Description

Atracurium Impurity 18 is a specified impurity and degradation product 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 profiling and quality control of Atracurium drug substances and products. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Atracurium Besylate active pharmaceutical ingredient (API) and finished formulations.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, primarily using HPLC and LC-MS techniques.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with strict regulatory specifications (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Atracurium Impurity 18
CAS No.	73841-84-6
Molecular Formula	C53H72N2O182+ • 2X-
Molecular Weight	Contact for details
Synonyms	Atracurium Related Compound H; Atracurium Besylate Impurity 18; Laudanosine Derivative; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium compound; Bis-quaternary ammonium impurity of Atracurium; Atracurium Degradant; Atracurium Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 18 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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