Description

Bedaquiline (1S,2S) Isomer Impurity 3 is a defined stereoisomeric impurity associated with the antituberculosis drug Bedaquiline. This compound is critical for analytical method development, quality control, and regulatory compliance in pharmaceutical manufacturing. It is primarily used by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the synthesis and purification of Bedaquiline active pharmaceutical ingredient (API).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of the (1S,2S) isomer in Bedaquiline drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and stability-indicating assays.
• Quality Control & Batch Release Testing: Essential for establishing specification limits and ensuring the purity and safety of Bedaquiline API according to ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to characterize and control impurities in the drug substance.
• Stability Studies: Used to monitor the formation of this specific isomer under various stress conditions (heat, light, humidity) to determine drug product shelf-life.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway to minimize the formation of this isomeric impurity.

Basic Information

Product Name	Bedaquiline (1S,2S) Isomer Impurity 3
CAS No.	1972612-60-4
Molecular Formula	C32H31BrN2O2
Molecular Weight	555.51 g/mol
Synonyms	(1S,2S)-Bedaquiline Impurity 3; (1S,2S)-TMC207 Impurity 3; (1S,2S)-Isomer of Bedaquiline; (1S,2S)-Bedaquiline Related Compound C; (1S,2S)-Sirturo Impurity; (1R,2R)-1-(6-Bromo-2-methoxy-3-quinolyl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenyl-2-butanol (enantiomer); Bedaquiline Diastereomer Impurity; Bedaquiline EP Impurity C (S,S-isomer)
EINECS	Contact for details

Quality Control

Every batch of Bedaquiline (1S,2S) Isomer Impurity 3 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, LC-MS, and NMR. We support compliance with ICH, USP, and EP guidelines for impurity characterization.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under inert atmosphere for long-term stability. For short-term use, the material may be stored at 2-8°C. The container should be allowed to reach room temperature before opening to prevent condensation. Store in a dry, well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C Class 1 & 2 limits
Water Content (KF)	≤ 0.5% w/w

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