Description

Voriconazole Impurity 51 is a specified impurity and reference standard used in the analytical profiling of the antifungal pharmaceutical, Voriconazole. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Voriconazole Impurity 51 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, to monitor impurities.
• Quality Control (QC) Testing: Used in routine QC testing of Voriconazole API and formulations to ensure compliance with pharmacopeial limits for related substances (e.g., ICH Q3A/B).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity profiles over time and under various stress conditions.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports R&D efforts in process chemistry to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Voriconazole Impurity 51
CAS No.	83603-04-7
Molecular Formula	C16H14F3N5O
Molecular Weight	349.31 g/mol
Synonyms	Voriconazole Related Compound 51; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; UK-109496 Impurity 51; 4-Pyrimidinol, 5-fluoro-4-(1-(2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)-1-hydroxybutyl)-; Voriconazole EP Impurity G; Voriconazole USP Impurity 51
EINECS	Contact for details

Quality Control

Our Voriconazole Impurity 51 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided. We support compliance with ICH guidelines and major pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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