Description

Fluconazole Impurity 10 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antifungal active pharmaceutical ingredient (API) Fluconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• As a certified reference standard for the quantitative and qualitative analysis of Fluconazole API and related drug products.
• For pharmaceutical impurity profiling and method validation in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• In quality control (QC) laboratories to monitor and control impurity levels during Fluconazole manufacturing processes.
• For research and development (R&D) studies focusing on the degradation pathways and stability of Fluconazole.
• As a critical component in regulatory submissions (e.g., DMF, CMC sections) to demonstrate comprehensive impurity control.
• Used in academic and institutional research investigating antifungal agents and their related substances.

Basic Information

Product Name	Fluconazole Impurity 10
CAS No.	1174406-04-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluconazole Related Compound; Fluconazole Impurity; Fluconazole Process Impurity; 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol Impurity; Fluconazole Specified Impurity; Pharmaceutical Reference Standard; Analytical Standard
EINECS	Contact for details

Quality Control

Every batch of Fluconazole Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, impurities, and other critical parameters.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term stability, consider storage under inert conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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