Description

Mivacurium Chloride Impurity 4 is a high-purity chemical reference standard critical for pharmaceutical analysis and quality control. This compound is essential for ensuring the safety and efficacy of the neuromuscular blocking agent, Mivacurium Chloride, by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material for the qualitative and quantitative analysis of impurities in Mivacurium Chloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor process-related impurities.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure drug substance and product batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of degradation products in Mivacurium Chloride formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and metabolic pathways of Mivacurium Chloride.

Basic Information

Product Name	Mivacurium Chloride Impurity 4
CAS No.	714192-43-5
Molecular Formula	C58H80N2O142+ • 2Cl-
Molecular Weight	1080.70 g/mol (for the dichloride salt)
Synonyms	1,2,3,4-Tetrahydro-2-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-1-[(3,4,5-trimethoxyphenyl)methyl]isoquinolinium Chloride (trans-trans Isomer); Mivacurium Chloride Related Compound C; Mivacurium Impurity C; Mivacurium Chloride Impurity C; Mivacurium Related Substance C; BW B1090U Impurity 4; (1R,1'R,2S,2'S)-2,2'-Dimethyl-1,1'-bis(3,4,5-trimethoxybenzyl)-6,6',7,7'-tetramethoxy-1,1',2,2',3,3',4,4'-octahydro-1,1'-bisoquinolinium Dichloride (trans,trans isomer)
EINECS	Contact for details

Quality Control

Our Mivacurium Chloride Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques including HPLC, NMR, and MS. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.