Valsartan Descarboxylic acid diazirine impurity

Valsartan Descarboxylic acid diazirine impurity product with CAS: NA is also known as 1-[({2.3-Diazatetracyclo[9.4.0.02,4.05,10]pentadeca-1(11),5,7,9,12,14-hexaen-14-yl}methyl)(isobutyl)amino]-1-pentanone. 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 Valsartan impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 1-[({2.3-Diazatetracyclo[9.4.0.02,4.05,10]pentadeca-1(11),5,7,9,12,14-hexaen-14-yl}methyl)(isobutyl)amino]-1-pentanone is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.