Description

Bedaquiline (Mixture Of Diastereomers) CAS NO 654655-80-8 is a critical pharmaceutical active ingredient belonging to the diarylquinoline class, specifically developed as an antituberculosis agent. It is a cornerstone in the treatment of multidrug-resistant tuberculosis (MDR-TB), offering a novel mechanism of action that targets bacterial ATP synthase. This product is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the development and production of life-saving anti-TB therapeutics.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of anti-tuberculosis drugs.
• Reference Standard in analytical laboratories for quality control and method development.
• Research & Development of new therapeutic regimens and combination therapies for drug-resistant TB.
• Process Development for scale-up and optimization of API synthesis in pharmaceutical manufacturing.
• Regulatory Submissions, supporting the filing of Drug Master Files (DMFs) and new drug applications.

Basic Information

Product Name	Bedaquiline (Mixture Of Diastereomers)
CAS No.	654655-80-8
Molecular Formula	C32H31BrN2O2
Molecular Weight	555.51 g/mol
Synonyms	TMC207; R207910; (1R,2S)-1-(6-Bromo-2-methoxy-3-quinolyl)-4-dimethylamino-2-(1-naphthyl)-1-phenylbutan-2-ol; Bedaquiline Fumarate precursor; Sirturo (brand name); Diaryquinoline TMC207; Bedaquiline base
EINECS	Contact for details

Quality Control

Our Bedaquiline (Mixture Of Diastereomers) is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical intermediates and APIs. Certificates of Analysis (COA) with detailed chromatographic data (HPLC) for assay and related substances are provided to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.