Description

trans-Itraconazole CAS NO 252964-65-1 is a high-purity stereoisomer of the broad-spectrum triazole antifungal agent, itraconazole. This specific isomer is of significant interest in pharmaceutical research and development for its distinct biological profile and potential for creating advanced therapeutic formulations. It serves as a critical intermediate and reference standard for manufacturers and R&D laboratories focused on antifungal drug discovery, process optimization, and analytical method development. The compound is essential for ensuring product quality and advancing studies in medicinal chemistry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification, assay, and impurity profiling of itraconazole in quality control laboratories.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a key chiral building block in the synthetic pathway for manufacturing itraconazole and related triazole antifungal APIs.
• Medicinal Chemistry Research: Employed in structure-activity relationship (SAR) studies to develop new antifungal agents with improved efficacy and safety profiles.
• Analytical Method Development: Crucial for developing and validating chromatographic methods (e.g., HPLC, UPLC) to separate and quantify itraconazole isomers.
• Formulation Development: Used in pre-formulation studies to understand the physicochemical properties of the trans-isomer for advanced drug delivery systems.
• Regulatory Compliance & Documentation: Supports regulatory filings by providing definitive characterization data for drug substance specifications.

Basic Information

Product Name	trans-Itraconazole
CAS No.	252964-65-1
Molecular Formula	C35H38Cl2N8O4
Molecular Weight	705.64 g/mol
Synonyms	(2R,4S)-rel-1-(Butylcarbamoyl)-4-[4-[4-[4-[[(2R,4S)-rel-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; trans-Itraconazole; (2R,4S,2'R,4'S)-Itraconazole; Itraconazole trans-Diastereomer; cis-trans-Itraconazole (trans form)
EINECS	Contact for details

Quality Control

Our trans-Itraconazole is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) detailing results for assay, related substances, chiral purity, and residual solvents are provided with every shipment. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). 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
Assay (HPLC)	≥ 98.0%
Chiral Purity (HPLC)	≥ 99.0% (trans-isomer)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%

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