Description

Ketoconazole Impurity 18 is a designated reference standard used in the analytical profiling of the antifungal pharmaceutical agent, Ketoconazole. This compound is critical for ensuring the purity, safety, and efficacy of Ketoconazole drug substances and finished products by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical quality control laboratories, research institutions, and regulatory bodies involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Ketoconazole Active Pharmaceutical Ingredient (API) and formulations.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurities during manufacturing and stability testing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Facilitates studies on the degradation pathways and chemical behavior of Ketoconazole, supporting process improvement and new formulation development.

Basic Information

Product Name	Ketoconazole Impurity 18
CAS No.	1610851-14-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoconazole Related Compound 18; Ketoconazole EP Impurity 18; Ketoconazole USP Impurity 18; 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 (IUPAC-based); Impurity of Ketoconazole; Ketoconazole Degradation Product; Ketoconazole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR 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 and confirming compliance with relevant guidelines.

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 is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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