Bromhexine Impurity 31 CAS CATO-C4X-106031

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106031
Molecular FormulaC20H30Br2N2O5
Molecular Weight538.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bromhexine Impurity 31 CAS CATO-C4X-106031 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.

Bromhexine Impurity 31 (CAS CATO-C4X-106031) is a certified pharmaceutical impurity reference standard with the molecular formula C20H30Br2N2O5 and a molecular weight of 538.27 g/mol.

Bromhexine Impurity 31 (C20H30Br2N2O5) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

As a certified reference material (CRM), Bromhexine Impurity 31 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 FormulaC20H30Br2N2O5
Molecular Weight538.27 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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 ContentBr-containing
Nitrogen Atoms2

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