Description

Atracurium Impurity D2 (cis-Quaternary Alcohol) is a critical pharmaceutical reference standard used in the analysis and quality control of the neuromuscular blocking agent, Atracurium Besylate. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a key marker for related substances testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing of injectable anesthetic drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Atracurium Besylate API and finished drug products.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Atracurium Impurity D2 (cis-Quaternary Alcohol)
CAS No.	1100676-16-1
Molecular Formula	C53H72N2O122+ • 2X-
Molecular Weight	Contact for details
Synonyms	1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium, compound with (1R,2R)-rel-2-(2-carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-isoquinolinium hydroxide (1:2), stereoisomer
Atracurium cis-Quaternary Alcohol Impurity
Atracurium Related Compound D2
cis-Atracurium Quaternary Alcohol Impurity
Bis-Quaternary Alcohol Impurity of Atracurium
Atracurium Besylate Impurity D2
2,2'-(1,5-Pentanediyl)bis[1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolinium] Diol
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity D2 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents and moisture content. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications developed for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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