Description

Efavirenz 13C6 CAS NO 1261394-62-0 is a stable isotope-labeled analog of the non-nucleoside reverse transcriptase inhibitor Efavirenz, where six carbon atoms are replaced with the 13C isotope. This compound is an essential internal standard for the precise and accurate quantification of Efavirenz in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in bioanalytical method development, pharmacokinetic studies, and therapeutic drug monitoring for HIV treatment.

Application

• Bioanalytical Method Development: Serves as a critical internal standard for developing and validating robust LC-MS/MS methods for Efavirenz quantification.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration in plasma, serum, and tissues for clinical and preclinical research.
• Therapeutic Drug Monitoring (TDM): Used in clinical laboratories to ensure optimal dosing and efficacy of antiretroviral therapy in HIV patients.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in mass spectrometry-based studies.
• Drug Impurity and Degradation Product Analysis: Acts as a reference standard in stability-indicating assays to track purity and stability of the active pharmaceutical ingredient (API).
• Regulatory Compliance and Submission: Supports data packages for regulatory filings (e.g., FDA, EMA) requiring validated bioanalytical data.

Basic Information

Product Name	Efavirenz 13C6
CAS No.	1261394-62-0
Molecular Formula	C1413C6H9ClF3NO2
Molecular Weight	321.68 (for unlabeled); ~327.7 (for 13C6 labeled, exact mass varies)
Synonyms	Efavirenz-13C6; (4S)-6-Chloro-4-(2-cyclopropylethynyl)-4-(trifluoromethyl)-2,4-dihydro-1H-3,1-benzoxazin-2-one-13C6; EFV-13C6; Sustiva-13C6 (labeled analog); 13C6-Labeled Efavirenz; Isotopically Labeled Efavirenz; NNRTI Internal Standard-13C6
EINECS	Contact for details

Quality Control

Our Efavirenz 13C6 is manufactured under strict quality control protocols to ensure the highest isotopic and chemical purity for critical analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing isotopic enrichment (typically ≥99 atom % 13C), chemical purity (by HPLC), and confirmation of structure (by NMR and MS). We adhere to relevant industry standards for reference materials, and custom synthesis to meet specific purity or concentration requirements is available.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum confirms molecular ion and fragmentation pattern
Purity (HPLC)	≥98.0% (chemical purity)
Isotopic Purity	≥99 atom % 13C
Isotopic Enrichment	≥99% on six labeled positions
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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