Description

Posaconazole Impurity 25 is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API), Posaconazole. This compound is critical for ensuring the purity, safety, and efficacy of Posaconazole formulations by providing a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of antifungal medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Posaconazole Impurity 25 in Posaconazole API and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the manufacturing process.
• Quality Control (QC) Testing: Used in routine QC testing of Posaconazole batches to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity profiles over time.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Research and Development: Utilized in synthetic chemistry R&D to understand and control impurity formation pathways during Posaconazole synthesis.

Basic Information

Product Name	Posaconazole Impurity 25
CAS No.	1042398-26-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 25; Posaconazole EP Impurity 25; Posaconazole USP Impurity 25; Posaconazole Process Impurity 25; (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; UNII-7K6J8T8I4R
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 25 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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