Ezetimibe Diacid Impurity

Ezetimibe Diacid Impurity product with CAS: 1013025-04-1 is also known as (2R)-2-[(S)-[(4-Fluorophenyl)amino][4-(phenylmethoxy)phenyl]methyl]pentanedioic Acid. 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 Ezetimibe impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (2R)-2-[(S)-[(4-Fluorophenyl)amino][4-(phenylmethoxy)phenyl]methyl]pentanedioic Acid is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.