Description

Neostigmine Impurity 1 is a specified impurity and a key reference standard used in the analytical profiling of the pharmaceutical compound Neostigmine. This high-purity chemical is critical for ensuring the safety, efficacy, and regulatory compliance of Neostigmine drug substances and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and quality control units for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Neostigmine active pharmaceutical ingredient (API) and formulations.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine quality control testing to ensure Neostigmine batches meet pharmacopeial (USP, EP, BP) or internal purity specifications.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of Neostigmine.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Utilized in R&D to study the synthesis pathways, degradation mechanisms, and metabolic profiles of Neostigmine.

Basic Information

Product Name	Neostigmine Impurity 1
CAS No.	4312-54-3
Molecular Formula	C₁₂H₁₉N₂O₂⁺
Molecular Weight	223.29 g/mol
Synonyms	3-[(Dimethylamino)carbonyloxy]-N,N,N-trimethylbenzenaminium; m-Hydroxyphenyltrimethylammonium dimethylcarbamate; Neostigmine Related Compound A; Neostigmine Methylsulfate Impurity; Benzenaminium, 3-[[(dimethylamino)carbonyl]oxy]-N,N,N-trimethyl-; m-(Trimethylammonio)phenyl dimethylcarbamate
EINECS	Contact for details

Quality Control

Every batch of Neostigmine Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.