Description

Fluconazole Impurity [1, 3-Bis(1H-1, 2, 4-Triazole-1-Yl)Propan-2-One] 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, impurity profiling, and stability studies. Our product is supplied with comprehensive analytical data to support your quality control and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Fluconazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing characterized impurity material for stability and forced degradation studies.
• Research & Development (R&D): Used in synthetic chemistry research to study degradation pathways and the formation of process-related impurities.
• Pharmacopoeial Testing: Aids in compliance testing against pharmacopoeial monographs (USP, EP, BP) that specify impurity limits for Fluconazole.

Basic Information

Item	Detail
Product Name	Fluconazole Impurity [1, 3-Bis(1H-1, 2, 4-Triazole-1-Yl)Propan-2-One]
CAS No.	1449785-88-9
Molecular Formula	C7H8N6O
Molecular Weight	192.18 g/mol
Synonyms	1,3-Bis(1H-1,2,4-triazol-1-yl)propan-2-one; 1,3-Bis(1,2,4-triazol-1-yl)propan-2-one; Fluconazole Impurity 1; Fluconazole Related Compound A; 2-Propanone, 1,3-bis(1H-1,2,4-triazol-1-yl)-; UNII-4B5F8Y8Q3M; 4B5F8Y8Q3M
EINECS	Contact for details

Quality Control

Every batch of our Fluconazole Impurity standard is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical documentation, including a Certificate of Analysis (COA) detailing purity, identity, and impurity profiles as determined by validated methods (HPLC, NMR, MS). Our quality standards are designed to meet the rigorous requirements of pharmaceutical R&D and regulatory compliance. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive (store away from light).

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0% w/w

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