Description

Miconazole Related Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Miconazole, an important antifungal medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Miconazole API and its finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for stability studies and specification setting.
• Research & Development: Utilized in R&D laboratories to study the degradation pathways and stability profile of Miconazole.
• Pharmacopoeial Testing: Employed to verify compliance with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for related substances.

Basic Information

Product Name	Miconazole Related Impurity 1
CAS No.	911805-54-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Miconazole Impurity 1; Miconazole EP Impurity C; Miconazole Related Compound A; 1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole; Miconazole Nitrate Impurity 1
EINECS	Contact for details

Quality Control

Our Miconazole Related Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%

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