Simvastatin EP Impurity B
CAS No. | : 145576-25-6 |
Mol F. | : C27H40O6 |
Mol W. | : 460.6 |
Cat No. | : SA32402 |
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Description
Product Name | Simvastatin EP Impurity B |
Synonyms | Simvastatin USP Related Compound B
Simvastatin Acetate Ester (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(acetyloxy)-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate |
Related API | Simvastatin |
Category | Impurities |
Simvastatin EP Impurity B product with CAS: 145576-25-6 is also known as Simvastatin USP Related Compound B. 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 B 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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