Description

Acotiamide Impurity 39 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization, method validation, and quality control of the gastrointestinal prokinetic drug Acotiamide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

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 dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical system suitability component to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize and purify the parent drug substance.

Basic Information

Product Name	Acotiamide Impurity 39
CAS No.	27867-46-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 39; Acotiamide Impurity F; Acotiamide EP Impurity F; Acotiamide USP Impurity; 2-[(2R)-2-[(2-Hydroxy-5-methoxybenzoyl)amino]propyl]-4-(morpholin-4-yl)-1,3-thiazole-5-carboxylic acid (probable IUPAC); YM443 Impurity; Z-338 Impurity; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Acotiamide Impurity 39 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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