Description

Itraconazole Impurity 17 is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API) Itraconazole. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Itraconazole Impurity 17 in Itraconazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API batches comply with stringent pharmacopeial limits (e.g., ICH Q3A/B, USP, EP) for specified impurities.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Aids in synthetic route optimization and process chemistry to understand and minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Itraconazole Impurity 17
CAS No.	854372-78-4
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound 17; (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-5-one; Itraconazole EP Impurity G; Itraconazole USP Related Compound C; Itraconazole Process Impurity; 1,3-Dioxolane, 2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-4-[[4-[4-[4-[[4-butyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-yl]carbonyl]amino]phenyl]-1-piperazinyl]phenoxy]methyl]-, (2R-cis)-
EINECS	Contact for details

Quality Control

Our Itraconazole Impurity 17 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes data on assay, related substances, and residual solvents, ensuring compliance with ICH guidelines and relevant pharmacopeial standards. Our quality commitment supports your regulatory and cGMP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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