Description

Esketamine Hydrochloride Ep Impurity B is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the development and manufacturing of Esketamine Hydrochloride, an important active pharmaceutical ingredient. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and quality control departments to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Esketamine Hydrochloride drug substance and finished products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control & Release Testing: Employed in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and impurity profile.
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during synthesis.

Basic Information

Product Name	Esketamine Hydrochloride Ep Impurity B
CAS No.	1823362-29-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride impurity B; Esketamine EP Impurity B; (S)-Ketamine Impurity B; Esketamine Related Compound B; ESK-HCl Impurity B; ARK-IMP-B (proposed); 1823362-29-3
EINECS	Contact for details

Quality Control

Our Esketamine Hydrochloride Ep Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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