Description

Posaconazole Impurity 17 is a designated chemical reference standard used in the analytical profiling and quality control of the antifungal pharmaceutical, Posaconazole. This impurity is critical for ensuring the purity, safety, and efficacy of the drug substance and its formulations through rigorous chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on method development, validation, and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Posaconazole Impurity 17 in drug substance and drug product.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods according to ICH Q2(R1) requirements.
• Stability Studies & Forced Degradation: Used to monitor the formation of this specific impurity during long-term, accelerated, and stress testing of Posaconazole to establish shelf-life and storage conditions.
• Quality Control & Batch Release: Essential for routine QA/QC testing to ensure every batch of Posaconazole API and finished product meets stringent purity specifications.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data for drug approval and lifecycle management.
• Pharmacopoeial Testing: Used in testing to comply with monograph specifications in pharmacopoeias such as USP, EP, or BP where applicable.

Basic Information

Product Name	Posaconazole Impurity 17
CAS No.	171228-51-6
Molecular Formula	C37H42F2N8O4
Molecular Weight	700.78 g/mol
Synonyms	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 17; Posaconazole Related Compound 17; Noxafil Impurity 17; (3R,5R)-5-(2,4-Difluorophenyl)-5-[(1H-1,2,4-triazol-1-yl)methyl]-3-[[4-[4-[4-[2-[(1S)-1-methylpropyl]-3-oxo-1,2,4-triazol-4-yl]phenyl]piperazin-1-yl]phenoxy]methyl]oxolane
EINECS	Contact for details

Quality Control

Our Posaconazole Impurity 17 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes data on assay, related substances, and residual solvents, supporting its use as a high-purity reference standard for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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