Bendamustine Impurity 35 CAS CATO-C4X-127135

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-127135
Molecular FormulaC16H22ClN3O2
Molecular Weight323.82 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Impurity 35 CAS CATO-C4X-127135 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Bendamustine Impurity 35 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 323.82 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

CATO supplies Bendamustine Impurity 35 (CAS CATO-C4X-127135), a pharmacopoeial impurity reference standard (molecular formula C16H22ClN3O2, MW 323.82 g/mol) used for the identification and quantification of trace impurities in APIs.

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), Bendamustine Impurity 35 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 FormulaC16H22ClN3O2
Molecular Weight323.82 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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