Description

Atracurium Impurity 19 is a critical pharmaceutical reference standard used in the analysis and quality control of the neuromuscular blocking agent, Atracurium Besylate. This compound, with CAS number 109717-73-9, is essential for ensuring the purity, safety, and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Atracurium Besylate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial standards (e.g., USP, EP) and regulatory specifications for impurity limits.
• Stability Studies: Used to track the formation of degradation products in Atracurium formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research & Development: Facilitates research into the degradation pathways and metabolism of Atracurium Besylate.

Basic Information

Product Name	Atracurium Impurity 19
CAS No.	109717-73-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atracurium Related Compound 19; Atracurium Besylate Impurity 19; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium; Laudanosine Methyl Methochloride; Laudanosine Methochloride; 6,7-Dimethoxy-2-methyl-1-veratryl-1,2,3,4-tetrahydroisoquinolinium Chloride; (1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium) Chloride
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 19 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and traceability are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent degradation.

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)	Complies with specification
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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