Rilpivirine Hydrochloride nitrosamine impurity

Rilpivirine Hydrochloride nitrosamine impurity product with CAS: NA is also known as (E)-N-(2-((4-cyanophenyl)amino)pyrimidin-4-yl)-N-(4-(2-cyanovinyl)-2,6-dimethylphenyl)nitrous amide. 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, (E)-N-(2-((4-cyanophenyl)amino)pyrimidin-4-yl)-N-(4-(2-cyanovinyl)-2,6-dimethylphenyl)nitrous amide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.