Bedaquiline

Bedaquiline Impurities

Bedaquiline impurities include synthetic intermediates, process-related compounds, degradation products, and residual solvents that may arise during synthesis, formulation, or storage. As a diarylquinoline antimycobacterial agent used in the treatment of multidrug-resistant tuberculosis (MDR-TB), impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Known degradation pathways include oxidative cleavage and hydrolysis of the quinoline and tertiary amine functionalities under acidic, basic, or photolytic conditions. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Bedaquiline EP Impurities

Pharmacopeial and non-pharmacopeial Bedaquiline impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials are supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Bedaquiline Related Compounds

Structurally related compounds and synthetic analogs associated with Bedaquiline are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Bedaquiline Impurity Reference Standards

Bedaquiline impurity reference standards are provided with validated analytical data including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.