Description

Ketoconazole Impurity 4 is a designated impurity standard used in the analytical profiling of the antifungal active pharmaceutical ingredient, Ketoconazole. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference marker in chromatographic methods for the identification and quantification of related substances. Professionals in pharmaceutical R&D, quality assurance, and analytical chemistry rely on this high-purity standard for method development and validation.

Application

• Primary use as a certified reference standard for the analysis of Ketoconazole API and related formulations.
• Critical component in HPLC and LC-MS method development and validation for impurity profiling.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor degradation products.
• Used in regulatory compliance and submission packages to meet ICH, USP, and EP guidelines.
• Supports research and development (R&D) of Ketoconazole synthesis and purification processes.
• Valuable for academic and institutional research studying antifungal agents and their metabolites.

Basic Information

Product Name	Ketoconazole Impurity 4
CAS No.	170210-39-6
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 Related Compound; Ketoconazole EP Impurity D; Ketoconazole USP Related Compound; cis-Ketoconazole Dioxolane Acetylpiperazine Impurity; (2R,4S)- and (2S,4R)-1-Acetyl-4-(4-[[(2R,4S)- and (2S,4R)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl)piperazine
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. We support compliance with major pharmacopoeial standards (USP, EP) and ICH guidelines for impurities.

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. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.