Description

Posaconazole Impurity 13 is a designated chemical reference standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API), Posaconazole. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in method development, validation, and as a system suitability component in chromatographic analyses for the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Posaconazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods for Posaconazole.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Posaconazole formulations.
• Research & Development: Used in pharmaceutical R&D to understand the degradation pathways and chemistry of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 13
CAS No.	357189-98-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 13; Posaconazole EP Impurity J; Posaconazole USP Impurity; SCH 56592 Impurity; 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 13 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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