Ezetimibe Diacetate

Ezetimibe Diacetate product with CAS: 163380-20-9 is also known as (3R,4S)-3-[(3S)-3-(Acetyloxy)-3-(4-fluorophenyl)propyl]-4-[4-(acetyloxy)phenyl]-1-(4-fluorophenyl)-2-azetidinone. 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, (3R,4S)-3-[(3S)-3-(Acetyloxy)-3-(4-fluorophenyl)propyl]-4-[4-(acetyloxy)phenyl]-1-(4-fluorophenyl)-2-azetidinone is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.