Description

Saxagliptin N-Acetate Impurity product with CAS: NA is also known as (1S,3S,5S)-2-[(2S)-2-Acetylamino-2-(3-hydroxy-1-adamantanyl)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-Acetate 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-Acetylamino-2-(3-hydroxy-1-adamantanyl)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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