Description

Clotrimazole Impurity B is a high-purity chemical reference standard, specifically identified as a known impurity of the antifungal pharmaceutical agent Clotrimazole. This compound is critical for pharmaceutical research, development, and quality control processes, enabling precise analytical method validation and ensuring drug product purity and safety. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Clotrimazole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Used to establish specificity, accuracy, and detection limits for chromatographic assays in compliance with ICH Q2(R1) guidelines.
• Quality Control & Stability Studies: Serves as a system suitability and calibration standard in routine QC testing and forced degradation studies to monitor impurity profiles.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Pharmacopoeial Testing: Supports testing procedures aligned with USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs for Clotrimazole.
• Academic & Industrial Research: Utilized in metabolic pathway studies and impurity synthesis research within academic and industrial R&D settings.

Basic Information

Product Name	Clotrimazole Impurity B
CAS No.	27023-21-8
Molecular Formula	C22H17ClN2
Molecular Weight	344.84 g/mol
Synonyms	1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole; 1-[(2-Chlorophenyl)diphenylmethyl]imidazole; Clotrimazole Impurity 2; Clotrimazole Related Compound B; (2-Chlorophenyl)diphenylmethylimidazole; 1-[(2-Chlorophenyl)(phenyl)methyl]-1H-imidazole (isomeric form); Clotrimazole EP Impurity B
EINECS	Contact for details

Quality Control

Our Clotrimazole Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and IR for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines. The material is suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Total impurities ≤ 2.0% Any individual unknown 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.