Description

Acotiamide Related Compound (Ethyl 2-[(2-Hydroxy-4,5-Dimethoxybenzoyl)Amino]-4-Thiazolecarboxylate) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound, with CAS number 185106-05-2, serves as a key impurity marker and analytical standard in the development and validation of manufacturing processes for the gastrointestinal prokinetic agent Acotiamide. It is essential for laboratories requiring precise identification, quantification, and monitoring of related substances to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of related substances in Acotiamide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating HPLC, UPLC, and LC-MS/MS methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as an analytical marker to track degradation pathways and establish shelf-life for Acotiamide products under various storage conditions.
• Process Chemistry Research: Used in synthetic route development and optimization to understand and minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Acotiamide Related Compound (Ethyl 2-[(2-Hydroxy-4,5-Dimethoxybenzoyl)Amino]-4-Thiazolecarboxylate)
CAS No.	185106-05-2
Molecular Formula	C15H16N2O6S
Molecular Weight	352.36 g/mol
Synonyms	Ethyl 2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-1,3-thiazole-4-carboxylate; Acotiamide Impurity; Acotiamide Related Substance; 2-[(2-Hydroxy-4,5-dimethoxybenzoyl)amino]-4-thiazolecarboxylic Acid Ethyl Ester; YM443 Related Compound; 1,3-Thiazole-4-carboxylic acid, 2-[[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-, ethyl ester; Z-338 Related Compound
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality management systems. Each batch is characterized using advanced analytical techniques including NMR, MS, and HPLC to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) detailing purity, impurity profile, and analytical data, supporting compliance with ICH guidelines and cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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