Description

Fenticonazole Impurity B Nitrate 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, Fenticonazole Nitrate. It is primarily required by pharmaceutical development and quality control laboratories for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Fenticonazole Impurity B in Fenticonazole Nitrate drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine batch release testing to ensure drug purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop improved purification processes for the API.

Basic Information

Product Name	Fenticonazole Impurity B Nitrate
CAS No.	80639-95-8
Molecular Formula	C24H20Cl2N6O3S
Molecular Weight	559.43 g/mol
Synonyms	1-[2-(2,4-Dichlorophenyl)-2-{[4-(phenylsulfanyl)phenyl]methoxy}ethyl]-1H-imidazole Nitrate; Fenticonazole Nitrate Impurity B; Fenticonazole Related Compound B; (RS)-1-[2,4-Dichloro-β-[(4-(phenylthio)benzyl)oxy]phenethyl]imidazole Nitrate; Fenticonazole EP Impurity B Nitrate; Fenticonazole USP Impurity B Nitrate
EINECS	Contact for details

Quality Control

Every batch of Fenticonazole Impurity B Nitrate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. 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 at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% 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.