Palonosetron Hydrochloride nitrosamine impurity

Palonosetron Hydrochloride nitrosamine impurity product with CAS: NA is also known as N-((R)-1-phenylethyl)-N-((S)-quinuclidin-3-yl)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, N-((R)-1-phenylethyl)-N-((S)-quinuclidin-3-yl)nitrous amide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.