Description

Clotrimazole Impurity A CAS NO 23593-71-7 is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity in the synthesis and purification of the antifungal drug Clotrimazole, enabling precise identification and quantification during method development and validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on ensuring drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used 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: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure Clotrimazole batches meet the strict purity specifications of pharmacopeias like USP, EP, and BP.
• Stability Studies: Used to track the formation of degradation products in Clotrimazole formulations under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings with agencies such as the FDA and EMA.
• Research & Development: Supports synthetic chemistry research aimed at optimizing Clotrimazole manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Clotrimazole Impurity A
CAS No.	23593-71-7
Molecular Formula	C22H17ClN2
Molecular Weight	344.84 g/mol
Synonyms	1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole; Clotrimazole Impurity 1; Clotrimazole Related Compound A; 1-[(2-Chlorophenyl)diphenylmethyl]imidazole; (2-Chlorotrityl)imidazole; Clotrimazole EP Impurity A; Clotrimazole USP Related Compound A
EINECS	Contact for details

Quality Control

Our Clotrimazole Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing the results for identity, purity, and related substances. We support compliance with ICH, USP, and EP guidelines 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 material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.