Description

Miconazole Ep Impurity C is a high-purity chemical reference standard, specifically identified as an impurity of the antifungal pharmaceutical agent Miconazole. This compound is critical for ensuring the quality, safety, and efficacy of Miconazole drug substances and finished products through rigorous analytical testing. It is an essential tool for pharmaceutical R&D and quality control laboratories engaged in method development, validation, and stability studies. Professionals in the pharmaceutical and analytical chemistry sectors rely on this standard for precise impurity profiling and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Miconazole Ep Impurity C in drug substances and products.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, or GC methods for impurity detection in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Critical for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels against specified limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Pharmacopeial Compliance: Supports testing to meet the specifications of the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international standards.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Miconazole Ep Impurity C
CAS No.	67358-54-7
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole; Miconazole Impurity C; Miconazole Related Compound C; Miconazole EP Impurity C; (RS)-1-[2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl]imidazole; Miconazole Nitrate Impurity C; Miconazole Nitrate Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Miconazole Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, GC) and spectroscopic methods (NMR, MS, IR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. We support compliance with cGMP, ISO, and relevant FDA/ICH guidelines for pharmaceutical impurities.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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