Ring opened ezetimibe impurity

Ring opened ezetimibe impurity product with CAS: 1197811-72-5 is also known as 2-(4-Hydroxybenzyl)-N,5-bis-(4-fluorophenyl)-5-hydroxypentanamide. 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, 2-(4-Hydroxybenzyl)-N,5-bis-(4-fluorophenyl)-5-hydroxypentanamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.