Description

Ketoconazole Impurity 17 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 an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ketoconazole API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of degradation products in Ketoconazole formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in academic and industrial research to study the metabolic pathways, degradation mechanisms, and synthesis impurities related to Ketoconazole.

Basic Information

Product Name	Ketoconazole Impurity 17
CAS No.	2095256-87-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoconazole Related Compound 17; Ketoconazole EP Impurity 17; Ketoconazole USP Impurity 17; Ketoconazole Degradation Product 17; Ketoconazole Process Impurity 17; (2R,4S)-rel-2-(2,4-Dichlorophenyl)-2-[(1H-imidazol-1-yl)methyl]-4-[[4-(phenylmethoxy)phenyl]methyl]-1,3-dioxolane (Potential IUPAC-like name based on structure); 1,3-Dioxolane derivative of Ketoconazole
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.