Description

Mivacurium Chloride Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the neuromuscular blocking agent, Mivacurium Chloride, by serving as a key marker for impurity profiling. It is an essential material for pharmaceutical quality control laboratories, analytical chemists, and researchers involved in method development, stability studies, and regulatory compliance. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for pharmaceutical active ingredients.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Mivacurium Chloride.
• Impurity Identification and Control: Critical for method development and validation in HPLC and LC-MS assays to monitor and control specified and unspecified impurities.
• Stability Indicating Method: Used in forced degradation studies to identify and quantify degradation products of Mivacurium Chloride under various stress conditions.
• Pharmacopeial Compliance: Supports testing to meet the requirements of USP, EP, ICH Q3A/B, and other regulatory guidelines for impurity limits in new drug substances and products.
• Research and Development: Aids in the study of the degradation pathways, metabolism, and synthesis of Mivacurium Chloride and related compounds.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing.

Basic Information

Product Name	Mivacurium Chloride Impurity 3
CAS No.	740777-60-0
Molecular Formula	C58H80N2O182+ • 2Cl-
Molecular Weight	1162.70 g/mol (for the dichloride salt)
Synonyms	(2S,3S,5S,16S,17S,19S)-3,17-Bis(acetyloxy)-16-(3,4-dimethoxyphenyl)-2-(1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-isoquinolinyl)-10,23-dioxo-9,12,15,18,22-pentaoxa-8,11,14,17,20-pentaazatetratriacontan-34-yl 3,4-dimethoxybenzoate dichloride; Mivacurium Chloride Related Compound C; Mivacurium Impurity C; Mivacurium Chloride EP Impurity C; Mivacurium Chloride USP Impurity; BW B1090U Impurity; A bis-tetrahydroisoquinolinium diester impurity.
EINECS	Contact for details

Quality Control

Our Mivacurium Chloride Impurity 3 is manufactured under strict quality systems to ensure identity, purity, and consistency. Each batch is comprehensively characterized using advanced analytical techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for assay, purity, and identification against a certified reference standard. Our quality commitment aligns with the principles of GMP and ICH guidelines for pharmaceutical impurities.

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. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 95.0%
Assay (by HPLC)	≥ 90.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 5.0%

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