Description

Posaconazole Impurity 50 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 drug Posaconazole by serving as a known impurity marker. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Posaconazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Posaconazole batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products in Posaconazole formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity profiling, route scouting, and process chemistry research for Posaconazole synthesis and purification.

Basic Information

Product Name	Posaconazole Impurity 50
CAS No.	1902957-95-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 50; Posaconazole Impurity 50 (CAS 1902957-95-2); Posaconazole EP Impurity 50; Posaconazole USP Impurity 50; 4-[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-dihydro-2-[(S)-1-methylpropyl]-3H-1,2,4-triazol-3-one (IUPAC); UNII-Contact for details; Posaconazole Process Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 50 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity, ensuring compliance with relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled under inert conditions if specified to ensure long-term stability.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual Unknown Impurity: ≤ 1.0% Total Impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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