Dabigatran Impurity 12 CAS CATO-C4X-108912

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108912
Molecular FormulaC26H25N7O5
Molecular Weight515.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity 12 CAS CATO-C4X-108912 chemical structure

Description

CATO manufactures Dabigatran Impurity 12 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.

Dabigatran Impurity 12 (CAS CATO-C4X-108912) is a certified pharmaceutical impurity reference standard with the molecular formula C26H25N7O5 and a molecular weight of 515.52 g/mol.

The molecular framework of Dabigatran Impurity 12 (C26H25N7O5) is characterized by a steroid core, 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. 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.

Physical & Chemical Properties

Molecular FormulaC26H25N7O5
Molecular Weight515.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms7

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