1,2-Seco-ezetimibe-δ-lactone

1,2-Seco-ezetimibe-δ-lactone product with CAS: NA is also known as (3R,6S)-6-(4-Fluorophenyl)-3-((S)-((4-fluorophenyl)amino)(4-hydroxyphenyl)methyl)tetrahydro-2H-pyran-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,6S)-6-(4-Fluorophenyl)-3-((S)-((4-fluorophenyl)amino)(4-hydroxyphenyl)methyl)tetrahydro-2H-pyran-2-one is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.