Amiodarone Impurity 12 CAS 4265-27-4

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Amiodarone Impurity 12.

As a process- or degradation-related impurity, Amiodarone Impurity 12 (CAS 4265-27-4, C12H14O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Amiodarone Impurity 12 (C12H14O) contains a hydroxyl group, an ether linkage, an aromatic ring system. Its high carbon-to-hydrogen ratio confers good lipid solubility; 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), Amiodarone Impurity 12 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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