Dabigatran Impurity 147 CAS 1370605-46-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1370605-46-1
Molecular FormulaC10H14N2O3
Molecular Weight210.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity 147 CAS 1370605-46-1 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 147 (CAS 1370605-46-1), a pharmacopoeial impurity reference standard (molecular formula C10H14N2O3, MW 210.23 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Dabigatran Impurity 147 (C10H14N2O3) is characterized by an amino-acid-derived structure, 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.

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

Molecular FormulaC10H14N2O3
Molecular Weight210.23 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Nitrogen Atoms2

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