Description

Atracurium Impurity 1 is a specified impurity of the neuromuscular blocking agent Atracurium Besylate, identified by CAS No. 41431-32-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Atracurium drug substances and products. 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 EP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Atracurium Impurity 1 in Atracurium Besylate active pharmaceutical ingredient (API) and finished formulations.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in the batch release testing of Atracurium to ensure compliance with regulatory specifications for impurity limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Used in research to understand the degradation mechanisms of Atracurium Besylate.

Basic Information

Product Name	Atracurium Impurity 1
CAS No.	41431-32-7
Molecular Formula	C53H72N2O12 • 2C7H8O3S
Molecular Weight	1243.5 g/mol
Synonyms	Atracurium Besylate Impurity 1; Atracurium Impurity A; Laudanosine Derivative; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate; (1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinoline) benzenesulfonate; 2-(3,4-Dimethoxyphenyl)ethyl]-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium benzenesulfonate; Atracurium Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 1 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and Mass Spectrometry.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 5.0%

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