Description

Clotrimazole Impurity A (Pharmeuropa): (2-Chlorophenyl)Diphenylmethanol is a high-purity reference standard critical for pharmaceutical quality control and analytical method development. This compound serves as a specified impurity in the pharmacopeial monograph for the antifungal drug Clotrimazole, making it essential for ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on API development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Clotrimazole Impurity A as per European Pharmacopoeia (Ph. Eur.) and other pharmacopeial monographs.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and GC methods for impurity analysis in Clotrimazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm that Clotrimazole API and drug products meet stringent impurity limits for regulatory filings and market release.
• Stability Studies: Used to monitor the formation of this specific degradation product in Clotrimazole formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research aimed at optimizing Clotrimazole manufacturing processes and minimizing related substances.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.

Basic Information

Product Name	Clotrimazole Impurity A (Pharmeuropa): (2-Chlorophenyl)Diphenylmethanol
CAS No.	66774-02-5
Molecular Formula	C19H15ClO
Molecular Weight	294.78 g/mol
Synonyms	(2-Chlorophenyl)diphenylmethanol; α-(2-Chlorophenyl)-α-phenylbenzenemethanol; 1-(2-Chlorophenyl)-1,1-diphenylmethanol; Clotrimazole Impurity A; Clotrimazole Related Compound A; Clotrimazole EP Impurity A; (2-Chlorophenyl)(phenyl)phenylmethanol; Benzenemethanol, α-(2-chlorophenyl)-α-phenyl-
EINECS	Contact for details

Quality Control

Every batch of our Clotrimazole Impurity A (Pharmeuropa) is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the exacting standards required for use as a pharmacopeial reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The container should be kept in a desiccator to protect this moisture-sensitive compound from humidity.

Specification

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

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