Description

Posaconazole Impurity 93 is a designated chemical reference standard used in the analytical profiling and quality control of the antifungal drug Posaconazole. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs for method validation and compliance testing.

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 finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) or Ultra-Performance Liquid Chromatography (UPLC) methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to monitor batch-to-batch consistency and impurity profiles.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Posaconazole formulations under various stress conditions (e.g., heat, light, humidity).
• Research and Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Posaconazole Impurity 93
CAS No.	165115-82-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 93; Posaconazole Impurity C; Posaconazole EP Impurity C; 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; UNII-7G1J8432VZ
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 93 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification. We support compliance with ICH Q3A(R2), Q3B(R2), and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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