Description

Lumefantrine Keto Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of antimalarial drugs. This specific impurity is critical for ensuring the purity, safety, and efficacy of Lumefantrine API and its formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lumefantrine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Lumefantrine-based medications meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Compliance & Filings: A necessary component in regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development (R&D): Utilized in synthetic chemistry research to understand and minimize impurity formation during the Lumefantrine manufacturing process.

Basic Information

Product Name	Lumefantrine Keto Impurity
CAS No.	53221-25-3
Molecular Formula	C30H32Cl3NO
Molecular Weight	528.94 g/mol
Synonyms	Lumefantrine Ketone; Lumefantrine Related Compound K; 2,7-Dichloro-9-[(4-chlorophenyl)(dibutylamino)methyl]fluoren-9-one; Benflumetol Keto Impurity; 9-[(4-Chlorophenyl)(dibutylamino)methyl]-2,7-dichlorofluoren-9-one; Coartem Impurity K; Lumefantrine Impurity K; ARCO Impurity K
EINECS	Contact for details

Quality Control

Our Lumefantrine Keto Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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