Description

Ketoconazole Impurity 20 is a specified impurity and reference standard used in the analytical profiling of the antifungal drug Ketoconazole. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products by serving as a benchmark in quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ketoconazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic chemistry research for impurity synthesis and characterization during process optimization.

Basic Information

Product Name	Ketoconazole Impurity 20
CAS No.	91458-32-1
Molecular Formula	C26H28Cl2N4O4
Molecular Weight	531.43 g/mol
Synonyms	Ketoconazole Related Compound 20; 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 EP Impurity 20; Ketoconazole USP Impurity 20; Ketoconazole Process Impurity; Impurity of Ketoconazole
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing chromatographic purity (HPLC), water content, residual solvents, and spectroscopic confirmation (IR, NMR, MS).

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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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