Description

Miconazole Impurity CAS NO 909277-71-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Miconazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• As a Certified Reference Standard (CRS) for the identification and quantification of impurities in Miconazole API and finished drug products.
• For analytical method development and validation in HPLC, UPLC, and GC analyses within quality control laboratories.
• In pharmaceutical research and development for stability studies and degradation pathway elucidation.
• As a critical component in regulatory compliance and documentation for submissions to agencies like the FDA, EMA, and PMDA.
• For use in pharmacopoeial testing to meet the specifications of USP, EP, BP, or other international pharmacopoeias.
• In academic and institutional research focusing on antifungal agents and their metabolite profiles.

Basic Information

Product Name	Miconazole Impurity
CAS No.	909277-71-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Miconazole Related Compound; Miconazole Impurity Standard; Miconazole Specified Impurity; Miconazole Process Impurity; Miconazole Degradant; Miconazole Nitrate Impurity; 1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1H-imidazole Impurity
EINECS	Contact for details

Quality Control

Every batch of our Miconazole Impurity is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity and structural confirmation. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting identity, purity, and impurity profile. Our quality commitment ensures the material is suitable for its intended use in regulated pharmaceutical analysis.

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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider using desiccants.

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)	Meets acceptance criteria
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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