Description

Miconazole Ep Impurity F CAS NO 47447-55-2 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antifungal drug Miconazole. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical industry for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Miconazole and its related substances.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity during drug substance and drug product testing to meet pharmacopeial requirements (EP, USP).
• Method Development & Validation: Serves as a critical component in developing and validating robust analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the active pharmaceutical ingredient (API).
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Used to track the formation of degradation impurities in Miconazole formulations under various stress conditions.

Basic Information

Product Name	Miconazole Ep Impurity F
CAS No.	47447-55-2
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole; Miconazole Impurity F; Miconazole Related Compound F; Miconazole EP Impurity F; 1H-Imidazole, 1-[2-[(2,4-dichlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-; UNII-0Q9K5N8V4F
EINECS	Contact for details

Quality Control

Our Miconazole EP Impurity F is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR), to ensure it meets the stringent standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product 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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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