Indometacin EP Impurity J CAS 402849-25-6

Description

Compared with other compounds in its class, the molecular weight of 616.49 g/mol gives Indometacin EP Impurity J distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Indometacin EP Impurity J (CAS 402849-25-6), a pharmacopoeial impurity reference standard (molecular formula C33H27Cl2N3O5, MW 616.49 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Indometacin EP Impurity J (C33H27Cl2N3O5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Indometacin EP Impurity J 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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