Bendamustine Impurity 38 CAS CATO-C4X-127138

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-127138
Molecular FormulaC18H27N3O5
Molecular Weight365.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Impurity 38 CAS CATO-C4X-127138 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.

Bendamustine Impurity 38 (CAS CATO-C4X-127138) is a certified pharmaceutical impurity reference standard with the molecular formula C18H27N3O5 and a molecular weight of 365.42 g/mol.

Based on its molecular formula C18H27N3O5, Bendamustine Impurity 38 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 365.42 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

As a certified reference material (CRM), Bendamustine Impurity 38 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 FormulaC18H27N3O5
Molecular Weight365.42 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity95%
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
Nitrogen Atoms3

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