Description

Mivacurium Chloride Impurity 23 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the neuromuscular blocking agent, Mivacurium Chloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The precise characterization of this impurity is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Mivacurium Chloride Impurity 23 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure drug substance and product purity meets specified limits.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification in regulatory filings to agencies such as the FDA, EMA, and other global health authorities.
• Research & Development: Supports investigative studies into the degradation pathways, metabolism, and pharmacokinetics of Mivacurium Chloride.

Basic Information

Product Name	Mivacurium Chloride Impurity 23
CAS No.	104758-47-6
Molecular Formula	C58H80N2O182+ • 2Cl-
Molecular Weight	1161.70 g/mol (for the dichloride salt)
Synonyms	1,2,3,4-Tetrahydro-2-(3-hydroxy-2,4-dimethoxyphenyl)-6,7-dimethoxy-2-methyl-1-[(3,4,5-trimethoxyphenyl)methyl]isoquinolinium Chloride (cis-isomer); Mivacurium Chloride Related Compound; Mivacurium Impurity C; (1R,1'R,2S,2'S)-2,2'-[1,8-Dioxo-4,9-dioxa-1,8-dodecanediyl)bis(oxy-3,1-propanediyl)]bis[1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-(3,4,5-trimethoxyphenyl)isoquinolinium] Dichloride Impurity; BW B1090U Impurity.
EINECS	Contact for details

Quality Control

Every batch of Mivacurium Chloride Impurity 23 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Impurity Profile (HPLC)	Single unidentified 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.