Description

Emtricitabine-13C,15N2 is a stable isotope-labeled analog of the nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine, specifically enriched with carbon-13 and nitrogen-15. This compound is an essential internal standard for the precise and accurate quantification of emtricitabine 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 academic institutions engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research to ensure data integrity and regulatory compliance.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the LC-MS/MS quantification of emtricitabine in plasma, serum, and other biological fluids for pharmacokinetic (PK) and toxicokinetic (TK) studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in mass spectrometry-based assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of emtricitabine.
• Clinical Research: Enables accurate therapeutic drug monitoring (TDM) and bioequivalence assessment for generic drug development of emtricitabine-containing formulations.
• Forensic and Anti-Doping Analysis: Provides a reliable reference for detecting and confirming the presence of emtricitabine in forensic toxicology and sports doping control laboratories.
• Method Development and Validation: Essential for developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Stable Isotope Tracer Studies: Can be utilized in specialized metabolic flux studies to trace biochemical pathways in research settings.

Basic Information

Product Name	Emtricitabine-13C,15N2
CAS No.	1217820-69-3
Molecular Formula	C813CH12FN315N2O3S
Molecular Weight	Approx. 250.25 g/mol
Synonyms	4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one-13C,15N2; FTC-13C,15N2; (-)-FTC-13C,15N2; Coviracil-13C,15N2; BW 524W91-13C,15N2; 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine-13C,15N2; Emtriva-13C,15N2
EINECS	Contact for details

Quality Control

Our Emtricitabine-13C,15N2 is manufactured under strict quality control protocols to ensure the highest isotopic and chemical purity required for sensitive mass spectrometry applications. Each batch is characterized by advanced spectroscopic and chromatographic methods, including NMR, HPLC, and MS, to confirm identity, isotopic enrichment, and purity. Certificates of Analysis (COA) detailing batch-specific data are provided and can be tailored to meet specific customer or regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99 atom % 13C; ≥ 99 atom % 15N
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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