Paliperidone Impurity 9 CAS 84163-16-6

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Paliperidone Impurity 9.

CATO supplies Paliperidone Impurity 9 (CAS 84163-16-6), a pharmacopoeial impurity reference standard (molecular formula C12H13FN2OHCl, MW 256.70 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Paliperidone Impurity 9 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 256.70 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), Paliperidone Impurity 9 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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