Description

Miconazole Ep Impurity I CAS NO 24169-00-4 is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of the antifungal drug Miconazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used in research and development, method validation, and as a certified standard for impurity profiling in accordance with European Pharmacopoeia (EP) and other international guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Miconazole Nitrate and related drug substances.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate HPLC, UPLC, and GC methods for accurate impurity quantification.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity control.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in drug products under various storage conditions.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthesis pathways to minimize the formation of this impurity.
• Pharmacopoeial Testing: Directly applicable for testing as per European Pharmacopoeia (EP) and other pharmacopoeial monographs for Miconazole.

Basic Information

Product Name	Miconazole Ep Impurity I
CAS No.	24169-00-4
Molecular Formula	C18H14Cl4N2O
Molecular Weight	416.13 g/mol
Synonyms	1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole; Miconazole Impurity I (EP); Miconazole Related Compound I; Miconazole Nitrate Impurity I; 1H-Imidazole, 1-[2-[(2,4-dichlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-; Miconazole EP Impurity A; Miconazole Nitrate EP Impurity I
EINECS	Contact for details

Quality Control

Every batch of Miconazole Ep Impurity I 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 pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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
Water Content (KF)	≤ 1.0% w/w

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