Bendamustine Impurity 10 CAS CATO-C4X-127110

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-127110
Molecular FormulaC20H29Cl2N3O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Impurity 10 CAS CATO-C4X-127110 chemical structure

Description

Bendamustine Impurity 10 (CAS CATO-C4X-127110) is a certified pharmaceutical impurity reference standard with the molecular formula C20H29Cl2N3O2HCl and a molecular weight of 450.83 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Bendamustine Impurity 10 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 450.83 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 10 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 FormulaC20H29Cl2N3O2 HCl
Molecular Weight450.83 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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