Description

Fenticonazole Nitrate Impurity E (Ep) is a high-purity chemical reference standard, specifically identified as an impurity of the antifungal agent Fenticonazole Nitrate. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control of the active pharmaceutical ingredient. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and fine chemical industries who require definitive standards for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Fenticonazole Nitrate Impurity E in drug substance and drug product analysis.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure product purity and meet ICH guidelines.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Fenticonazole Nitrate formulations.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Fenticonazole Nitrate Impurity E (Ep)
CAS No.	1313397-06-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fenticonazole Impurity E; Fenticonazole Nitrate EP Impurity E; Fenticonazole Related Compound E; (2RS)-1-[2-(2,4-Dichlorophenyl)-2-{[4-(phenylsulfanyl)phenyl]methoxy}ethyl]-1H-imidazole Nitrate; 1H-Imidazole, 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio)phenyl]methoxy]ethyl]-, nitrate (1:1); Fenticonazole Nitrate Impurity E (EP)
EINECS	Contact for details

Quality Control

Every batch of Fenticonazole Nitrate Impurity E (Ep) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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