Ezetimibe Dehydoxy Impurity

Ezetimibe Dehydoxy Impurity product with CAS: 204589-58-2 is also known as (3R,4S)-1-(4-Fluorophenyl)-3-[3-(4-fluorophenyl)propyl]-4-(4-hydroxyphenyl)-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)-1-(4-Fluorophenyl)-3-[3-(4-fluorophenyl)propyl]-4-(4-hydroxyphenyl)-2-azetidinone is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.