Description

Posaconazole (Hydrate) CAS NO 1198769-38-8 is a potent triazole antifungal agent, widely recognized for its broad-spectrum activity against a variety of invasive fungal pathogens. Its primary value lies in its critical role as an active pharmaceutical ingredient (API) in the formulation of life-saving antifungal medications. This compound is essential for pharmaceutical manufacturers and research institutions focused on developing and producing treatments for severe systemic fungal infections, particularly in immunocompromised patients.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of oral suspensions, delayed-release tablets, and intravenous formulations for the prevention and treatment of invasive aspergillosis and candidiasis.
• Antifungal Drug Development: Key reference standard and building block in R&D for novel antifungal agents and combination therapies.
• Clinical Research: Used as a standard in pharmacokinetic, pharmacodynamic, and bioequivalence studies.
• Reference Standard: Serves as a high-purity chemical standard for quality control and analytical method development in pharmaceutical laboratories.
• Veterinary Medicine: Investigated for use in treating serious fungal infections in animals.

Basic Information

Product Name	Posaconazole (Hydrate)
CAS No.	1198769-38-8
Molecular Formula	C37H42F2N8O4 • xH2O
Molecular Weight	700.78 g/mol (anhydrous basis)
Synonyms	Posaconazole Hydrate; Posaconazole Monohydrate; SCH 56592; Noxafil; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[4-(2R,3R)-2-(2,4-difluorophenyl)-3-{4-[4-(2S,3S)-2-(2,4-difluorophenyl)-3-methyl-1,2,4-triazol-1-yl]butyl}morpholin-4-yl]phenyl}-1,2,4-triazol-1-yl)butyl-1,2,4-triazol-1-yl)butan-2-ol Hydrate
EINECS	Contact for details

Quality Control

Our Posaconazole (Hydrate) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, detailing results from tests such as HPLC assay, chiral purity, related substances, residual solvents, and water content (KF).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 5.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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