Description

Fluconazole Impurity C is a designated impurity standard used in the pharmaceutical development and quality control of the antifungal drug Fluconazole. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Fluconazole Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities during drug synthesis and formulation.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Fluconazole API and drug products meet stringent pharmacopoeial purity specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity profiling.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this impurity during Fluconazole manufacturing.

Basic Information

Product Name	Fluconazole Impurity C
CAS No.	514222-44-7
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 3; Fluconazole Related Compound C; 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-(2,4-difluorophenyl)-2-propanol; UNII-2R1G2A3P8S
EINECS	Contact for details

Quality Control

Our Fluconazole Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH and pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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 single 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.