Description

Miconazole Ep Impurity F CAS NO 27220-35-5 is a high-purity chemical reference standard, specifically identified as an impurity of the antifungal drug Miconazole. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification and quantification of related substances in active pharmaceutical ingredients (APIs). It is primarily utilized by analytical laboratories, R&D scientists, and quality assurance professionals in the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) for the identification and quantification of Miconazole-related impurities during method development and validation.
• Quality Control (QC) Testing: Serves as a critical standard in the routine QC testing of Miconazole Nitrate or Miconazole API batches to monitor impurity levels against pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Miconazole formulations to track the formation of this specific degradation product.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Analytical Method Development: Acts as a key component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation.
• Research and Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Miconazole.

Basic Information

Product Name	Miconazole Ep Impurity F
CAS No.	27220-35-5
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole; Miconazole Impurity F; Miconazole Related Compound F; Miconazole EP Impurity F; Miconazole Nitrate Impurity F; 1H-Imidazole, 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-; UNII-5V4B5Y3A0K
EINECS	Contact for details

Quality Control

Every batch of Miconazole EP Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards (EP/BP, USP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, residual solvents, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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. Handle and store in accordance with good laboratory practices.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5% w/w

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