Simvastatin EP Impurity A |
| Synonyms | Simvastatin USP Related Compound A
Simvastatin Hydroxy Acid Sodium Salt Tenivastatin Sodium Salt |
| Related API | Simvastatin |
| Category | Impurities |
Simvastatin EP Impurity A product with CAS: 101314-97-0 is also known as Simvastatin USP Related Compound A. 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 USP Related Compound A 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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