Description

Tioconazole Related Compound B is a high-purity chemical reference standard and a key intermediate in the synthesis and quality control of the antifungal agent Tioconazole. Its primary value lies in its critical role for pharmaceutical R&D and analytical laboratories requiring precise impurity profiling and method validation. This compound is essential for manufacturers and quality control units within the pharmaceutical and fine chemical industries to ensure product purity, regulatory compliance, and batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tioconazole API and finished drug products according to ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, GC, or other chromatographic methods for quality control laboratories.
• Chemical Synthesis Intermediate: Acts as a key building block or precursor in the research-scale and commercial synthesis of Tioconazole and its structural analogs.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files and CMC sections.
• Academic & Industrial Research: Utilized in universities and corporate R&D for studying the structure-activity relationships (SAR) of azole antifungal agents.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor and control impurity levels, ensuring final product safety and efficacy.

Basic Information

Product Name	Tioconazole Related Compound B
CAS No.	61675-62-5
Molecular Formula	C16H13Cl3N2OS
Molecular Weight	387.71 g/mol
Synonyms	1-[2-[(2-Chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole; Tioconazole Impurity B; Tioconazole EP Impurity B; Tioconazole Related Substance B; (RS)-1-[2-[(2-Chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole; UNII-9J8U3Q9I6C; Ticonazole Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Tioconazole Related Compound B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, NMR), to ensure compliance with stringent in-house specifications and relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.