Bendamustine Ether Impurity (HCl) CAS 2173004-95-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2173004-95-8
Molecular FormulaC16H21N3O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bendamustine Ether Impurity (HCl) CAS 2173004-95-8 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Bendamustine Ether Impurity (HCl) is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 339.82 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Bendamustine Ether Impurity (HCl) (CAS 2173004-95-8) is a certified pharmaceutical impurity reference standard with the molecular formula C16H21N3O3HCl and a molecular weight of 339.82 g/mol.

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 Ether Impurity (HCl) 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 FormulaC16H21N3O3 HCl
Molecular Weight339.82 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
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
CAS Registry Year (est.)1998
Halogen ContentCl-containing
Nitrogen Atoms3

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