Lercanidipine Impurity 76 CAS CATO-C4X-136476

Description

The occurrence of Lercanidipine Impurity 76 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Lercanidipine Impurity 76 (CAS CATO-C4X-136476), a pharmacopoeial impurity reference standard (molecular formula C35H36N4O7, MW 624.68 g/mol) used for the identification and quantification of trace impurities in APIs.

Lercanidipine Impurity 76 (C35H36N4O7) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Lercanidipine Impurity 76 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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