Description

Ketoconazole Impurity 7 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 antifungal active pharmaceutical ingredient (API) Ketoconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Ketoconazole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified pharmacopeial limits.
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Ketoconazole formulations.
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical behavior of Ketoconazole under various conditions.

Basic Information

Product Name	Ketoconazole Impurity 7
CAS No.	172032-21-2
Molecular Formula	C26H28Cl2N4O4
Molecular Weight	531.43 g/mol
Synonyms	1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine; Ketoconazole Dioxolane Impurity; Ketoconazole Related Compound 7; cis-Ketoconazole; (2R,4S)-Ketoconazole; Ketoconazole Impurity C (EP); Ketoconazole European Pharmacopoeia Impurity C
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive testing includes HPLC for assay and related substances, along with spectroscopic confirmation (IR, NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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