Edoxaban impurity 129 CAS CATO-C4X-1063129

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1063129
Molecular FormulaC9H14N2O3
Molecular Weight198.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Edoxaban impurity 129 CAS CATO-C4X-1063129 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Edoxaban impurity 129.

Edoxaban impurity 129 (CAS CATO-C4X-1063129) is a certified pharmaceutical impurity reference standard with the molecular formula C9H14N2O3 and a molecular weight of 198.22 g/mol.

Edoxaban impurity 129 (C9H14N2O3) 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 manufactures Edoxaban impurity 129 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 FormulaC9H14N2O3
Molecular Weight198.22 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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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