Description

Cisatracurium-20-Methyl Dibenzenesulfonate is a key pharmaceutical intermediate and reference standard of significant importance in the synthesis and quality control of neuromuscular blocking agents. This high-purity compound is critical for ensuring the efficacy and safety of pharmaceutical formulations. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in the development, production, and regulatory compliance of advanced anesthetic and muscle relaxant drugs.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Cisatracurium besylate and related neuromuscular blocking agents.
• Analytical Reference Standard: Used for method development, validation, and quality control (QC) testing in pharmaceutical analysis via HPLC, LC-MS, or other chromatographic techniques.
• Impurity Standard: Serves as a certified reference material for identifying and quantifying related substances and degradation products in active pharmaceutical ingredient (API) batches.
• Research & Development: Employed in preclinical and clinical research to study the pharmacology, metabolism, and stability of cisatracurium-based compounds.
• Regulatory Compliance: Essential for generating data to meet the stringent requirements of regulatory bodies like the FDA, EMA, and ICH for drug master files (DMFs) and new drug applications (NDAs).
• Process Chemistry: Used in scaling up and optimizing manufacturing processes for non-depolarizing muscle relaxants.

Basic Information

Product Name	Cisatracurium-20-Methyl Dibenzenesulfonate
CAS No.	1193104-85-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[17-(Acetyloxy)-3-hydroxy-2-(4-morpholinyl)-10,13-dioxo-16-(2- piperidinyl)-4,11-diazanonadec-8-en-6-yl]-1-(2,3,4,5,6-pentahydroxyhexyl)-2,3,4,5,6-pentahydroxy-1,5-imidazolium dibenzenesulfonate; 20-Methyl Cisatracurium Dibenzenesulfonate; (1R,2R)-1-(3,4-Dimethoxyphenethyl)-2-(4-hydroxybenzyl)-6,7-dimethoxy-1,2,3,4-tetrahydroisoquinolin-2-ium dibenzenesulfonate (related isomer); Cisatracurium Methyl Ester Dibenzenesulfonate Salt; Nimbex Intermediate; Neuromuscular Blocker Intermediate.
EINECS	Contact for details

Quality Control

Our Cisatracurium-20-Methyl Dibenzenesulfonate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identity confirmation, purity assay, and impurity profiling, to ensure it meets the high standards required for pharmaceutical development and manufacturing. Certificates of Analysis (COA) with detailed chromatographic data (HPLC/LC-MS) are provided and can be tailored to support specific regulatory submissions under ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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