Description

Nitrosamine impurity of Atorvastatin Calcium product with CAS: NA is also known as (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-4-(nitroso(phenyl)carbamoyl)-3-phenyl-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid. 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 Nitrosamine impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-4-(nitroso(phenyl)carbamoyl)-3-phenyl-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid 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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