Description

Fenticonazole Ep Impurity C is a designated impurity standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient, Fenticonazole Nitrate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial guidelines such as the European Pharmacopoeia (EP). It is primarily utilized as a certified reference material (CRM) for method development, validation, and routine batch testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a primary standard for the identification and quantification of Fenticonazole Ep Impurity C in Fenticonazole Nitrate drug substance and finished products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, including HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure drug substances and products meet the specified impurity limits as per EP, ICH, and other regulatory requirements.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.

Basic Information

Product Name	Fenticonazole Ep Impurity C
CAS No.	80676-29-5
Molecular Formula	C24H20Cl2N2OS
Molecular Weight	455.40 g/mol
Synonyms	1-[2-(2,4-Dichlorophenyl)-2-{[4-(phenylthio)phenyl]methoxy}ethyl]-1H-imidazole; Fenticonazole Impurity C; Fenticonazole Related Compound C; Fenticonazole EP Impurity C; (RS)-1-(2,4-Dichloro-β-[(p-phenylthio)benzyloxy]phenethyl)imidazole
EINECS	Contact for details

Quality Control

Every batch of Fenticonazole Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods (e.g., HPLC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. 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 controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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