Saxagliptin Carboxylic Acid Impurity

Saxagliptin Carboxylic Acid Impurity product with CAS: 1802786-89-5 is also known as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo [3.1.0] hexane-3-carboxylic acid. 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 Carboxylic Acid 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-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo [3.1.0] hexane-3-carboxylic acid is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.