Description

Fenticonazole Nitrate Impurity D (Ep) is a high-purity chemical reference standard, specifically identified as a known impurity of the antifungal agent Fenticonazole Nitrate. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily utilized by quality assurance laboratories, regulatory affairs departments, and R&D chemists working on antifungal drug development and compliance with pharmacopoeial monographs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Fenticonazole Nitrate Impurity D in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine testing of Fenticonazole Nitrate to ensure compliance with stringent pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in studies to understand the degradation pathways and impurity fate of Fenticonazole Nitrate.

Basic Information

Product Name	Fenticonazole Nitrate Impurity D (Ep)
CAS No.	1313397-05-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fenticonazole Nitrate Related Compound D; Fenticonazole EP Impurity D; Fenticonazole Nitrate Specified Impurity D; 1H-Imidazole, 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio)phenyl]methoxy]ethyl]-, nitrate; Fenticonazole Nitrate Process Impurity; Fenticonazole Nitrate Degradant; Fenticonazole Nitrate Unknown Impurity D (EP)
EINECS	Contact for details

Quality Control

Every batch of Fenticonazole Nitrate Impurity D (Ep) is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR), to ensure it meets the high standards required for a pharmaceutical reference material. 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0% w/w

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