Alogliptin

Alogliptin Impurities

Alogliptin impurities include synthetic intermediates, process-related compounds, degradation products, and potentially genotoxic contaminants that may arise during synthesis, formulation, or storage. As a selective dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes mellitus, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Several impurities have been identified and characterized using LC–MS methods, including reactive bases and electrophilic species that require close monitoring due to genotoxic potential. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Alogliptin EP Impurities

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

Alogliptin Related Compounds

Structurally related compounds and synthetic analogs associated with Alogliptin 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.

Alogliptin Impurity Reference Standards

Alogliptin 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.