Bisacodyl Impurity 16 CAS CATO-C4X-203716

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bisacodyl Impurity 16.

Bisacodyl Impurity 16 (CAS CATO-C4X-203716) is a certified pharmaceutical impurity reference standard with the molecular formula C23H21NO4 and a molecular weight of 375.42 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Bisacodyl Impurity 16 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 375.42 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Bisacodyl Impurity 16 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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