Dabigatran Impurity 46 CAS 1642853-68-6

Description

Compared with other compounds in its class, the molecular weight of 658.71 g/mol gives Dabigatran Impurity 46 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Dabigatran Impurity 46 (CAS 1642853-68-6) is a certified pharmaceutical impurity reference standard with the molecular formula C36H34N8O5 and a molecular weight of 658.71 g/mol.

The molecular framework of Dabigatran Impurity 46 (C36H34N8O5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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