Description

Fluconazole Ep Impurity I is a designated impurity reference standard used in the pharmaceutical quality control process. This compound is critical for ensuring the purity, safety, and efficacy of the antifungal drug Fluconazole by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Fluconazole Ep Impurity I in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profile data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to monitor impurity levels in Fluconazole formulations under various stress conditions to determine shelf life and storage requirements.
• Pharmacopoeial Testing: Used to comply with monographs in the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international pharmacopoeias that specify impurity limits.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Fluconazole Ep Impurity I
CAS No.	150168-54-0
Molecular Formula	C13H12F2N6O
Molecular Weight	306.27 g/mol
Synonyms	2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol; Fluconazole Impurity I (EP); Fluconazole Related Compound I; 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-(2,4-difluorophenyl)-2-propanol; α-(2,4-Difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, GC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is provided, detailing the results against stringent in-house specifications. Our quality commitment aligns with the standards expected for pharmaceutical 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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