Isoleucine Valsartan

Isoleucine Valsartan product with CAS: 137862-78-3 is also known as N-(1-Oxopentyl)-N-[[2’-(2H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Isoleucine. 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, N-(1-Oxopentyl)-N-[[2’-(2H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Isoleucine is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.