Loxapine Impurity 1 (Dimer Impurity, Mixture of Diastereomers) CAS 3454-96-4

Description

As a process- or degradation-related impurity, Loxapine Impurity 1 (Dimer Impurity, Mixture of Diastereomers) (CAS 3454-96-4, C18H18ClN3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Loxapine Impurity 1 (Dimer Impurity, Mixture of Diastereomers) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 327.81 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Loxapine Impurity 1 (Dimer Impurity, Mixture of Diastereomers) 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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