Dexmedetomidine Impurity 77 CAS CATO-C4X-123077

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dexmedetomidine Impurity 77.

CATO supplies Dexmedetomidine Impurity 77 (CAS CATO-C4X-123077), a pharmacopoeial impurity reference standard (molecular formula C13H15N3OHCl, MW 265.74 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, chlorine substitution, Dexmedetomidine Impurity 77 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 265.74 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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