Description

Rac 8-Hydroxy Efavirenz CAS NO 205754-33-2 is a key chiral intermediate and metabolite of the non-nucleoside reverse transcriptase inhibitor Efavirenz. This compound is of significant importance in pharmaceutical research and development, particularly for the synthesis and impurity profiling of antiviral drugs. It is primarily needed by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in the development, quality control, and metabolic studies of HIV therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification and quantification of Efavirenz and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Metabolite Studies: Used in in vitro and in vivo pharmacokinetic and pharmacodynamic research to study the metabolic pathways and biological activity of Efavirenz.
• Process Impurity Synthesis: Employed in the synthesis and isolation of specific process-related impurities and degradants for method development and validation in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development: Essential for developing and validating robust HPLC, UPLC, or LC-MS/MS methods for impurity profiling and assay determination of Efavirenz-based formulations.
• Chiral Resolution Studies: Acts as a racemic mixture for developing chiral separation techniques to isolate the individual enantiomers for further biological evaluation.
• Organic Synthesis Intermediate: Utilized as a building block in medicinal chemistry for the design and synthesis of novel Efavirenz analogs or derivatives with potential improved efficacy or reduced side effects.

Basic Information

Product Name	Rac 8-Hydroxy Efavirenz
CAS No.	205754-33-2
Molecular Formula	C14H9ClF3NO3
Molecular Weight	331.67 g/mol
Synonyms	(±)-8-Hydroxyefavirenz; 8-Hydroxy-Efavirenz (racemic); 8-OH-EFV; 4-Chloro-8-hydroxy-6-(trifluoromethyl)-2H-1-benzoxazin-2-one; 6-Chloro-4-(cyclopropylethynyl)-8-hydroxy-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one (racemate); Racemic 8-Hydroxy Efavirenz; Efavirenz 8-Hydroxy Metabolite (racemic); EFV-8-OH
EINECS	Contact for details

Quality Control

Our Rac 8-Hydroxy Efavirenz is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical research and reference standard applications. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to meet specific pharmacopeial or client requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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