Description

Posaconazole Impurity 18 is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API), Posaconazole. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Posaconazole Impurity 18 in Posaconazole API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing to monitor impurity levels and ensure batches meet pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Employed as a marker to track the formation of this specific impurity during forced degradation and long-term stability studies of Posaconazole formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support the development of robust manufacturing processes for Posaconazole.

Basic Information

Item	Detail
Product Name	Posaconazole Impurity 18
CAS No.	213381-06-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Posaconazole Related Compound 18; Posaconazole EP Impurity G; Posaconazole USP Impurity 18; 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; Posaconazole Degradant; Posaconazole Process Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 18 is manufactured and handled 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. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 area.

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 with specification
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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