Description

Vernakalant Impurity 3 ((3S,1'R,2'S)-Isomer) is a specific stereoisomeric impurity of the antiarrhythmic agent Vernakalant. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring drug purity, safety, and efficacy. The precise characterization and control of this impurity are essential for meeting stringent pharmacopeial standards and regulatory compliance in the production of Vernakalant.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified reference material (CRM) for the qualitative and quantitative analysis of Vernakalant drug substance and products.
• Analytical Method Development: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to detect and quantify process-related impurities.
• Quality Control & Assurance: Employed in routine QC testing of active pharmaceutical ingredients (APIs) to monitor and control impurity profiles against ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity identification, qualification, and control strategies.
• Stability Studies: Used to track the formation and levels of this specific isomer during forced degradation and long-term stability testing of Vernakalant formulations.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this stereoisomeric impurity.

Basic Information

Product Name	Vernakalant Impurity 3 ((3S,1'R,2'S)-Isomer)
CAS No.	795282-30-3
Molecular Formula	C20H28N2O3
Molecular Weight	344.45 g/mol
Synonyms	(3S,1'R,2'S)-Vernakalant Impurity 3; (3S,1'R,2'S)-Isomer of Vernakalant Impurity; (1R,2S)-2-[(3S)-3-Pyrrolidinyl]-1-(2,3,4,5,6,7-hexahydro-1H-azepin-1-yl)-1-cyclohexanol; RSV 795282-30-3; Vernakalant Related Compound C (stereoisomer); Vernakalant Stereoisomer Impurity; RSD 1305 Impurity
EINECS	Contact for details

Quality Control

Every batch of Vernakalant Impurity 3 ((3S,1'R,2'S)-Isomer) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, analytical methods, and traceability. Our quality commitment aligns with cGMP and ICH guidelines to support your regulatory needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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