Otilonium Bromide Impurity 1 CAS 255062-85-2

Description

Compared with other compounds in its class, the molecular weight of 264.36 g/mol gives Otilonium Bromide Impurity 1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Otilonium Bromide Impurity 1 (CAS 255062-85-2, C16H24O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Otilonium Bromide Impurity 1 (C16H24O3) 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Otilonium Bromide Impurity 1 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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