Description

Rac 8,14-Dihydroxy Efavirenz-D4 is a deuterated analog of the HIV-1 reverse transcriptase inhibitor efavirenz, specifically designed for use as a critical internal standard in analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative analyses in pharmaceutical research and quality control. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies involved in the development and manufacturing of antiretroviral drugs.

Application

• Internal Standard for LC-MS/MS: Serves as a stable, non-interfering reference compound for the precise quantification of efavirenz and its metabolites in biological matrices (plasma, serum) during pharmacokinetic and bioequivalence studies.
• Pharmaceutical Impurity Profiling: Used in method development and validation to identify and quantify process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Metabolite Studies: Aids in the identification and structural elucidation of hydroxylated metabolites of efavirenz in drug metabolism and pharmacokinetics (DMPK) research.
• Quality Assurance & Control: Critical for ensuring batch-to-batch consistency and compliance with regulatory specifications (e.g., ICH guidelines) in API manufacturing.
• Stability-Indicating Methods: Employed in the development of analytical methods to monitor the stability of efavirenz formulations under various stress conditions.
• Forensic and Anti-Counterfeiting Analysis: Supports the authentication and quality verification of pharmaceutical products in regulatory and forensic laboratories.

Basic Information

Product Name	Rac 8,14-Dihydroxy Efavirenz-D4
CAS No.	1189859-26-4
Molecular Formula	C14H5D4ClF3NO3
Molecular Weight	327.71 g/mol (for unlabeled form; adjusted for D4)
Synonyms	(±)-8,14-Dihydroxyefavirenz-d4; 8,14-Dihydroxy-D4-efavirenz; Efavirenz 8,14-diol-d4; 6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-8,14-dihydroxy-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one-d4; Deuterated 8,14-Dihydroxy Efavirenz; Rac-D4-8,14-Dihydroxy Efavirenz; Internal Standard for Efavirenz Analysis
EINECS	Contact for details

Quality Control

Every batch of Rac 8,14-Dihydroxy Efavirenz-D4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and isotopic enrichment. Our quality protocols are designed to meet the stringent requirements of analytical reference standard applications. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), isotopic purity (D-content), and structural confirmation (by NMR and MS) is provided with each shipment to support your regulatory and research documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (NMR)	Consistent with structure
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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