Description

Itraconazole Impurity 24 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 the antifungal active pharmaceutical ingredient (API) itraconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The use of this well-characterized impurity standard is essential for maintaining the stringent purity profiles demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in itraconazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures remain accurate and precise.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in itraconazole formulations under various storage conditions.
• Process Chemistry Research: Used by R&D chemists to study and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Itraconazole Impurity 24
CAS No.	219923-93-0
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound 24; Itraconazole EP Impurity I; Itraconazole USP Impurity; 1-[(2R,4S)-2-(2,4-Dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methyl]-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-δ2-1,2,4-triazolin-5-one; Itraconazole Dimer Impurity
EINECS	Contact for details

Quality Control

Every batch of Itraconazole Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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