Ruxolitinib Impurity 117 CAS CATO-C4X-2058117

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ruxolitinib Impurity 117.

As a process- or degradation-related impurity, Ruxolitinib Impurity 117 (CAS CATO-C4X-2058117, C17H18N6O) 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, Ruxolitinib Impurity 117 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 322.36 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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