Description

Ketoconazole Impurity 25 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Ketoconazole, a widely used antifungal API. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The product is supplied with comprehensive analytical data to support your research and compliance needs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Ketoconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and characterize Ketoconazole impurities for regulatory filings (e.g., ICH guidelines).
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Ketoconazole formulations under various stress conditions.
• Pharmacopoeial Testing: Supports testing in compliance with USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopoeial monographs for Ketoconazole.
• Regulatory Compliance & Documentation: Essential for preparing impurity profiles and regulatory submission documents (e.g., for FDA, EMA) to demonstrate product safety.
• Research & Development: Used in synthetic chemistry and metabolic studies to understand the degradation pathways and impurity fate of Ketoconazole.

Basic Information

Item	Detail
Product Name	Ketoconazole Impurity 25
CAS No.	1253852-50-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ketoconazole Related Compound 25; Ketoconazole EP Impurity I; Ketoconazole USP Impurity; 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); Ketoconazole Degradant; Ketoconazole Process Impurity; Antifungal Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Ketoconazole Impurity 25 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. We support compliance with cGMP and relevant pharmacopoeial guidelines (USP/EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 individual unknown impurity ≤ 1.0%
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.