Bedaquiline Impurity N1 CAS 39648-67-4

Description

Compared with other compounds in its class, the molecular weight of 348.29 g/mol gives Bedaquiline Impurity N1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Bedaquiline Impurity N1 (CAS 39648-67-4, C20H13O4P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Bedaquiline Impurity N1 (C20H13O4P) contains a flavonoid core, a phosphate ester group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 14.5, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 348.29 g/mol, it falls into the moderately-high-molecular-weight range. 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), Bedaquiline Impurity N1 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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