Tenofovir Impurity 59 CAS 116384-56-6

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Tenofovir Impurity 59.

CATO supplies Tenofovir Impurity 59 (CAS 116384-56-6), a pharmacopoeial impurity reference standard (molecular formula C7H16ClO4P, MW 230.63 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C7H16ClO4P, Tenofovir Impurity 59 contains a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 230.63 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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