Description

Atracurium Impurity 8 is a specified impurity associated with 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 for method validation, stability studies, and ensuring batch-to-batch consistency and compliance with stringent pharmacopeial 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 guidelines.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): A critical component in the routine testing of Atracurium Besylate API to monitor and control impurity levels.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) documents by providing impurity characterization data.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Atracurium Impurity 8
CAS No.	1100676-20-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium; Laudanosine Methyl Chloride Quaternary Salt; Atracurium Related Compound; Laudanosine Methochloride; Atracurium Degradant; Norlaudanosine Methyl Chloride Quaternary Salt; 6,7-Dimethoxy-2-methyl-1-veratryl-1,2,3,4-tetrahydroisoquinolinium chloride
EINECS	Contact for details

Quality Control

Our Atracurium Impurity 8 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, NMR), and residual solvent screening to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.