Description

Efavirenz D5 is a deuterated isotopologue of the non-nucleoside reverse transcriptase inhibitor Efavirenz, where five hydrogen atoms are replaced by deuterium. This compound is a critical stable isotope-labeled internal standard used in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development and quality control of antiretroviral therapies.

Application

• Bioanalytical Reference Standard: Serves as a deuterated internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Efavirenz in biological matrices like plasma, serum, and tissues.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Pharmaceutical Quality Control: Used in analytical method development and validation to ensure the specificity and accuracy of assays for active pharmaceutical ingredient (API) purity and stability testing.
• Clinical Research: Supports therapeutic drug monitoring (TDM) studies to optimize dosing regimens and assess patient adherence in HIV treatment programs.
• Metabolite Identification: Aids in the structural elucidation of Efavirenz metabolites by providing a mass spectrometric reference with a predictable mass shift.
• Regulatory Submissions: Provides the validated data required for regulatory filings with agencies such as the FDA and EMA, supporting New Drug Applications (NDAs).

Basic Information

Product Name	Efavirenz D5
CAS No.	1132642-95-5
Molecular Formula	C14H4D5ClF3NO2
Molecular Weight	319.71 g/mol (for C14H9ClF3NO2)
Synonyms	(S)-6-Chloro-4-(cyclopropylethynyl)-4-(trideuteriomethyl)-1,4-dihydro-2H-3,1-benzoxazin-2-one; Efavirenz-d5; 2H-3,1-Benzoxazin-2-one, 6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trideuteriomethyl)-, (4S)-; Deuterated Efavirenz; Efavirenz (pentadeutero); Sustiva-d5 (labeled analogue)
EINECS	Contact for details

Quality Control

Our Efavirenz D5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR and Mass Spectrometry for isotopic enrichment verification and HPLC for chemical and isotopic purity. We provide a comprehensive Certificate of Analysis (COA) detailing all specifications, ensuring the material meets the stringent requirements for use as a certified reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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