Description

Entecavir-13C2,15N is a stable isotope-labeled analog of the antiviral drug Entecavir, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is essential for ensuring the accuracy and reliability of mass spectrometry-based analyses, particularly in pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and regulatory bodies requiring precise quantification of Entecavir in complex biological matrices.

Application

• Quantitative Bioanalysis: Serves as an internal standard in LC-MS/MS and GC-MS methods for the precise quantification of Entecavir in plasma, serum, and other biological fluids.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug concentration over time to determine absorption, distribution, metabolism, and excretion (ADME) profiles.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the biotransformation pathways of Entecavir.
• Clinical Trial Support: Critical for ensuring data integrity in bioanalytical assays conducted during clinical development phases.
• Regulatory Submissions: Supports method validation and provides traceable data for filings with agencies like the FDA and EMA.
• Quality Control in Manufacturing: Can be utilized in analytical methods for monitoring the active pharmaceutical ingredient (API) during production.

Basic Information

Product Name	Entecavir-13C2,15N
CAS No.	1329796-53-3
Molecular Formula	C12H1313C215N5O3
Molecular Weight	Approx. 280.27 g/mol
Synonyms	2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-6,9-dihydro-3H-purin-6-one-13C2,15N; BMS-200475-13C2,15N; Entecavir-d2-15N; Labeled Entecavir; Entecavir Internal Standard; Stable Isotope-Labeled Entecavir; 13C2,15N-Entecavir
EINECS	Contact for details

Quality Control

Our Entecavir-13C2,15N is manufactured under strict quality systems to ensure the highest isotopic and chemical purity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment, chemical purity, and identity confirmation via advanced spectroscopic techniques. We adhere to relevant guidelines for reference standards to ensure reliable and reproducible performance in your analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or CoA. The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 99 atom % 13C; ≥ 99 atom % 15N
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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