Description

Vernakalant Impurity 7 ((3R,1'R,2'S)-Isomer) is a specific stereoisomeric impurity associated with the antiarrhythmic drug Vernakalant. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers and contract research organizations (CROs) to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Vernakalant active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating specific, stability-indicating HPLC or UPLC methods to quantify and control this isomer in drug substances.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data for drug submissions.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation and levels of this specific impurity over time.
• Process Chemistry Research: Used by synthetic chemists to understand and optimize the manufacturing process to minimize the formation of this stereoisomeric impurity.
• Pharmacopoeial Standards: Can serve as a potential candidate for inclusion in pharmacopoeial monographs (e.g., USP, EP) for Vernakalant.

Basic Information

Product Name	Vernakalant Impurity 7 ((3R,1'R,2'S)-Isomer)
CAS No.	795282-29-0
Molecular Formula	C20H30N2O3
Molecular Weight	346.47 g/mol
Synonyms	(3R,1'R,2'S)-Vernakalant Impurity 7; (1R,2S)-2-[(3R)-1-(3,4-Dimethoxyphenethyl)pyrrolidin-3-yl]-1-cyclohexyl-2-hydroxyethan-1-one; Vernakalant Related Compound 7; (3R,1'R,2'S)-Isomer of Vernakalant Impurity; RSV1307; UNII-Contact for details; IUPAC: (1R,2S)-2-[(3R)-1-[2-(3,4-dimethoxyphenyl)ethyl]pyrrolidin-3-yl]-1-cyclohexyl-2-hydroxyethan-1-one
EINECS	Contact for details

Quality Control

Every batch of our Vernakalant Impurity 7 is produced and analyzed under strict quality systems. We provide comprehensive analytical data, including HPLC purity, chiral purity confirmation, and structural elucidation data (1H NMR, MS). A detailed Certificate of Analysis (COA) is supplied with each shipment, containing batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical R&D and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (for specified isomer)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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