Description

Acotiamide Impurity C is a designated impurity of the pharmaceutical agent Acotiamide, used as a critical reference standard in analytical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during manufacturing and regulatory submission processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation and impurity profiling.

Application

• Primary use as a pharmaceutical reference standard for Acotiamide.
• Critical component in analytical method development and validation (HPLC, LC-MS).
• Used for impurity identification and quantification in drug substance and drug product batches.
• Essential for stability studies and degradation pathway elucidation.
• Supports regulatory compliance and dossier preparation for agencies like the FDA and EMA.
• Valuable for research and development of Acotiamide and related compounds.

Basic Information

Product Name	Acotiamide Impurity C
CAS No.	1824734-16-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound C; Acotiamide EP Impurity C; Acotiamide USP Impurity C; YM443 Impurity C; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide Impurity; UNII-9J4JX1800F Impurity; Z-338 Impurity C
EINECS	Contact for details

Quality Control

Every batch of Acotiamide Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) providing detailed results for identity, purity, and impurity profile are available upon request, supporting your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material under appropriate laboratory conditions to maintain its stability and integrity as a reference standard.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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