Description

Atracurium Ep Impurity O is a high-purity chemical reference standard, specifically identified as a key process-related impurity in the synthesis of the neuromuscular blocking agent Atracurium Besylate. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control of the active pharmaceutical ingredient (API). It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of Atracurium Ep Impurity O in Atracurium Besylate API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to monitor impurity levels and ensure batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the API's impurity profile.
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize the formation of this impurity.

Basic Information

Product Name	Atracurium Ep Impurity O
CAS No.	119403-01-9
Molecular Formula	C53H72N2O12 • 2C18H34O2
Molecular Weight	1479.94 g/mol
Synonyms	1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium, (1R,2R)-2-(3,4-dimethoxyphenyl)-1-[[1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-isoquinolinyl]carbonyloxy]ethyl ester dibenzenesulfonate; Atracurium Impurity O; Atracurium Besylate Impurity O; (1R,2R)-2-(3,4-Dimethoxyphenyl)-1-((6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-1-yl)carbonyloxy)ethyl 2-(3,4-dimethoxyphenyl)acetate dibenzenesulfonate; Ep Atracurium Impurity O
EINECS	Contact for details

Quality Control

Our Atracurium Ep Impurity O is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) detailing purity, assay, and impurity profiles, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive; prolonged exposure to light should be avoided to maintain stability and purity. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0% w/w

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