Description

Acotiamide Impurity 6 Maleate is a high-purity chemical 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 by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments engaged in method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Acotiamide drug substance and drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and quantification.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a benchmark to identify and track degradation products in forced degradation and long-term stability studies of Acotiamide formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and specifications.
• Pharmacopoeial Testing: Supports testing to meet monograph requirements of various pharmacopoeias (e.g., USP, EP, JP).
• Research & Synthesis: Serves as a building block or intermediate in chemical synthesis research for related compounds.

Basic Information

Product Name	Acotiamide Impurity 6 Maleate
CAS No.	185103-81-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 6 Maleate; Acotiamide Maleate Impurity 6; Acotiamide EP Impurity 6 Maleate; Acotiamide USP Impurity 6 Maleate; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide maleate; Z-338 Impurity 6 Maleate; YM443 Impurity 6 Maleate
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity 6 Maleate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The original container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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