Description

Bedaquiline Impurity 14 is a designated impurity standard used in the pharmaceutical development and quality control of the anti-tuberculosis drug Bedaquiline. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Bedaquiline.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bedaquiline active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure that Bedaquiline batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Bedaquiline.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Bedaquiline synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Bedaquiline Impurity 14
CAS No.	654654-93-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bedaquiline Related Compound 14; Bedaquiline EP Impurity 14; Bedaquiline USP Impurity 14; TMC207 Impurity 14; (1R,2S)-1-(6-Bromo-2-methoxy-3-quinolyl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenyl-2-butanol Impurity; SIRTURO Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Bedaquiline Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial 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 at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment and handled under appropriate laboratory conditions to maintain stability.

Specification

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

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