Description

Atovaquone Impurity 4 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 antipneumocystic drug, Atovaquone. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The material is supplied with comprehensive analytical data to support your research and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control of Atovaquone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies of Atovaquone to monitor impurity profiles over time.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for identification and qualification.
• Pharmacopoeial Testing: Used to test Atovaquone batches against stringent pharmacopoeial monographs (e.g., USP, EP) that specify limits for known impurities.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Atovaquone manufacturing.

Basic Information

Product Name	Atovaquone Impurity 4
CAS No.	2171347-18-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atovaquone Related Compound 4; Atovaquone Impurity D; Atovaquone EP Impurity D; Atovaquone USP Impurity 4; 2-(4-Chlorophenyl)-3-cyclohexyl-1,4-naphthoquinone Impurity; 1,4-Naphthoquinone, 2-(4-chlorophenyl)-3-cyclohexyl- (related impurity); Atovaquone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Atovaquone Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry and pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality assurance protocols.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. Keep the container sealed to protect this light-sensitive material from degradation.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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