Ezetimibe desfluoro methyl impurity

Ezetimibe desfluoro methyl impurity product with CAS: 1700622-07-6 is also known as (3R,4S)-1-(4-Fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-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 Ezetimibe impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (3R,4S)-1-(4-Fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.