Description

Acotiamide Impurity 17 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the accurate identification, quantification, and control of process-related impurities during the manufacturing of Acotiamide, a gastroprokinetic agent. It is an essential material for pharmaceutical quality control laboratories and analytical chemists working on method development and validation. Ensuring the integrity of this impurity standard is fundamental to meeting stringent regulatory requirements for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for impurity profiling and method validation in Acotiamide API production.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for the separation and detection of Acotiamide-related substances.
• Quality Control & Assurance: Serves as a system suitability and identification standard in routine QC testing to ensure batch-to-batch consistency and purity of the final drug product.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Acotiamide formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Acotiamide Impurity 17
CAS No.	1190537-60-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 17; Acotiamide Impurity C; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide impurity; UNII-7F3K1B717T; 4-Thiazolecarboxamide, N-[2-[bis(1-methylethyl)amino]ethyl]-2-[[(2-hydroxy-4,5-dimethoxyphenyl)carbonyl]amino]-; 1190537-60-0; Acotiamide EP Impurity C
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

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 hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.