Midecamycin Impurity 10 CAS CATO-C4X-312210

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Midecamycin Impurity 10.

CATO supplies Midecamycin Impurity 10 (CAS CATO-C4X-312210), a pharmacopoeial impurity reference standard (molecular formula C32H55NO9C2H6O2C2H6OC2H4OCH4OCH2O, MW 812.05 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, Midecamycin Impurity 10 is typically white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 812.05 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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