Description

Mivacurium Chloride Impurity 1 (CAS No. 733704-04-6) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control of Mivacurium Chloride, a non-depolarizing neuromuscular blocking agent. It is essential for analytical method development, validation, and ensuring the safety and efficacy of the final drug product. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this standard for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Mivacurium Chloride Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Mivacurium Chloride batches.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to ensure Mivacurium Chloride meets the purity specifications outlined in pharmacopeias (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filings: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Mivacurium Chloride.

Basic Information

Product Name	Mivacurium Chloride Impurity 1
CAS No.	733704-04-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,3R,1'R,2'S)-2-(3,4-Dimethoxyphenyl)-1-[(3,4-dimethoxyphenethyl)amino]-2-methyl-3-(1-piperidinyl)-1-propanone; Mivacurium Chloride Related Compound A; Mivacurium Impurity A; Mivacurium Chloride EP Impurity A; Mivacurium Chloride USP Impurity 1; (1R,2S)-1-(3,4-Dimethoxyphenethyl)-2-methyl-3-oxo-3-(1-piperidinyl)propyl 2,3-dimethoxybenzoate Impurity
EINECS	Contact for details

Quality Control

Our Mivacurium Chloride Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.