Description

Itraconazole Impurity 25 is a designated impurity standard used in the pharmaceutical development and quality control of the antifungal drug Itraconazole. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Itraconazole drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity separation and detection.
• Stability Indicating Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of Itraconazole formulations.
• Quality Control & Batch Release: Essential for setting impurity specifications and conducting routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify the control strategy.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Itraconazole Impurity 25
CAS No.	89848-19-1
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound 25; Itraconazole EP Impurity 25; Itraconazole USP Impurity 25; (2R,4S,2'R)-2-Butyl-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]-1,3-dioxolan-4-yl]methyl]-2,4-dihydro-3H-1,2,4-triazol-3-one; Itraconazole Isomer; Itraconazole Process Impurity
EINECS	Contact for details

Quality Control

Our Itraconazole Impurity 25 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. Certificates of Analysis (COA) are provided, detailing comprehensive test results against established specifications. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B guidelines.

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 compound is hygroscopic (moisture-sensitive); 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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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