Ezetimibe Tetrahydropyran Impurity

Ezetimibe Tetrahydropyran Impurity product with CAS: 1296129-15-1; 1050631-82-7 is also known as (2R,3R,6S)-N,6-Bis(4-fluorophenyl)tetrahydro-2-(4-hydroxyphenyl)-2H-pyran-3-carboxamide. 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, (2R,3R,6S)-N,6-Bis(4-fluorophenyl)tetrahydro-2-(4-hydroxyphenyl)-2H-pyran-3-carboxamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.