Description

Ketoconazole Impurity 1 is a designated reference standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient, Ketoconazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ketoconazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Ketoconazole meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Aids in studying the metabolic pathways, degradation chemistry, and synthesis process of Ketoconazole.

Basic Information

Product Name	Ketoconazole Impurity 1
CAS No.	581806-59-9
Molecular Formula	C26H28Cl2N4O4
Molecular Weight	531.43 g/mol
Synonyms	Ketoconazole Related Compound A; 1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine; cis-1-Acetyl-4-[p-[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine; Ketoconazole Dioxolane Impurity; Ketoconazole EP Impurity A
EINECS	Contact for details

Quality Control

Our Ketoconazole Impurity 1 is manufactured and tested under strict quality management systems. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, and impurity content. Our quality standards align with the requirements for pharmaceutical reference materials.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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