Description

Vernakalant Impurity 2 ((3S,1'R,2'R)-Isomer) Hcl is a high-purity chemical reference standard, specifically the (3S,1'R,2'R)-stereoisomer of a Vernakalant-related impurity. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the purity and safety of the active pharmaceutical ingredient. It is primarily required by research institutions, quality assurance laboratories, and pharmaceutical companies engaged in the development and production of antiarrhythmic drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific stereoisomeric impurities in Vernakalant active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and analyze Vernakalant and its related substances.
• Quality Control & Assurance: Serves as a system suitability test component and a quantitation standard in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity standards required for stability studies and impurity qualification reports.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of specific stereoisomers and their potential biological activity.

Basic Information

Product Name	Vernakalant Impurity 2 ((3S,1'R,2'R)-Isomer) Hcl
CAS No.	795281-99-1
Molecular Formula	C20H28N2O3 • HCl
Molecular Weight	380.91 g/mol (Free base: 344.45 g/mol)
Synonyms	(3S,1'R,2'R)-Vernakalant Impurity 2 Hydrochloride; 1-(3S)-1-Pyrrolidinyl-2-[(1R,2R)-2-(4-methoxyphenyl)cyclopropyl]ethanone Hydrochloride; Vernakalant Related Compound 2 ((3S,1'R,2'R)-Isomer) HCl; RSD1235 Impurity 2 (S,R,R Isomer) HCl; (3S,1'R,2'R)-RSD 1235 Impurity Hydrochloride; Vernakalant Stereoisomer Impurity HCl; RSD-1235 Impurity C HCl (specific isomer)
EINECS	Contact for details

Quality Control

Our Vernakalant Impurity 2 ((3S,1'R,2'R)-Isomer) Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for stereochemical purity, NMR for structural confirmation, and mass spectrometry for identity verification. We provide a comprehensive Certificate of Analysis (COA) detailing purity, impurity profile, and analytical data, supporting compliance with ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (for specified (3S,1'R,2'R) isomer)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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