Butylphthalide Impurity 46 CAS 26311-42-2

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Butylphthalide Impurity 46.

As a process- or degradation-related impurity, Butylphthalide Impurity 46 (CAS 26311-42-2, C12H16O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Butylphthalide Impurity 46 (C12H16O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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 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), Butylphthalide Impurity 46 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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