Description

Bedaquiline Fumarate CAS NO 845533-86-0 is a high-purity pharmaceutical active ingredient, specifically the fumarate salt of the diarylquinoline antimycobacterial agent. This compound is of critical importance as a key component in the formulation of second-line treatments for multidrug-resistant tuberculosis (MDR-TB). It is primarily required by global pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of life-saving anti-tuberculosis therapeutics.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of finished dosage forms targeting multidrug-resistant tuberculosis (MDR-TB).
• Reference Standard in analytical laboratories for quality control and method validation of Bedaquiline-containing drug products.
• Research & Development material for preclinical and clinical studies exploring new TB treatment regimens and combination therapies.
• Process Development for optimizing synthesis, purification, and formulation processes in pharmaceutical development.
• Regulatory Submissions, providing the necessary quality and characterization data for drug master files (DMFs) and marketing authorization applications.

Basic Information

Product Name	Bedaquiline Fumarate
CAS No.	845533-86-0
Molecular Formula	C40H44Br2N2O6
Molecular Weight	784.60 g/mol
Synonyms	(1R,2S)-1-(6-Bromo-2-methoxy-3-quinolinyl)-4-(dimethylamino)-2-(1-naphthalenyl)-1-phenyl-2-butanol fumarate; TMC207 fumarate; R207910 fumarate; Sirturo (brand name API); Bedaquiline (base) fumarate salt; (1R,2S)-1-(6-Bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(naphthalen-1-yl)-1-phenylbutan-2-ol (E)-but-2-enedioate
EINECS	Contact for details

Quality Control

Our Bedaquiline Fumarate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH Q7 guidelines for active pharmaceutical ingredients. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with agreed-upon specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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