Bedaquiline Impurity 13 (Mixture of Diastereomers) CAS 654653-92-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.654653-92-6
Molecular Formula2*C32H31BrN2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bedaquiline Impurity 13 (Mixture of Diastereomers) CAS 654653-92-6 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 555.52 g/mol gives Bedaquiline Impurity 13 (Mixture of Diastereomers) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Bedaquiline Impurity 13 (Mixture of Diastereomers) (CAS 654653-92-6, C32H31BrN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Bedaquiline Impurity 13 (Mixture of Diastereomers) (C32H31BrN2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Bedaquiline Impurity 13 (Mixture of Diastereomers) 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 Formula2*C32H31BrN2O2
Molecular Weight555.52 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1985
Halogen ContentBr-containing
Nitrogen Atoms2

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