Description

Efavirenz Related Compound C (20 Mg) (6-Chloro-2-Cyclopropyl-4-(Trifluoromethyl)Quinoline) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of Efavirenz, a key antiretroviral medication, by serving as a benchmark in analytical testing. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Efavirenz Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure API and drug product specifications are met.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to monitor the degradation pathways and stability profile of Efavirenz under various storage conditions.
• Research and Development: Facilitates chemical and metabolic studies related to Efavirenz, aiding in the understanding of its properties and behavior.

Basic Information

Product Name	Efavirenz Related Compound C (20 Mg) (6-Chloro-2-Cyclopropyl-4-(Trifluoromethyl)Quinoline)
CAS No.	391860-73-4
Molecular Formula	C₁₃H₉ClF₃N
Molecular Weight	271.67 g/mol
Synonyms	6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline; Efavirenz Impurity C; Efavirenz Related Substance C; EFV Related Compound C; 2-Cyclopropyl-6-chloro-4-(trifluoromethyl)quinoline; Quinoline, 6-chloro-2-cyclopropyl-4-(trifluoromethyl)-; EFV Impurity C
EINECS	Contact for details

Quality Control

Our Efavirenz Related Compound C is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by validated analytical methods (e.g., HPLC, NMR, MS). We are committed to supporting compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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