Description

Fluconazole Impurity 4 is a specified impurity and reference standard used in the analytical profiling of the antifungal active pharmaceutical ingredient (API) Fluconazole. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic purity testing. It is primarily required by pharmaceutical manufacturers, quality control 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 impurities in Fluconazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control the levels of specified impurities, ensuring product consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products in Fluconazole under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Fluconazole Impurity 4
CAS No.	168479-96-7
Molecular Formula	C13H12F2N6O
Molecular Weight	306.27 g/mol
Synonyms	Fluconazole Related Compound C; Fluconazole EP Impurity C; Fluconazole USP Related Compound C; 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol Impurity; 1H-1,2,4-Triazole, 1,1'-(2,4-difluorophenyl)methylene]bis-; 1,1'-[(2,4-Difluorophenyl)methylene]bis[1H-1,2,4-triazole]; Fluconazole Impurity C (EP); Fluconazole Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluconazole Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, chromatographic data, and storage conditions. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% 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.