This impurity is related to Saxagliptin Impurity 21 is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Asenapine.
Saxagliptin Impurity 21 is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:(S)-2,3-Dihydro-1H-pyrrole-1,2-dicarboxylic acid 1-(1,1-dimethylethyl) 2-Ethyl Ester; (S)-2,3-Dihydropyrrole-1,2-dicarboxylic Acid 1-tert-Butyl Ester 2-Ethyl Ester; 1-(tert-butyl) 2-ethyl (S)-2,3-dihydro-1H-pyrrole-1,2-dicarboxylateCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Saxagliptin Molecular Formula: C12H19NO4
Molecular Weight: 241.3
Storage: Store in a cool, dry place.