Description

Hydroxy Itraconazole is a key pharmaceutical intermediate and metabolite of the broad-spectrum antifungal agent Itraconazole. This compound is critical for the development and quality control of antifungal medications, ensuring their efficacy and safety. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in antifungal drug synthesis, analytical method development, and metabolic studies.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Itraconazole and related triazole antifungal agents.
• Reference Standard: Used as a certified reference material (CRM) for analytical method validation, quality control, and regulatory compliance in pharmaceutical laboratories.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism, distribution, and excretion of Itraconazole.
• Impurity Profiling: Serves as a known impurity standard to monitor and control the quality of Itraconazole active pharmaceutical ingredient (API) and finished dosage forms.
• Research & Development: Employed in bioanalytical and preclinical studies to develop new formulations or derivative compounds with enhanced therapeutic profiles.

Basic Information

Product Name	Hydroxy Itraconazole
CAS No.	112559-91-8
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	2-Butanol, 1-[(1R,2R,4S)-4-[4-[4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-4,5-dihydro-2-propyl-1H-1,2,4-triazol-1-yl]-3-(hydroxy-); Itraconazole Hydroxy Metabolite; Itraconazole Metabolite R 63 312; Hydroxyitraconazole; R 63312; 1-[(1R,2R,4S)-4-[4-[4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-4,5-dihydro-2-propyl-1H-1,2,4-triazol-1-yl]-3-hydroxy-2-butanol
EINECS	Contact for details

Quality Control

Our Hydroxy Itraconazole is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%

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