Description

Ketoconazole Impurity 6 CAS NO 1610851-15-4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Ketoconazole, a widely used antifungal API. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Ketoconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods (HPLC, UPLC) for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and meet ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor and quantify the formation of this specific degradation product during forced degradation and long-term stability testing of Ketoconazole formulations.
• Research & Development: Used in R&D to study the degradation pathways, metabolism, and chemical behavior of Ketoconazole.
• Quality Control Testing: Acts as a system suitability and identification standard in the routine QC release testing of Ketoconazole batches.

Basic Information

Product Name	Ketoconazole Impurity 6
CAS No.	1610851-15-4
Molecular Formula	C26H28Cl2N4O4
Molecular Weight	531.43 g/mol
Synonyms	Ketoconazole Related Compound 6; Ketoconazole EP Impurity 6; Ketoconazole USP Impurity 6; 1-[4-(4-{[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one; Ketoconazole Degradation Product; Ketoconazole Process Impurity
EINECS	Contact for details

Quality Control

Our Ketoconazole Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for a reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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