Description

Acotiamide Impurity (CAS NO 198470-83-6) is a high-purity chemical reference standard critical for ensuring the quality and safety of pharmaceutical products. This compound serves as a key impurity or intermediate in the synthesis and analytical profiling of Acotiamide, a gastroprokinetic agent. It is essential for pharmaceutical manufacturers and analytical laboratories engaged in research, development, and quality control processes. The availability of this well-characterized impurity is fundamental for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Acotiamide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during manufacturing and stability testing.
• Process Chemistry & R&D: Employed as an intermediate or a marker in the research, development, and optimization of synthetic routes for Acotiamide.
• Quality Assurance/Quality Control (QA/QC): Integral for routine batch release testing to ensure drug substance and drug product meet stringent pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (heat, light, humidity) as per ICH guidelines.

Basic Information

Product Name	Acotiamide Impurity
CAS No.	198470-83-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide; Acotiamide Related Compound; Acotiamide Impurity Standard; YM443 Impurity; Z-338 Impurity
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with industry and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). Keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

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

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