Dabigatran Impurity 48 CAS 1304574-20-6

Description

The occurrence of Dabigatran Impurity 48 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Dabigatran Impurity 48 (CAS 1304574-20-6) is a certified pharmaceutical impurity reference standard with the molecular formula C35H43N7O5 and a molecular weight of 641.76 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Dabigatran Impurity 48 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 641.76 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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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