Difenidol Impurity 8 HCl CAS 17874-62-3

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Difenidol Impurity 8 HCl.

As a process- or degradation-related impurity, Difenidol Impurity 8 HCl (CAS 17874-62-3, C8H17NHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C8H17NHCl, Difenidol Impurity 8 HCl contains chlorine substitution; these features give the compound characteristic molecular-ion distribution patterns in mass spectrometry. The molecular weight of 163.69 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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