Description

Mivacurium Chloride Impurity 2 is a critical reference standard used in the analytical profiling and quality control of the neuromuscular blocking agent, Mivacurium Chloride. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Mivacurium Chloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A key component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Enables precise impurity profiling to ensure batches of Mivacurium Chloride meet stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Mivacurium Chloride Impurity 2
CAS No.	791546-70-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-[(3,4,5-trimethoxyphenyl)methyl]isoquinolinium Chloride (IUPAC); Mivacurium Chloride Related Compound; Mivacurium Impurity B; Mivacurium Chloride EP Impurity B; Mivacurium Chloride USP Impurity; BW B1090U Impurity
EINECS	Contact for details

Quality Control

Our Mivacurium Chloride Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment.

Specification

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

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