Bedaquiline Impurity 53 CAS 654653-95-9

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.654653-95-9
Molecular Formula2*C32H31BrN2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bedaquiline Impurity 53 CAS 654653-95-9 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bedaquiline Impurity 53.

Bedaquiline Impurity 53 (CAS 654653-95-9) is a certified pharmaceutical impurity reference standard with the molecular formula C32H31BrN2O2 and a molecular weight of 555.52 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution, Bedaquiline Impurity 53 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 555.52 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).

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.

CATO manufactures Bedaquiline Impurity 53 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

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

Related Bedaquiline Standards

Recommended Standards

Why CATO?