Description

Posaconazole Impurity 4 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 active pharmaceutical ingredient (API) Posaconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Posaconazole API and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control laboratories.
• Essential for stability studies and degradation pathway profiling of Posaconazole formulations.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications.
• Valuable for research and development of Posaconazole synthesis processes and impurity fate studies.
• Serves as a calibration standard in mass spectrometry and other advanced analytical techniques.

Basic Information

Product Name	Posaconazole Impurity 4
CAS No.	2125944-53-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 4; Posaconazole EP Impurity D; Posaconazole USP Impurity 4; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-{4-[4-(4-{[(3R,5R)-5-{[(1R,2S)-2-(2,4-Difluorophenyl)-2-hydroxy-1-methyl-3-(1H-1,2,4-triazol-1-yl)propyl]sulfanyl}methyl)-2,2-dimethyl-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]pentyl}-2,2-dimethyl-1,3-dioxolan-4-yl)methyl]-1,2,4-triazol-1-ium; UNII-7Q8K3F5B8T; Posaconazole Impurity D; Posaconazole Specified Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Posaconazole Impurity 4 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified criteria and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

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)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 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.