Description

Acotiamide Impurity 31 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the gastroprokinetic drug Acotiamide hydrochloride hydrate. It is primarily utilized by analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Acotiamide drug substance and finished products.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, to monitor impurity levels.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure drug products meet stringent purity specifications set by pharmacopeias (e.g., ICH Q3A/B).
• Stability Studies: Employed to identify and quantify degradation products that may form during drug product storage and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Acotiamide Impurity 31
CAS No.	5981-37-3
Molecular Formula	C21H26N4O4S
Molecular Weight	430.52 g/mol
Synonyms	N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-1,3-thiazole-4-carboxamide; Acotiamide Related Compound; YM443 Impurity; UNII-9F6Q8S3A3S; 4-Thiazolecarboxamide, N-[2-[bis(1-methylethyl)amino]ethyl]-2-[[(2-hydroxy-4,5-dimethoxyphenyl)carbonyl]amino]-; Z-338 Impurity
EINECS	Contact for details

Quality Control

Every batch of Acotiamide Impurity 31 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency in line with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications.

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 ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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