Description

Atracurium Impurity 15 Iodide (Cisatracurium Besilate EP Impurity O Iodide) is a high-purity reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in the synthesis of the neuromuscular blocking agent Cisatracurium Besylate. It is primarily required by analytical laboratories, regulatory affairs departments, and R&D teams within the pharmaceutical industry to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Cisatracurium Besylate API and finished drug products.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (HPLC, UPLC) for the precise separation and detection of this specific impurity.
• Stability Studies: Employed as a marker to track impurity profiles and assess the degradation pathways of Cisatracurium Besylate under various storage conditions.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Pharmaceutical R&D: Used in process chemistry research to understand and minimize the formation of this impurity during synthesis and purification steps.
• Contract Testing Laboratory Analysis: Supplied to CROs and CMOs for third-party verification and batch release testing of pharmaceutical materials.

Basic Information

Product Name	Atracurium Impurity 15 Iodide (Cisatracurium Besilate EP Impurity O Iodide)
CAS No.	155913-31-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cisatracurium Besylate Impurity O Iodide; Atracurium Impurity 15; (1R,2R)-1-(3,4-Dimethoxyphenyl)-2-methyl-6,7-dimethoxy-1,2,3,4-tetrahydroisoquinolin-2-ium Iodide; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-(3,4-dimethoxyphenyl)isoquinolinium Iodide; Laudanosine Iodide Derivative; EP Impurity O of Cisatracurium Besilate; Process Impurity of Cisatracurium
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 15 Iodide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and mass spectrometry analyses.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
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.