Description

Itraconazole Impurity 26 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal active pharmaceutical ingredient (API) Itraconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Itraconazole Impurity 26 in Itraconazole API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control laboratories to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profile data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Itraconazole to understand degradation pathways and establish shelf-life.
• Research & Development: Used in pharmaceutical R&D for studying the metabolism, pharmacokinetics, and toxicological profile of Itraconazole-related substances.

Basic Information

Product Name	Itraconazole Impurity 26
CAS No.	89848-15-7
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.63 g/mol
Synonyms	Itraconazole Related Compound 26; 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-3H-1,2,4-triazol-3-one; Itraconazole EP Impurity G; Itraconazole USP Impurity 26; Itraconazole Process Impurity; (2R*,4S*)-rel-1-(Butylsulfonyl)-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]-4,5-dihydro-1H-1,2,4-triazol-5-one (isomeric form)
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with pharmaceutical reference standard requirements. Each batch is characterized using advanced analytical techniques, including HPLC, LC-MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical data. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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