Description

Fluconazole Impurity 1 CAS NO 173837-65-5 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the antifungal drug Fluconazole. It is primarily required by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs for method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fluconazole Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submission & Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control of the manufacturing process.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Research & Development: Used in synthetic chemistry and pharmacokinetic research to study the metabolism and degradation pathways of Fluconazole.

Basic Information

Product Name	Fluconazole Impurity 1
CAS No.	173837-65-5
Molecular Formula	C13H12F2N6O
Molecular Weight	306.27 g/mol
Synonyms	Fluconazole Related Compound A; Fluconazole EP Impurity A; Fluconazole USP Related Compound A; 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol; α-(2,4-Difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol; Diflucan Impurity A
EINECS	Contact for details

Quality Control

Every batch of Fluconazole Impurity 1 (CAS 173837-65-5) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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