Description

Acotiamide Impurity 5 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 drug substance Acotiamide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine quality control testing of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Acotiamide drug substance and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC.
• Quality Control (QC) & Quality Assurance (QA): Essential for routine batch release testing in pharmaceutical manufacturing to ensure product purity meets pharmacopeial standards (e.g., ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Acotiamide under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies, pharmacokinetic research, and to understand the degradation pathways of the parent drug molecule.

Basic Information

Product Name	Acotiamide Impurity 5
CAS No.	206882-15-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acotiamide Related Compound 5; Acotiamide EP Impurity 5; Acotiamide USP Impurity 5; YM443 Impurity; N-[2-[Bis(1-methylethyl)amino]ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamide Impurity; 4,5-Dimethoxysalicylamide derivative of Acotiamide; ATC Impurity 5
EINECS	Contact for details

Quality Control

Our Acotiamide Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification (IR, NMR, MS), to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

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%
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.