Description

Posaconazole Impurity 16 is a designated impurity standard used in the pharmaceutical development and quality control of the antifungal drug Posaconazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Posaconazole Active Pharmaceutical Ingredient (API).
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Posaconazole.
• Essential for conducting stability studies and establishing impurity profiles as per ICH guidelines.
• Used in quality control (QC) and quality assurance (QA) laboratories for routine batch analysis of Posaconazole.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data.
• Valuable for research and development into the degradation pathways and metabolism of Posaconazole.

Basic Information

Product Name	Posaconazole Impurity 16
CAS No.	213381-02-3
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	Posaconazole Related Compound 16; Posaconazole EP Impurity G; Posaconazole USP 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-dihydro-2-[(S)-1-methylpropyl]-3H-1,2,4-triazol-3-one; SCH 56592 Impurity; Noxafil Impurity
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 16 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch is characterized and qualified using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and chromatographic data, ensuring full traceability and compliance with current pharmacopeial expectations (USP/EP) and ICH Q3A/B 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 COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.