Description

Miconazole Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Miconazole by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on compliance and product development.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Miconazole API and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Miconazole.
• Essential for regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and control strategies as per ICH guidelines.
• Valuable for pharmacopoeial testing to comply with USP, EP, or other pharmacopoeia monographs for Miconazole.
• Utilized in academic and institutional research investigating the chemistry, metabolism, and synthesis of antifungal agents.

Basic Information

Product Name	Miconazole Impurity B
CAS No.	913837-72-6
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 B; Miconazole Related Compound B; Miconazole Impurity 2; (RS)-1-(2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl)imidazole
EINECS	Contact for details

Quality Control

Every batch of Miconazole Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC). Certificates of Analysis (COA) detailing batch-specific results are available upon request.

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 light-sensitive and should be handled to minimize prolonged exposure.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.