Description

Atracurium Impurity 21 is a key chemical reference standard used in the pharmaceutical development and quality control of neuromuscular blocking agents. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient atracurium besylate. It is primarily utilized by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and regulatory compliance testing for injectable formulations.

Application

• Pharmaceutical Impurity Profiling and Identification in the analysis of Atracurium Besylate API and its formulations.
• Method Development and Validation for HPLC, UPLC, and other chromatographic techniques in QC laboratories.
• Stability-Indicating Studies to monitor degradation pathways and establish shelf-life for pharmaceutical products.
• Regulatory Submission and Compliance, providing essential data for FDA, EMA, and other global health authority filings.
• Calibration Standard for quantitative impurity analysis to ensure batch-to-batch consistency.
• Research and Development of new analytical methods and synthesis pathways for neuromuscular blocking agents.

Basic Information

Product Name	Atracurium Impurity 21
CAS No.	96946-43-9
Molecular Formula	C53H72N2O12
Molecular Weight	929.15 g/mol
Synonyms	Atracurium Related Compound 21; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium, 1-[3,4-bis(acetyloxy)phenyl]-2-morpholino-1-propanone ester; Laudanosine derivative; Atracurium Degradant; Bis-benzylisoquinolinium impurity
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 21 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and desiccated upon opening 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 standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Assay	90.0% - 110.0% (on anhydrous basis)

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