Description

8-(tert-Butyldimethylsilyloxy) 8-Hydroxy Efavirenz-D4 is a deuterated, silyl-protected derivative of the antiretroviral drug Efavirenz, serving as a critical stable isotope-labeled intermediate. This compound matters for its essential role in the synthesis and analytical quantification of Efavirenz and its metabolites, enabling precise pharmacokinetic and metabolic studies. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical reference standard manufacturers focused on developing and validating assays for HIV therapeutics.

Application

• Pharmaceutical Reference Standard: Used as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) for the accurate quantification of Efavirenz in biological matrices.
• Metabolite Research: Serves as a key synthetic precursor or analog for investigating the metabolic pathways and pharmacokinetics of Efavirenz.
• Deuterated Drug Synthesis: Acts as a high-purity intermediate in the preparation of deuterium-labeled active pharmaceutical ingredients (APIs) for clinical tracer studies.
• Analytical Method Development: Critical for developing and validating robust bioanalytical methods in compliance with FDA and ICH guidelines.
• Quality Control & Assurance: Employed in pharmaceutical quality control labs to ensure the specificity and accuracy of assays for Efavirenz-based drug products.

Basic Information

Product Name	8-(tert-Butyldimethylsilyloxy) 8-Hydroxy Efavirenz-D4
CAS No.	1185072-51-8
Molecular Formula	C16H15D4F3NO3Si
Molecular Weight	358.42 g/mol
Synonyms	8-[(1,1-Dimethylethyl)dimethylsilyl]oxy-5,6-dihydro-6-(trifluoromethyl)-8H,10H-d4-2-oxo-4H,8H-benzo[1,2-b:3,4-b']dipyran-3-carbonitrile; Efavirenz D4 TBDMS Ether; Efavirenz-d4 tert-Butyldimethylsilyl Ether; 8-O-(tert-Butyldimethylsilyl)efavirenz-d4; Deuterated Efavirenz TBDMS Derivative; 8-TBDMS-8-hydroxy Efavirenz-d4; Stable Isotope Labeled Efavirenz Intermediate
EINECS	Contact for details

Quality Control

Our 8-(tert-Butyldimethylsilyloxy) 8-Hydroxy Efavirenz-D4 is manufactured under strict quality systems to ensure high chemical and isotopic purity suitable for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results from NMR, HPLC, and LC-MS analyses. We ensure compliance with relevant standards for reference materials, and custom synthesis to specific purity or isotopic enrichment levels is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (LC-MS)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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