Description

Fluconazole Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API) Fluconazole. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Fluconazole Impurity 5 in Fluconazole API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure API and drug product batches meet stringent pharmacopeial (USP, EP, ICH) impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand and minimize the formation of this impurity during the manufacturing process.

Basic Information

Product Name	Fluconazole Impurity 5
CAS No.	154534-83-5
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 E; Fluconazole Related Compound E; 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-(2,4-difluorophenyl)-2-propanol; UNII-6F8Q1N6W3H; 6F8Q1N6W3H; Fluconazole EP Impurity E; Fluconazole USP Related Compound E
EINECS	Contact for details

Quality Control

Our Fluconazole Impurity 5 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); ensure containers are sealed after 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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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