Bedaquiline Related Compounds & Impurities

Bedaquiline is a diarylquinoline antimycobacterial that selectively inhibits ATP synthase in M. tuberculosis, essential for treating multidrug-resistant tuberculosis.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Bedaquiline reference standards, pharmacopeial and non-pharmacopeial Bedaquiline impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Bedaquiline-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Bedaquiline
Bedaquiline Fumarate
N Monodesmethyl Bedaquiline
N-Didesmethyl Bedaquiline
N-Didesmethyl Bedaquiline
2-(3-((1R,2S)-4-(dimethylamino)-2-hydroxy-2-(naphthalen-1-yl)-1-phenylbutyl)-2-methoxyquinolin-6-yl)fumaric acid
(1S,2R)-1-(6-Bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(naphthalen-1-yl)-1-phenylbutan-2-ol
Bedaquiline Des-Bromo Impurity
Bedaquiline Impurity 6 Hydrochloride
Bedaquiline Impurity 5
N-Nitroso-N-Desmethyl Bedaquiline
Bedaquiline Desbromo Diastereomer-B
Racemic Bedaquiline Diastereomer Impurity
Rac-Bedaquiline
Bedaquiline N-Oxide Impurity
Desmethoxy Bedaquiline
Bedaquiline Impurity 10
O-Desmethyl Bedaquiline
Bedaquiline Impurity Mixture (R,S) and (S,R)
Bedaquiline Des-Bromo Impurity 1
Bedaquiline Impurity 8
Bedaquiline Impurity 13
Bedaquiline Impurity 14
Bedaquiline Impurity 17
Bedaquiline Des-Bromo Diastereomer Impurity 2 Hydrobromide
Bedaquiline Des-Bromo Diastereomer Impurity 1
Bedaquiline 2-Naphthyl Diastereomer Impurity 1
Bedaquiline 2-Naphthyl Diastereomer Impurity 2
Bedaquiline Impurity 3 Hydrochloride
Bedaquiline Impurity 2
Bedaquiline Impurity 4
Bedaquiline impurity 7
Bedaquiline Impurity 1
Bedaquiline N-Oxide Impurity 1
Bedaquiline Impurity 9
Rac-bedaquiline hydrochloride
Bedaquiline Impurity 11
Rac-2-Naphthyl Bedaquiline
Bedaquiline Impurity 16
Bedaquiline Impurity 15
Bedaquiline impurity 19

Isotope Labelled Compounds

Bedaquiline-d6
Rac-N-Desmethyl bedaquiline D6