Description

Neostigmine Impurity 13 Metilsulfate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and analytical validation of Neostigmine, a widely used acetylcholinesterase inhibitor. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug safety, efficacy, and regulatory compliance. The precise characterization of such impurities is fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Neostigmine drug substances and products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical manufacturing to monitor impurity profiles and ensure product consistency.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in Neostigmine formulations under various stress conditions.
• Research & Development: Used in academic and industrial R&D settings for metabolic studies, degradation pathway elucidation, and synthesis process optimization.

Basic Information

Product Name	Neostigmine Impurity 13 Metilsulfate
CAS No.	64050-77-7
Molecular Formula	C13H22N2O6S
Molecular Weight	334.39 g/mol
Synonyms	Neostigmine Methyl Sulfate Impurity 13; 3-[[(Dimethylamino)carbonyl]oxy]-N,N,N-trimethylbenzenaminium Methyl Sulfate; m-Hydroxyphenyltrimethylammonium Methyl Sulfate Dimethylcarbamate; Benzenaminium, 3-[[(dimethylamino)carbonyl]oxy]-N,N,N-trimethyl-, methyl sulfate (1:1); Neostigmine Related Compound; Neostigmine Metilsulfate Impurity
EINECS	Contact for details

Quality Control

Every batch of Neostigmine Impurity 13 Metilsulfate is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, 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 each shipment, supporting compliance with cGMP and ICH guidelines.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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