(N-1) of 3′-deshydroxy ezetimibe acid

(N-1) of 3′-deshydroxy ezetimibe acid product with CAS: NA is also known as (R)-methyl 5-(4-fluorophenyl)-2-((S)- (4-fluorophenylamino)(4- hydroxyphenyl)methyl)pentanoate. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. (N-1) of 3′-deshydroxy ezetimibe acid is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Ezetimibe and its related formulations. Moreover, (R)-methyl 5-(4-fluorophenyl)-2-((S)- (4-fluorophenylamino)(4- hydroxyphenyl)methyl)pentanoate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.