Dabigatran Impurity 94 CAS 58906-64-2

Description

Compared with other compounds in its class, the molecular weight of 164.63 g/mol gives Dabigatran Impurity 94 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dabigatran Impurity 94 (CAS 58906-64-2), a pharmacopoeial impurity reference standard (molecular formula C7H13ClO2, MW 164.63 g/mol) used for the identification and quantification of trace impurities in APIs.

Dabigatran Impurity 94 (C7H13ClO2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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