Mitiglinide Calcium Impurity 13 CAS CATO-C4X-116113

Description

Compared with other compounds in its class, the molecular weight of 343.46 g/mol gives Mitiglinide Calcium Impurity 13 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Mitiglinide Calcium Impurity 13 (CAS CATO-C4X-116113), a pharmacopoeial impurity reference standard (molecular formula C21H29NO3, MW 343.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Mitiglinide Calcium Impurity 13 (C21H29NO3) contains a steroid core, 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Mitiglinide Calcium Impurity 13 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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