Description

Fluconazole Impurity CAS NO 1609495-95-5 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 an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity supports robust quality control protocols and facilitates compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Fluconazole drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Stability Studies: Employed to monitor the formation of degradation products in Fluconazole formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) and Quality Assurance (QA): Acts as a system suitability standard and for routine batch testing in pharmaceutical QC laboratories to ensure product purity.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identity and supporting the establishment of specification limits.
• Research and Development: Utilized in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes for the Fluconazole API.

Basic Information

Product Name	Fluconazole Impurity
CAS No.	1609495-95-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluconazole Related Compound; Fluconazole Specified Impurity; Fluconazole Process Impurity; Fluconazole Degradant; (2R,3S)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (enantiomer); Fluconazole Isomer; Fluconazole EP Impurity; Fluconazole USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluconazole Impurity CAS 1609495-95-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines). A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and related substances is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The material should be kept under inert conditions if specified. For long-term storage, consider storing at 2-8°C. Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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