Saxagliptin

Saxagliptin Impurities

Saxagliptin impurities include synthetic intermediates, process-related compounds, degradation products, and potential nitrosamine contaminants that may arise during synthesis, formulation, or storage. As a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Saxagliptin EP Impurities

Pharmacopeial and non-pharmacopeial Saxagliptin impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. EP traceable impurity mixtures are supplied with validated analytical data including purity, structural confirmation, and spectral characterization. These standards support analytical method development, impurity profiling, and stability testing.

Saxagliptin Related Compounds

Structurally related compounds and synthetic analogs associated with Saxagliptin are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Saxagliptin Impurity Reference Standards

Saxagliptin impurity reference standards are provided with validated analytical data including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.