Afatinib Impurity 91 CAS 2512206-82-3

Description

Compared with other compounds in its class, the molecular weight of 353.14 g/mol gives Afatinib Impurity 91 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Afatinib Impurity 91 (CAS 2512206-82-3, C14H7Cl2FN4O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Afatinib Impurity 91 (C14H7Cl2FN4O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Afatinib Impurity 91 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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