Description

Miconazole Impurity G(Ep) is a high-purity chemical reference standard, specifically identified as an impurity and epimer of the antifungal agent Miconazole. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the quality, safety, and efficacy of Miconazole-based drug substances and products. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specified impurities in Miconazole API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of degradation products and establish shelf-life specifications.
• Quality Control & Release Testing: Essential for routine batch analysis in QC laboratories to ensure drug substance and product compliance with pharmacopoeial standards (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate comprehensive impurity control strategies.
• Research on Stereochemistry: Used in studies investigating the stereochemical aspects and isomerism of Miconazole and related azole antifungals.

Basic Information

Item	Details
Product Name	Miconazole Impurity G(Ep)
CAS No.	1370335-40-2
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole; Miconazole EP Impurity G; Miconazole Impurity G (EP); Miconazole Related Compound G; (R)-Miconazole; Miconazole Epimer; UNII-7S96C86Q8W
EINECS	Contact for details

Quality Control

Every batch of Miconazole Impurity G(Ep) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopoeial standards and ICH Q3A/B guidelines. 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). This material 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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