Description

Acotiamide Impurity 9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the development and manufacturing of the pharmaceutical agent Acotiamide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Acotiamide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection and quantification limits.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing within pharmaceutical QC laboratories to ensure product purity and compliance with ICH guidelines and pharmacopeial standards.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Acotiamide.
• Regulatory Submissions: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA), providing definitive characterization data for specified impurities.
• Research & Development: Supports synthetic chemistry research for understanding degradation pathways and optimizing manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Acotiamide Impurity 9
CAS No.	948053-83-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 9; Acotiamide EP Impurity I; Acotiamide USP Impurity; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide impurity; YM443 Impurity; Z-338 Impurity; ATC-002 Impurity
EINECS	Contact for details

Quality Control

Every batch of Acotiamide Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques including HPLC, GC, NMR, and MS.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere if specified.

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 ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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