Description

Clotrimazole Impurity 1 is a high-purity reference standard specifically identified and characterized for pharmaceutical analysis. This compound is critical for ensuring the quality, safety, and efficacy of the antifungal drug Clotrimazole by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories engaged in research, development, and regulatory compliance activities.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Clotrimazole Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure specificity and accuracy.
• Quality Control and Release Testing: Employed in routine QC testing to confirm that Clotrimazole batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Clotrimazole.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CEP) to demonstrate comprehensive impurity control and adherence to ICH guidelines (Q3A, Q3B).
• Research and Development: Utilized in synthetic chemistry R&D to study the formation and minimization of this impurity during the manufacturing process.

Basic Information

Product Name	Clotrimazole Impurity 1
CAS No.	98751-53-2
Molecular Formula	C22H17ClN2
Molecular Weight	344.84 g/mol
Synonyms	1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole; Clotrimazole Related Compound A; Clotrimazole EP Impurity A; Clotrimazole USP Related Compound A; 1-[(2-Chlorophenyl)diphenylmethyl]imidazole; (2-Chlorotrityl)imidazole; Clotrimazole Impurity A (EP); Clotrimazole Specified Impurity A
EINECS	Contact for details

Quality Control

Every batch of Clotrimazole Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, and other critical parameters.

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 light-sensitive and should be handled accordingly to maintain stability and purity.

Specification

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