Description

Ketoconazole Impurity 15 is a designated chemical reference standard used in the analysis and quality control of the antifungal pharmaceutical, Ketoconazole. This compound is critical for ensuring the purity, safety, and efficacy of Ketoconazole drug substances and finished products by serving as a known benchmark in chromatographic and spectroscopic methods. It is an essential material for analytical laboratories and pharmaceutical manufacturers engaged in research, development, and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Ketoconazole Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products in Ketoconazole under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis pathway studies.

Basic Information

Product Name	Ketoconazole Impurity 15
CAS No.	98207-06-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoconazole Related Compound; Ketoconazole EP Impurity; Ketoconazole USP Impurity; 1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine (IUPAC); Ketoconazole Dimer; Ketoconazole Process Impurity; Ketoconazole Degradant
EINECS	Contact for details

Quality Control

Our Ketoconazole Impurity 15 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided to support your regulatory and quality 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). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which could affect stability and purity.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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