Description

Neostigmine Impurity 8 Metilsulfate is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker in the quality control and analytical validation of Neostigmine Metilsulfate, a widely used acetylcholinesterase inhibitor. It is essential for laboratories in the pharmaceutical and fine chemical sectors requiring precise impurity profiling to ensure drug safety and regulatory compliance. The availability of this well-characterized standard supports method development and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Neostigmine Metilsulfate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Stability and Degradation Studies: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in pharmacopoeias such as USP, EP, and BP, where impurity limits are strictly defined.
• Research on Metabolism & Pharmacokinetics: Can be utilized in studies investigating the metabolic pathways and degradation profiles of Neostigmine-related compounds.

Basic Information

Product Name	Neostigmine Impurity 8 Metilsulfate
CAS No.	39218-17-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neostigmine Related Compound 8; 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 Methyl Sulfate Impurity 8
EINECS	Contact for details

Quality Control

Our Neostigmine Impurity 8 Metilsulfate is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, mass spectrometry, and NMR. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your quality assurance protocols and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
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.