Edoxaban Impurity 33 CAS 349125-14-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.349125-14-0
Molecular FormulaC12H8Cl2N4O2
Molecular Weight311.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Edoxaban Impurity 33 CAS 349125-14-0 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 311.12 g/mol gives Edoxaban Impurity 33 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Edoxaban Impurity 33 (CAS 349125-14-0) is a certified pharmaceutical impurity reference standard with the molecular formula C12H8Cl2N4O2 and a molecular weight of 311.12 g/mol.

The molecular framework of Edoxaban Impurity 33 (C12H8Cl2N4O2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

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 FormulaC12H8Cl2N4O2
Molecular Weight311.12 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentCl-containing
Nitrogen Atoms4

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