Description

Acotiamide Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Acotiamide through rigorous impurity profiling and method validation. It is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The material is characterized by its specific chemical structure and properties, which are vital for accurate identification and quantification.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Acotiamide API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies to monitor degradation pathways and establish shelf-life for Acotiamide formulations.
• Essential for regulatory compliance and submission (e.g., ICH guidelines Q3A, Q3B) to demonstrate impurity control.
• Serves as a key material in pharmaceutical research for studying the metabolism and pharmacokinetics of Acotiamide.
• Supports calibration of laboratory equipment to ensure accurate and reproducible analytical results.
• Used by contract research organizations (CROs) and quality assurance departments for batch release testing.

Basic Information

Product Name	Acotiamide Impurity
CAS No.	877998-00-0
Molecular Formula	C21H26N4O4S
Molecular Weight	430.52 g/mol
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; (4-Carbamoyl-2-thiazolyl)-[2-(diisopropylamino)ethyl]amine Derivative; 2-[[(2-Hydroxy-4,5-dimethoxybenzoyl)amino]-N-[2-(diisopropylamino)ethyl]-1,3-thiazole-4-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Acotiamide Impurity (CAS 877998-00-0) 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 conformity to the highest pharmaceutical reference standard grades. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and impurity profile, is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry, and well-ventilated place away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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