Description

Atovaquone Impurity 6 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 serves as a key impurity marker for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and stability testing. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Atovaquone API and finished drug products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug synthesis and purification.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Atovaquone meets pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of degradation products in Atovaquone under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, CMC sections) by providing characterized impurity data for health authorities like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Atovaquone Impurity 6
CAS No.	1368590-16-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atovaquone Related Compound 6; Atovaquone EP Impurity 6; Atovaquone USP Impurity 6; 2-(4-Chlorophenyl)-3-cyclohexyl-1,4-naphthoquinone Impurity; Atovaquone Process Impurity; Atovaquone Degradant; 1,4-Naphthoquinone, 2-(4-chlorophenyl)-3-cyclohexyl- (related substance)
EINECS	Contact for details

Quality Control

Every batch of Atovaquone Impurity 6 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 pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

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 should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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