Description

Itraconazole Impurity 12 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the antifungal drug Itraconazole, ensuring product safety and efficacy. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Itraconazole drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency of Itraconazole.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions as part of forced degradation and shelf-life studies.
• Research & Development: Used in synthetic chemistry research to study the metabolism and degradation pathways of Itraconazole.

Basic Information

Product Name	Itraconazole Impurity 12
CAS No.	308361-47-9
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound 12; (2R,4S,2'R)-2-Butyl-4-[[4-[4-[4-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]thio]-4-(1H-1,2,4-triazol-1-ylmethyl)-γ-butyrolactone; Itraconazole EP Impurity J; Itraconazole USP Related Compound J; UNII-2R5V8T8Q4J
EINECS	Contact for details

Quality Control

Every batch of Itraconazole Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

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%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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