Description

Fluconazole Impurity CAS NO 163921-61-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antifungal active pharmaceutical ingredient (API) Fluconazole. It serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards for drug substance and finished product quality.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fluconazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP, BP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files (DMFs) and stability reports.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Research & Development (R&D): Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Fluconazole.

Basic Information

Product Name	Fluconazole Impurity
CAS No.	163921-61-7
Molecular Formula	C13H12F2N6O
Molecular Weight	306.27 g/mol
Synonyms	Fluconazole Related Compound; Fluconazole Process Impurity; 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol; 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-; Diflucan Impurity; UK-49858 Impurity; α-(2,4-Difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol
EINECS	Contact for details

Quality Control

Our Fluconazole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with ICH guidelines and relevant pharmacopeial expectations. Comprehensive characterization is performed using advanced techniques including HPLC, GC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with specified standards.

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 must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert conditions where appropriate.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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