Description

Rac 8-Hydroxy Efavirenz CAS NO 205754-32-1 is a key chiral intermediate and metabolite of the non-nucleoside reverse transcriptase inhibitor Efavirenz. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel antiviral agents. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) for use in analytical reference standards and process chemistry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for analytical method development and validation in quality control laboratories.
• Metabolite Studies: Critical for in-vitro and in-vivo metabolism studies to understand the biotransformation pathways of Efavirenz.
• Process Impurity Profiling: Employed in the identification and quantification of related substances during the API manufacturing process to ensure purity.
• Pharmacokinetic Research: Serves as a standard in bioanalytical assays (e.g., LC-MS/MS) for quantifying drug and metabolite levels in biological matrices.
• Synthetic Intermediate: Utilized as a building block in the research-scale synthesis of Efavirenz analogs and derivatives for structure-activity relationship (SAR) studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) concerning drug impurity profiles and metabolic fate.

Basic Information

Product Name	Rac 8-Hydroxy Efavirenz
CAS No.	205754-32-1
Molecular Formula	C14H9ClF3NO3
Molecular Weight	331.67 g/mol
Synonyms	(±)-8-Hydroxyefavirenz; 8-Hydroxy-Efavirenz (racemic); 8-OH-EFV; 6-Chloro-4-(cyclopropylethynyl)-8-hydroxy-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one; 8-Hydroxy-DMP 266; Racemic 8-Hydroxy Efavirenz; 8-Hydroxy Sustiva metabolite
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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