Dabigatran Impurity 65 CAS 7523-15-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.7523-15-1
Molecular FormulaC13H26O3
Molecular Weight230.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity 65 CAS 7523-15-1 chemical structure

Description

CATO manufactures Dabigatran Impurity 65 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.

CATO supplies Dabigatran Impurity 65 (CAS 7523-15-1), a pharmacopoeial impurity reference standard (molecular formula C13H26O3, MW 230.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C13H26O3, Dabigatran Impurity 65 contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 230.34 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC13H26O3
Molecular Weight230.34 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1959

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