Dabigatran Impurity 28 CAS 1456889-80-7

Description

Compared with other compounds in its class, the molecular weight of 366.41 g/mol gives Dabigatran Impurity 28 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dabigatran Impurity 28 (CAS 1456889-80-7), a pharmacopoeial impurity reference standard (molecular formula C20H22N4O3, MW 366.41 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Dabigatran Impurity 28 (C20H22N4O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 366.41 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 28 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

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
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