Description

Voriconazole Ep Impurity E is a specified impurity and reference standard used in the pharmaceutical development and quality control of the antifungal drug Voriconazole. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Voriconazole API and finished drug products.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., EP, USP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Voriconazole Ep Impurity E
CAS No.	2287183-06-4
Molecular Formula	C16H14F3N5O
Molecular Weight	349.31 g/mol
Synonyms	(2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; Voriconazole Impurity E; Voriconazole Related Compound E; Voriconazole EP Impurity E; (2R,3S)-Voriconazole Impurity; UNII-6K8V8U66QJ
EINECS	Contact for details

Quality Control

Every batch of Voriconazole Ep Impurity E is manufactured and analyzed under strict quality management systems. It undergoes comprehensive testing to meet the stringent requirements for pharmaceutical reference standards, including identity confirmation, purity assessment by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) detailing all test results against relevant specifications is provided with each shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.