(N-1) of 3′-deshydroxy ezetimibe acid
| CAS No. | : NA |
| Mol F. | : C25H25F2NO3 |
| Mol W. | : 425.47 |
| Cat No. | : SA14853 |
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Description
| Product Name | (N-1) of 3′-deshydroxy ezetimibe acid |
| Synonyms | (R)-methyl 5-(4-fluorophenyl)-2-((S)- (4-fluorophenylamino)(4- hydroxyphenyl)methyl)pentanoate |
| Related API | Ezetimibe |
| Category | Impurities |
(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.
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