Description

Butoconazole Impurity CAS NO 98011-62-2 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antifungal active pharmaceutical ingredient (API), Butoconazole Nitrate. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in method development, validation, and stability studies to monitor and control the quality of the final drug substance and product.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Butoconazole Nitrate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to separate and analyze impurities.
• Stability Indicating Studies: Used to assess the degradation pathways and stability profile of Butoconazole formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: A critical component in the routine QC testing of pharmaceutical raw materials and finished products to meet pharmacopeial (USP, EP) specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for safety and quality assessments.
• Research & Development: Used in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during the API manufacturing process.

Basic Information

Product Name	Butoconazole Impurity
CAS No.	98011-62-2
Molecular Formula	C19H15Cl3N2OS
Molecular Weight	425.76 g/mol
Synonyms	1-[4-(4-Chlorophenyl)-2-[(2,6-dichlorophenyl)thio]butyl]-1H-imidazole; Butoconazole Related Compound; Butoconazole Nitrate Impurity; Butoconazole EP Impurity; Butoconazole USP Impurity; (±)-1-[4-(4-Chlorophenyl)-2-[(2,6-dichlorophenyl)thio]butyl]-1H-imidazole
EINECS	Contact for details

Quality Control

Every batch of Butoconazole Impurity (CAS 98011-62-2) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
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 impurity ≤ 0.5%
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.