Description

n-Desethyl Amodiaquine Dihydrochloride is a key pharmaceutical intermediate and reference standard of significant importance in analytical chemistry and drug development. Its primary value lies in its role as a major metabolite of the antimalarial drug Amodiaquine, making it essential for pharmacokinetic studies, bioanalytical method validation, and impurity profiling. This compound is critically needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of reference standards who require high-purity materials for regulatory compliance and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of the desethyl metabolite in drug substance and product testing.
• Metabolite Studies: Critical for in-vitro and in-vivo pharmacokinetic and metabolism studies of Amodiaquine, aiding in understanding drug efficacy and safety profiles.
• Impurity Profiling: Serves as a specified impurity standard in the quality control of Amodiaquine Active Pharmaceutical Ingredient (API) to ensure compliance with ICH guidelines.
• Bioanalytical Method Development: Employed as a calibration standard in HPLC, LC-MS, and LC-MS/MS methods for therapeutic drug monitoring and clinical trial sample analysis.
• Drug Development Research: Utilized in preclinical research to investigate the pharmacological activity and toxicity of Amodiaquine metabolites.

Basic Information

Product Name	n-Desethyl Amodiaquine Dihydrochloride
CAS No.	79352-78-6
Molecular Formula	C₂₁H₂₆Cl₃N₃O
Molecular Weight	442.81 g/mol
Synonyms	Desethylamodiaquine Dihydrochloride; N-Desethylamodiaquine 2HCl; 4-[(7-Chloro-4-quinolyl)amino]-2-[(diethylamino)methyl]phenol Dihydrochloride; Amodiaquine N-Desethyl Metabolite; BAY a 9141; NSC 339025; WR-184806; GSK369796 Dihydrochloride
EINECS	Contact for details

Quality Control

Our n-Desethyl Amodiaquine Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances and residual solvents in accordance with ICH guidelines. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to ensure full traceability and compliance for your regulatory needs.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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