Description

Fluconazole Impurity 11 is a designated chemical reference standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API), Fluconazole. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical component in the stability studies of Fluconazole-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Fluconazole API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that impurity levels are within ICH (International Council for Harmonisation) and pharmacopeial (USP, EP) specified limits.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Fluconazole.

Basic Information

Item	Details
Product Name	Fluconazole Impurity 11
CAS No.	206050-23-9
Molecular Formula	C13H12F2N6O
Molecular Weight	306.27 g/mol
Synonyms	Fluconazole Related Compound 11; Fluconazole EP Impurity J; Fluconazole USP Impurity 11; 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-, (αR)-; (R)-α-(2,4-Difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol; (R)-Fluconazole Impurity; Diflucan Impurity 11
EINECS	Contact for details

Quality Control

Our Fluconazole Impurity 11 is manufactured and handled under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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