Description

Acotiamide Impurity 10 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the pharmaceutical Acotiamide, a prokinetic agent used in the treatment of functional dyspepsia. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of a specific impurity in Acotiamide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC testing to monitor impurity levels, ensuring every batch of Acotiamide API meets stringent pharmacopeial and internal specification limits.
• Stability Studies: Utilized as a reference to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate comprehensive control of the drug substance.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Acotiamide, supporting the development of more stable formulations.

Basic Information

Product Name	Acotiamide Impurity 10 Hcl
CAS No.	738562-93-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 10 Hydrochloride; Acotiamide Impurity 10 Hydrochloride Salt; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide Hydrochloride; YM443 Hydrochloride Impurity; Z-338 Impurity 10 HCl; (4-Carbamoyl-2-{[(2-hydroxy-4,5-dimethoxybenzoyl)amino]}thiazol-5-yl)-N,N-diisopropylethylammonium Chloride
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity 10 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with cGMP principles to support our clients' regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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