Description

Acotiamide Impurity 29 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and regulatory compliance of Acotiamide, a medication used to treat functional dyspepsia. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure product safety and efficacy. The use of this well-characterized impurity standard is fundamental for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Acotiamide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Acotiamide.

Basic Information

Item	Details
Product Name	Acotiamide Impurity 29
CAS No.	1894752-74-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 29; Acotiamide Impurity F; Acotiamide EP Impurity F; Acotiamide USP Impurity; (2S)-2-[(2-Hydroxy-4,5-dimethoxybenzoyl)amino]-N,N-diethyl-4,5-dimethoxybenzamide Impurity; Z-338 Impurity 29; YM443 Impurity 29
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity 29 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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