Simvastatin Acid Methyl Ester
| CAS No. | : 145576-26-7 |
| Mol F. | : C26H42O6 |
| Mol W. | : 450.61 |
| Cat No. | : SA32415 |
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Description
| Product Name | Simvastatin Acid Methyl Ester |
| Synonyms | (3R,5R)-Methyl 7-((1S,2S,6R,8S)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoate |
| Related API | Simvastatin |
| Category | Impurities |
Simvastatin Acid Methyl Ester product with CAS: 145576-26-7 is also known as (3R,5R)-Methyl 7-((1S,2S,6R,8S)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoate. 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, (3R,5R)-Methyl 7-((1S,2S,6R,8S)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoate 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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