Description

Vernakalant Impurity 8 ((3R,1'S,2'R)-Isomer) is a specific stereoisomeric impurity associated with the antiarrhythmic drug Vernakalant. This compound matters as a critical reference standard for pharmaceutical research and development, enabling precise identification, quantification, and control of process-related impurities. It is essential for analytical chemists and quality control laboratories in the pharmaceutical industry to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific isomer in Vernakalant Active Pharmaceutical Ingredient (API) and finished drug products.
• Quality Control & Assurance: Used in-house by API manufacturers to monitor and control synthesis processes to meet ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Monitoring the formation or increase of this impurity during drug product stability testing.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during drug development.

Basic Information

Product Name	Vernakalant Impurity 8 ((3R,1'S,2'R)-Isomer)
CAS No.	795282-27-8
Molecular Formula	C20H28N2O3
Molecular Weight	344.45 g/mol
Synonyms	(3R,1'S,2'R)-Vernakalant Impurity 8; (3R,1'S,2'R)-Isomer of Vernakalant Impurity 8; (1R,2S)-2-[(3R)-1-(3,4-Dimethoxyphenethyl)pyrrolidin-3-yloxy]cyclohexanamine; Vernakalant Related Compound 8 ((3R,1'S,2'R)-Isomer); RSD 1235A Impurity; Vernakalant Stereoisomer Impurity; (3R,1'S,2'R)-2-[(3R)-1-[2-(3,4-Dimethoxyphenyl)ethyl]pyrrolidin-3-yl]oxycyclohexanamine
EINECS	Contact for details

Quality Control

Our Vernakalant Impurity 8 ((3R,1'S,2'R)-Isomer) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to confirm identity, stereochemical purity, and chemical purity. We provide comprehensive Certificates of Analysis (COA) with batch-specific data to support your regulatory and research needs, ensuring compliance with ICH 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. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Chemical Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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