N-Nitroso Palbociclib 1

N-Nitroso Palbociclib 1 product with CAS: NA is also known as 6-acetyl-8-cyclopentyl-5-methyl-2-((5-(4-nitrosopiperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one. 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 Palbociclib impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 6-acetyl-8-cyclopentyl-5-methyl-2-((5-(4-nitrosopiperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.