Description

n-Desmethyl Bedaquiline is a key pharmaceutical intermediate and metabolite of the anti-tuberculosis drug Bedaquiline. This compound is of critical importance for research and development in the pharmaceutical industry, particularly for studies related to drug metabolism, pharmacokinetics, and the synthesis of novel therapeutic agents. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) who require high-purity reference standards and building blocks.

Application

• Primary reference standard for the analytical quantification of Bedaquiline and its metabolites in biological matrices.
• Critical intermediate in the research-scale synthesis and process development of Bedaquiline and its structural analogs.
• Essential material for conducting in vitro and in vivo metabolism and pharmacokinetic (DMPK) studies.
• Used in the development and validation of analytical methods, such as HPLC and LC-MS/MS, for impurity profiling.
• Serves as a starting material for the synthesis of deuterated or other isotopically labeled versions for use as internal standards.
• Valuable compound for investigative toxicology and safety assessment studies of Bedaquiline-related substances.

Basic Information

Product Name	n-Desmethyl Bedaquiline
CAS No.	654654-76-9
Molecular Formula	C32H31BrN2O2
Molecular Weight	555.51 g/mol
Synonyms	(1R,2S)-1-(6-Bromo-2-methoxy-3-quinolinyl)-4-(dimethylamino)-2-(1-naphthalenyl)-1-phenyl-2-butanol; TMC207 Metabolite M2; R207910 Metabolite; Bedaquiline N-Desmethyl Metabolite; (1R,2S)-1-(6-Bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(naphthalen-1-yl)-1-phenylbutan-2-ol; SIRTURO Metabolite
EINECS	Contact for details

Quality Control

Our n-Desmethyl Bedaquiline is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with cGMP guidelines where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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