Description

Atracurium Impurity 25 is a specified impurity of the neuromuscular blocking agent Atracurium Besylate. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Atracurium Besylate impurities in compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Atracurium Besylate API to monitor and control impurity levels, ensuring batch-to-batch consistency.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Atracurium Besylate to improve formulation and packaging strategies.

Basic Information

Product Name	Atracurium Impurity 25
CAS No.	86682-55-5
Molecular Formula	C53H72N2O12 • 2C20H14O4
Molecular Weight	Contact for details
Synonyms	Atracurium Besylate Impurity 25; Laudanosine Derivative; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate; Bisbenzylisoquinolinium compound; Atracurium Related Compound 25; (1R,2R)-2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate salt
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 25 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the needs of pharmaceutical development, with testing typically including HPLC purity, related substances, residual solvents, and identity confirmation by spectroscopic methods. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.