Dabigatran Impurity 42 CAS 42288-26-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.42288-26-6
Molecular FormulaC9H8N2O2
Molecular Weight176.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dabigatran Impurity 42 CAS 42288-26-6 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 176.17 g/mol gives Dabigatran Impurity 42 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Dabigatran Impurity 42 (CAS 42288-26-6, C9H8N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Dabigatran Impurity 42 (C9H8N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Dabigatran Impurity 42 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC9H8N2O2
Molecular Weight176.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1969
Nitrogen Atoms2

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