Description

Itraconazole Impurity CAS NO 89848-54-4 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 focused on quality control and compliance. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards and advancing pharmaceutical development.

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 & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency in API manufacturing.
• Regulatory Compliance & Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Itraconazole.
• Research & Development: Facilitates chemical and metabolic research related to Itraconazole, including studies on synthesis pathways and degradation mechanisms.

Basic Information

Product Name	Itraconazole Impurity
CAS No.	89848-54-4
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound; Itraconazole EP Impurity; Itraconazole USP 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; (2R,4S)-rel-2-(2,4-Dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methyl 4-[4-[4-[4-[[(1S)-1-methylpropyl]-3-oxo-2,4-dihydro-1,2,4-triazol-4-yl]phenyl]-1-piperazinyl]phenoxy]acetate
EINECS	Contact for details

Quality Control

Our Itraconazole Impurity is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch undergoes comprehensive analytical testing, including HPLC for purity determination and spectroscopic confirmation (IR, NMR, MS) for structural identity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results and is compliant with current Good Manufacturing Practice (cGMP) principles for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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

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