Description

Vernakalant Impurity 4 ((3S,1'S,2'R)-Isomer) is a specific stereoisomeric impurity of the antiarrhythmic agent Vernakalant. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Vernakalant drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Vernakalant active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific stereoisomeric impurity.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies of Vernakalant formulations.

Basic Information

Product Name	Vernakalant Impurity 4 ((3S,1'S,2'R)-Isomer)
CAS No.	795282-28-9
Molecular Formula	C20H28N2O3
Molecular Weight	344.45 g/mol
Synonyms	(3S,1'S,2'R)-Vernakalant Impurity 4; (3S,1'S,2'R)-Isomer of Vernakalant Impurity; (2R,3S)-1-[(1S)-1-(3,4-Dimethoxyphenethyl)piperidin-3-yl]-3-phenyl-3-(pyrrolidin-1-yl)propan-2-ol; RSV 740; Vernakalant Related Compound 4; Vernakalant Stereoisomer Impurity; Atrial Fibrillation Drug Impurity
EINECS	Contact for details

Quality Control

Our Vernakalant Impurity 4 is manufactured under strict quality systems to ensure the highest standards of identity, purity, and stability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, LC-MS, NMR, and chiral analysis. The product is suitable for use in GMP/GLP-compliant environments and meets the stringent requirements outlined in ICH Q3A (R2) and ICH Q6A guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Assay (on dried basis)	97.0% - 103.0%

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