Ezetimibe Impurity B; methyl 5-(4-fluorophenyl)-5-oxopentanoate

Ezetimibe Impurity B; methyl 5-(4-fluorophenyl)-5-oxopentanoate product with CAS: 1368310-60-4 is also known as Ezetimibe EP Impurity B. 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, Ezetimibe EP Impurity B is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.