4-desfluoro N-Boc methyl ester Impurity
CAS No. | : NA |
Mol F. | : C16H21F2NO4 |
Mol W. | : 329.34 |
Cat No. | : SA10447 |
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Description
Product Name | 4-desfluoro N-Boc methyl ester Impurity |
Synonyms | (R)-Methyl 3-(tert-butoxycarbonylamino)-4-(2,5-difluorophenyl)butanoate |
Related API | Sitagliptin |
Category | Impurities |
4-desfluoro N-Boc methyl ester Impurity product with CAS: NA is also known as (R)-Methyl 3-(tert-butoxycarbonylamino)-4-(2,5-difluorophenyl)butanoate. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. 4-desfluoro N-Boc methyl ester Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (R)-Methyl 3-(tert-butoxycarbonylamino)-4-(2,5-difluorophenyl)butanoate 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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