Description

Itraconazole Impurity CAS NO 172587-60-9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antifungal drug Itraconazole by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in quality control, research and development, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Itraconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Itraconazole analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Facilitates studies on the metabolism, degradation pathways, and synthesis of Itraconazole and related compounds.

Basic Information

Product Name	Itraconazole Impurity
CAS No.	172587-60-9
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound; Itraconazole Specified Impurity; 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]piperazin-1-yl]phenyl]-2,4-dihydro-2-[(1S)-1-methylpropyl]-3H-1,2,4-triazol-3-one; UNII-4W5P6UQ9QN
EINECS	Contact for details

Quality Control

Our Itraconazole Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for GMP-regulated environments and critical research applications.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation. Keep away from incompatible materials.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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