Description

Rac-8,14-Bis(tert-Butyldimethylsilyloxy) Efavirenz-D4 is a deuterated and silyl-protected derivative of the antiretroviral drug Efavirenz, serving as a critical stable isotope-labeled intermediate. This compound is essential for pharmaceutical research and development, particularly in the synthesis of isotopically labeled drug metabolites and reference standards for mass spectrometry. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories specializing in drug metabolism and pharmacokinetics (DMPK) studies.

Application

• Synthesis of Deuterated Reference Standards: A key precursor for creating stable isotope-labeled Efavirenz metabolites used as internal standards in LC-MS/MS analysis.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking and quantification of drug metabolites in biological matrices to understand absorption, distribution, metabolism, and excretion (ADME).
• Pharmaceutical Impurity Profiling: Used to synthesize labeled impurities and degradants for method development and validation in quality control laboratories.
• Bioanalytical Research: Supports the development of highly sensitive and specific quantitative assays for therapeutic drug monitoring and clinical studies.
• Process Chemistry Development: Acts as a specialized intermediate in the route scouting and optimization for novel antiviral drug candidates.
• Regulatory Submission Support: Provides essential materials for studies required by agencies like the FDA and EMA to demonstrate analytical method robustness.

Basic Information

Product Name	Rac-8,14-Bis(tert-Butyldimethylsilyloxy) Efavirenz-D4
CAS No.	1329840-70-1
Molecular Formula	C31H39D4F3NO3Si2
Molecular Weight	Contact for details
Synonyms	(8R,14R/S)-8,14-Bis[(tert-butyldimethylsilyl)oxy]-5-chloro-4-(cyclopropylethynyl)-1,4-dihydro-2H-3,1-benzoxazin-2-one-d4; Efavirenz-8,14-bis(TBDMS)-d4; 8,14-Bis-O-(tert-butyldimethylsilyl)efavirenz-d4; rac-Efavirenz 8,14-bis(TBS) ether-d4; Deuterated Efavirenz Bis-Silyl Ether; (±)-8,14-Bis(tert-butyldimethylsiloxy)efavirenz-d4
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. We provide comprehensive analytical data to support your research and regulatory needs. Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles are available upon request. Our quality system is designed to meet the stringent requirements of pharmaceutical R&D and analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C under an inert atmosphere. This material is moisture-sensitive and should be handled under dry conditions to prevent decomposition.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Enrichment (MS)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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