Dabigatran Impurity 2 CAS 2225986-95-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2225986-95-6
Molecular FormulaC34H41N7O5
Molecular Weight627.73 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity 2 CAS 2225986-95-6 chemical structure

Description

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 supplies Dabigatran Impurity 2 (CAS 2225986-95-6), a pharmacopoeial impurity reference standard (molecular formula C34H41N7O5, MW 627.73 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Dabigatran Impurity 2 (C34H41N7O5) 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).

CATO manufactures Dabigatran Impurity 2 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

Molecular FormulaC34H41N7O5
Molecular Weight627.73 g/mol
Purity>95%
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
CAS Registry Year (est.)1998
Nitrogen Atoms7

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