Ambroxol Impurity 95 CAS CATO-C4X-108595

Description

The occurrence of Ambroxol Impurity 95 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Ambroxol Impurity 95 (CAS CATO-C4X-108595) is a certified pharmaceutical impurity reference standard with the molecular formula C19H26Br2N2O6 and a molecular weight of 538.23 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution, Ambroxol Impurity 95 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 538.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Ambroxol Impurity 95 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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