Dabigatran Impurity 13 CAS 212321-78-3

Description

Compared with other compounds in its class, the molecular weight of 599.68 g/mol gives Dabigatran Impurity 13 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Dabigatran Impurity 13 (CAS 212321-78-3) is a certified pharmaceutical impurity reference standard with the molecular formula C32H37N7O5 and a molecular weight of 599.68 g/mol.

Based on its molecular formula C32H37N7O5, Dabigatran Impurity 13 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 599.68 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 Dabigatran Impurity 13 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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