Description

Vernakalant Impurity 1 ((3S,1'S,2'S)-Isomer) Hcl is a specific stereoisomeric impurity of the antiarrhythmic agent Vernakalant. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this impurity during drug substance synthesis and formulation. It is an essential material for analytical method development, validation, and regulatory compliance in the pharmaceutical industry, ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for qualitative and quantitative analysis in HPLC, LC-MS, and other chromatographic methods.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating methods to monitor the level of this specific impurity in Vernakalant active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling & Characterization: Used in forced degradation studies and stability testing to understand the degradation pathways of Vernakalant and to establish appropriate specification limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive identification and control strategies for specified impurities as per ICH Q3A and Q3B guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to ensure API and drug product purity.
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this isomer during Vernakalant manufacturing.

Basic Information

Product Name	Vernakalant Impurity 1 ((3S,1'S,2'S)-Isomer) Hcl
CAS No.	795282-00-7
Molecular Formula	C20H30N2O3 • HCl
Molecular Weight	374.93 g/mol (Free base: 346.47 g/mol)
Synonyms	(3S,1'S,2'S)-Vernakalant Impurity 1 Hydrochloride; (3S,1'S,2'S)-Isomer of Vernakalant Related Compound; (2R,3R)-3-[(1S,2S)-2-(3,4-Dimethoxyphenethoxy)cyclohexylamino]-2-hydroxy-3,4-dihydro-2H-1-benzopyran-8-carbonitrile Hydrochloride; RS 795282-00-7; Vernakalant Stereoisomer Impurity; RSD 1195; RSD-1195; Vernakalant EP Impurity C
EINECS	Contact for details

Quality Control

Our Vernakalant Impurity 1 ((3S,1'S,2'S)-Isomer) Hcl is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral chromatography for stereochemical identity, and NMR/IR for structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided, supporting compliance with ICH guidelines and regulatory submission requirements.

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 COA. This compound 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 (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
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.