Description

Efavirenz Related Compound B (15 Mg) ((S,E)-6-Chloro-4-(2-Cyclopropylvinyl)-4-(Trifluoromethyl)-2H-3,1-Benzoxazin-2-One) is a high-purity reference standard critical for analytical and research purposes. This compound serves as a key impurity marker for the antiretroviral drug Efavirenz, ensuring the accuracy and reliability of pharmaceutical quality control processes. It is essential for laboratories in the pharmaceutical and biotechnology sectors requiring precise impurity profiling, method validation, and stability studies. The availability of this well-characterized standard is fundamental for maintaining compliance with stringent global regulatory requirements for drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling and Identification: 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, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of related substances in Efavirenz formulations.
• Quality Control and Batch Release Testing: An essential component in the routine QC testing of Efavirenz to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in metabolic studies, synthesis pathway research, and the development of generic versions of Efavirenz.

Basic Information

Product Name	Efavirenz Related Compound B (15 Mg) ((S,E)-6-Chloro-4-(2-Cyclopropylvinyl)-4-(Trifluoromethyl)-2H-3,1-Benzoxazin-2-One)
CAS No.	440124-96-9
Molecular Formula	C14H9ClF3NO2
Molecular Weight	315.67 g/mol
Synonyms	(S,E)-6-Chloro-4-(2-cyclopropylvinyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one; Efavirenz Impurity B; Efavirenz Related Substance B; (S,E)-6-Chloro-4-(2-cyclopropylvinyl)-4-(trifluoromethyl)-3,1-benzoxazin-2(4H)-one; UNII-8R3S6E9C3Q; 8R3S6E9C3Q; Benzoxazin-2-one, 6-chloro-4-(2-cyclopropylvinyl)-4-(trifluoromethyl)-, (4S)-; Efavirenz EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Efavirenz Related Compound B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results. Our quality commitment aligns with the expectations of cGMP and relevant pharmacopeial guidelines for reference standards.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (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%
Assay (on dried basis)	98.0% - 102.0%

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