Description

Posaconazole Impurity 7 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Posaconazole active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH guidelines.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this specific impurity during drug stability testing and forced degradation studies.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting specification limits in the quality control laboratories of API and formulation manufacturers.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 7
CAS No.	2180759-84-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 7; Posaconazole EP Impurity G; Posaconazole USP Impurity; Posaconazole Process Impurity; SCH 56592 Impurity; 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-dihydropyridazin-3-one (Posaconazole Impurity); (3R,5R)-5-(2,4-Difluorophenyl)-5-[(1H-1,2,4-triazol-1-yl)methyl]-3-{[4'-(3-oxo-1,2-dihydropyridazin-4-yl)-4-biphenylyl]oxy}methyl-2-tetrahydrofuranyl methanol impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 7 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance. The material is suitable for use under current Good Manufacturing Practice (cGMP) guidelines.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

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

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