Description

Bedaquiline Impurity 5 is a designated impurity standard of the anti-tuberculosis drug Bedaquiline, identified by CAS NO 916801-19-9. This high-purity reference material is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality control of Bedaquiline formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Bedaquiline API and finished drug products.
• Method Development & Validation: Critical for developing, optimizing, and validating analytical methods (e.g., HPLC, UPLC) to separate and quantify impurities.
• Stability Studies: Used to monitor the formation and level of this specific impurity during forced degradation and long-term stability studies of Bedaquiline.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Process Chemistry R&D: Aids in understanding and controlling the synthetic pathway of Bedaquiline to minimize the formation of this impurity.
• Pharmacopoeial Testing: Serves as a system suitability and identification standard for testing per pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Bedaquiline Impurity 5
CAS No.	916801-19-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R)-1-[(6-Bromo-2-methoxy-3-quinolinyl)methyl]-6-methoxy-α-[(1R)-1-naphthalenyl]-3-quinolineethanol; Bedaquiline Related Compound 5; TMC207 Impurity 5; Sirturo Impurity 5; (R)-1-((6-Bromo-2-methoxyquinolin-3-yl)methyl)-6-methoxy-α-(R)-naphthalen-1-ylquinoline-3-ethanol; Bedaquiline EP Impurity B; Bedaquiline USP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Bedaquiline Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.