Simvastatin EP Impurity K
| CAS No. | : NA |
| Mol F. | : C25H40O5 |
| Mol W. | : 420.58 |
| Cat No. | : SA32411 |
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Description
| Product Name | Simvastatin EP Impurity K |
| Synonyms | 4α,5-Dihydro Simvastatin
(1S,3S,4aR,7S,8S,8aS)-8-(2-((2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,4,4a,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate |
| Related API | Simvastatin |
| Category | Impurities |
Simvastatin EP Impurity K product with CAS: NA is also known as 4α,5-Dihydro 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, 4α,5-Dihydro 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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