Description

Miconazole Ep Impurity G 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 by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes. The availability of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Miconazole API (Active Pharmaceutical Ingredient).
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for Miconazole-based drug products.
• Essential for stability studies and degradation pathway profiling of antifungal formulations.
• Used in quality control laboratories to ensure batch-to-batch consistency and compliance with EP (European Pharmacopoeia), USP (United States Pharmacopeia), and ICH guidelines.
• Serves as a research tool in pharmaceutical R&D for studying the metabolism and pharmacokinetics of Miconazole.
• Supports regulatory submissions by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.

Basic Information

Product Name	Miconazole Ep Impurity G
CAS No.	909277-72-1
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole; Miconazole Impurity G; Miconazole Related Compound G; Miconazole EP Impurity G; (RS)-1-[2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl]imidazole; Miconazole Nitrate Impurity G
EINECS	Contact for details

Quality Control

Every batch of Miconazole Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs. Comprehensive characterization is performed using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity, purity, and strength. Certificates of Analysis (COA) detailing all test results and specifications are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions 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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.