Mirogabalin Impurity 64 CAS 1644251-71-7

Description

The occurrence of Mirogabalin Impurity 64 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Mirogabalin Impurity 64 (CAS 1644251-71-7), a pharmacopoeial impurity reference standard (molecular formula C12H19NO2, MW 209.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Mirogabalin Impurity 64 (C12H19NO2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Mirogabalin Impurity 64 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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