Doxofylline Impurity 6 CAS 1429636-72-5

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Doxofylline Impurity 6.

CATO supplies Doxofylline Impurity 6 (CAS 1429636-72-5), a pharmacopoeial impurity reference standard (molecular formula C11H16N4O4, MW 268.27 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Doxofylline Impurity 6 (C11H16N4O4) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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