Description

Posaconazole Impurity 50 is a designated reference standard used in the analytical profiling and quality control of the antifungal drug Posaconazole. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for Posaconazole API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Posaconazole Active Pharmaceutical Ingredient (API) and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish shelf life.
• Quality Control & Batch Release: A critical component in the routine QC testing of Posaconazole batches to ensure they meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Posaconazole, supporting formulation improvements.

Basic Information

Product Name	Posaconazole Impurity 50
CAS No.	1822329-44-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 50; Posaconazole Impurity 50 (EP); Posaconazole Specified Impurity 50; UNII-Contact for details; Posaconazole Process Impurity; Posaconazole Degradant; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[4-(4-{[(3R,5R)-5-(2,4-Difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-1,2,4-oxadiazol-3-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol (IUPAC-based); SCH 56592 Impurity 50
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 50 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia 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) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions if the container is opened repeatedly to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.