Saxagliptin N-Formyl Impurity
| CAS No. | : NA |
| Mol F. | : C19H25N3O3 |
| Mol W. | : 343.42 |
| Cat No. | : SA27403 |
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Description
| Product Name | Saxagliptin N-Formyl Impurity |
| Synonyms | (1S,3S,5S)-2-[(2S)-2-Formylamino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo [3.1.0] hexane-3-carbonitrile
N-((S)-2-((1S,3S,5S)-3-Cyano-2-azabicyclo[3.1.0]hexan-2-yl)-1-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)-2-oxoethyl)formamide |
| Related API | Saxagliptin |
| Category | Impurities |
Saxagliptin N-Formyl Impurity product with CAS: NA is also known as (1S,3S,5S)-2-[(2S)-2-Formylamino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo [3.1.0] hexane-3-carbonitrile. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Saxagliptin N-Formyl Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Saxagliptin and its related formulations. Moreover, (1S,3S,5S)-2-[(2S)-2-Formylamino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo [3.1.0] hexane-3-carbonitrile 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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