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- Synonyms:Tenivastatin Sodium Salt
- Chemical Name:sodium;(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
- Country of Origin:India
- Application Notes:Impurity in commercial preparations of Simvastatin
- Product Category:Simvastatin Impurities
Simvastatin EP Impurity A is identified by CAS No. 101314-97-0 and is chemically known as Tenivastatin Sodium Salt, IUPAC Name: sodium;(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate.
Simvastatin EP Impurity A is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Simvastatin.
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