Roflumilast Impurity 53 CAS 2204417-23-0

Description

The occurrence of Roflumilast Impurity 53 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Roflumilast Impurity 53 (CAS 2204417-23-0, C17H14Cl2F2N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C17H14Cl2F2N2O3, Roflumilast Impurity 53 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 403.21 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

CATO manufactures Roflumilast Impurity 53 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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