Description

Atovaquone 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 antimalarial and antipneumocystis drug, Atovaquone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Atovaquone Impurity 5 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Used in research and quality control laboratories to develop, optimize, and validate analytical methods, primarily HPLC and LC-MS.
• Stability Studies: Employed as a marker to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of Atovaquone formulations.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity profiles and control strategies as per ICH guidelines.
• Quality Control Testing: Used in routine batch release testing of Atovaquone API to ensure impurity levels remain within specified safety limits.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Atovaquone to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Atovaquone Impurity 5
CAS No.	1368749-51-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atovaquone Related Compound 5; Atovaquone EP Impurity 5; Atovaquone USP Impurity 5; 2-(4-Chlorophenyl)-3-cyclohexyl-1,4-naphthoquinone Impurity; Degradation Product of Atovaquone; Atovaquone Process Impurity; Atovaquone Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Atovaquone Impurity 5 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.