Description

Bedaquiline Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anti-tuberculosis drug Bedaquiline. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Bedaquiline active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation and level of this impurity during forced degradation and long-term stability studies of Bedaquiline formulations.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity during Bedaquiline manufacturing.
• Pharmacopoeial Testing: Serves as a reference material for testing against monographs in pharmacopoeias such as USP or EP.

Basic Information

Product Name	Bedaquiline Impurity 13
CAS No.	2122862-01-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6-Bromo-2-methoxyquinolin-3-yl)(4-(dimethylamino)naphthalen-1-yl)methanone; Bedaquiline Related Compound 13; Bedaquiline Impurity K; TMC207 Impurity 13; Sirturo Impurity 13; Bedaquiline Process Impurity; Bedaquiline Degradant
EINECS	Contact for details

Quality Control

Every batch of Bedaquiline Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH, and relevant pharmacopoeial standards for pharmaceutical impurities.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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