Description

Acotiamide Impurity 7 is a designated reference standard used in the analytical profiling and quality control of the pharmaceutical compound Acotiamide. This high-purity impurity standard is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity for the identification and quantification of related substances in Acotiamide active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods, such as HPLC and UPLC, for impurity detection and control strategies.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure Acotiamide batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Acotiamide during synthesis and formulation processes.

Basic Information

Product Name	Acotiamide Impurity 7
CAS No.	185105-13-9
Molecular Formula	C21H26N4O4S
Molecular Weight	430.52 g/mol
Synonyms	N-[2-[Di(propan-2-yl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-1,3-thiazole-5-carboxamide; Acotiamide Related Compound 7; Acotiamide EP Impurity G; Acotiamide USP Impurity; Z-338 Impurity 7; YM443 Impurity 7; (5-Carbamoyl-1,3-thiazol-2-yl)-N-[2-[di(propan-2-yl)amino]ethyl]-2-hydroxy-4,5-dimethoxybenzamide
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% 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.