Description

Voriconazole Impurity 16 is a designated impurity standard used in the analytical profiling and quality control of the antifungal pharmaceutical, Voriconazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Voriconazole active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Critical for developing, optimizing, and validating high-performance liquid chromatography (HPLC) and related analytical methods to meet ICH Q3A/B guidelines.
• Quality Control & Assurance: Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with strict pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Voriconazole formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes for Voriconazole.

Basic Information

Item	Details
Product Name	Voriconazole Impurity 16
CAS No.	1157981-64-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Voriconazole Related Compound 16; Voriconazole EP Impurity J; Voriconazole USP Impurity 16; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Impurity; Voriconazole Degradation Product; Voriconazole Process Impurity; Antifungal Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Voriconazole Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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) and light-sensitive; therefore, containers must be kept tightly sealed and stored in a desiccated environment away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.