Description

Clotrimazole Ep Impurity G is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of antifungal drug products by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in the production and testing of Clotrimazole and its formulations.

Application

• Primary use as a pharmaceutical reference standard for impurity identification and quantification.
• Method development and validation for HPLC and GC analysis of Clotrimazole drug substances and products.
• Quality control testing to ensure compliance with pharmacopoeial standards (e.g., EP, USP, ICH guidelines).
• Stability studies and forced degradation studies to profile impurity formation.
• Research and development of new synthetic routes for Clotrimazole.
• Calibration of analytical instruments in quality control laboratories.

Basic Information

Product Name	Clotrimazole Ep Impurity G
CAS No.	289887-34-9
Molecular Formula	C22H17ClN2
Molecular Weight	344.84 g/mol
Synonyms	1-[(2-Chlorophenyl)(diphenyl)methyl]-1H-imidazole Impurity G; Clotrimazole Related Compound G; (2-Chlorophenyl)diphenylmethyl-1H-imidazole Impurity; Clotrimazole Impurity G (EP); Clotrimazole Specified Impurity G; 1-[(2-Chlorophenyl)diphenylmethyl]imidazole Impurity; Clotrimazole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Clotrimazole Ep Impurity G is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our products are characterized and qualified using advanced techniques including HPLC, GC-MS, and NMR to ensure identity, purity, and traceability. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3B(R2) guidelines for impurities in new drug substances.

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 dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white 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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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