N-Nitroso-Vildagliptin-d3 amide Impurity CAS CATO-C4X-1100109

Description

The occurrence of N-Nitroso-Vildagliptin-d3 amide Impurity is closely related to deuterium isotope labeling, a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies N-Nitroso-Vildagliptin-d3 amide Impurity (CAS CATO-C4X-1100109), a pharmacopoeial impurity reference standard (molecular formula C17H23D3N4O4, MW 353.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, N-Nitroso-Vildagliptin-d3 amide Impurity (C17H23D3N4O4) contains deuterium isotope labeling, a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.5, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 353.43 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), N-Nitroso-Vildagliptin-d3 amide Impurity meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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