Description

Itraconazole Impurity 24 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antifungal drug Itraconazole. This high-purity impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and contract testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Itraconazole Impurity 24 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Crucial for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Stability Studies: Used in forced degradation and long-term stability studies of Itraconazole to understand degradation pathways and establish shelf-life.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in routine QC testing to ensure every batch of Itraconazole API meets stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control and characterization.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes by tracking the formation and elimination of this specific impurity.

Basic Information

Item	Details
Product Name	Itraconazole Impurity 24
CAS No.	79538-91-3
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound 24; (2R,4S)-rel-1-(Butylcarbamoyl)-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-1H-1,2,4-triazol-1-ium-5-one; UNII-8X6Y1R8Q5R; 8X6Y1R8Q5R; Itraconazole Impurity K; Itraconazole EP Impurity K
EINECS	Contact for details

Quality Control

Every batch of Itraconazole Impurity 24 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced techniques including HPLC, NMR, and MS to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing identity, purity, and analytical results.

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) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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