Description

Butoconazole Impurity CAS NO 1850278-18-0 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 the active pharmaceutical ingredient (API) butoconazole nitrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in butoconazole nitrate API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods (e.g., HPLC, UPLC) for quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in butoconazole formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways of butoconazole and related compounds.
• Quality Control Testing: Acts as a system suitability standard and a comparator in the routine QC release testing of butoconazole API batches.

Basic Information

Product Name	Butoconazole Impurity
CAS No.	1850278-18-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Butoconazole Related Compound; Butoconazole Nitrate Impurity; Butoconazole Specified Impurity; 1-[4-(4-Chlorophenyl)-2-[(2,6-dichlorophenyl)thio]butyl]-1H-imidazole Impurity; (RS)-1-(4-(4-Chlorophenyl)-2-((2,6-dichlorophenyl)thio)butyl)-1H-imidazole Impurity; Gynazole-1 Impurity; Femstat Impurity
EINECS	Contact for details

Quality Control

Our Butoconazole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines for impurity reference standards.

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 moisture.

Specification

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