Description

Acotiamide Impurity 8 Maleate is a high-purity reference standard specifically used in the pharmaceutical development and quality control of Acotiamide. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in Acotiamide analysis.
• Method Development and Validation: Critical component in developing and validating chromatographic methods to separate, identify, and quantify impurities.
• Quality Control (QC) and Quality Assurance (QA): Used in routine batch testing of Acotiamide Active Pharmaceutical Ingredient (API) to monitor and control impurity levels against ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides essential data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to understand and minimize impurity formation.

Basic Information

Item	Details
Product Name	Acotiamide Impurity 8 Maleate
CAS No.	185105-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 8 Maleate; Acotiamide Maleate Impurity 8; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide Maleate; YM443 Maleate Impurity 8; Z-338 Impurity 8 Maleate; (Z)-But-2-enedioic acid compound with N-[2-[bis(propan-2-yl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-1,3-thiazole-4-carboxamide
EINECS	Contact for details

Quality Control

Every batch of Acotiamide Impurity 8 Maleate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.