Ketotifen EP Impurity F (Mixture of Enol and Ketone) CAS 34580-09-1

Description

Compared with other compounds in its class, the molecular weight of 309.43 g/mol gives Ketotifen EP Impurity F (Mixture of Enol and Ketone) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Ketotifen EP Impurity F (Mixture of Enol and Ketone) (CAS 34580-09-1, C19H19NOS) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage, Ketotifen EP Impurity F (Mixture of Enol and Ketone) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 309.43 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Ketotifen EP Impurity F (Mixture of Enol and Ketone) 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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