Description

(1S,3S,4R)-Entecavir CAS NO 1367369-79-6 is a high-purity enantiomer of the potent antiviral nucleoside analogue Entecavir. This specific stereoisomer is critical for ensuring the highest efficacy and safety profile in advanced pharmaceutical research and development. It is an essential reference standard and key starting material for scientists and manufacturers developing and producing next-generation antiviral therapies, particularly for the treatment of chronic hepatitis B virus (HBV) infection.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for analytical method development, validation, and quality control testing of antiviral drug products and active pharmaceutical ingredients (APIs).
• Active Pharmaceutical Ingredient (API) Synthesis: Used as a critical chiral intermediate or the final API in the manufacturing of enantiomerically pure Entecavir-based medications.
• Biomedical Research: Employed in preclinical and clinical studies to investigate the mechanism of action, pharmacokinetics, and pharmacodynamics of Entecavir.
• Process Development & Optimization: Utilized in scaling up synthetic routes and developing robust, GMP-compliant manufacturing processes for antiviral drugs.
• Regulatory Submissions: Provides essential data and material for regulatory filings (e.g., with FDA, EMA) to demonstrate drug identity, purity, and strength.

Basic Information

Product Name	(1S,3S,4R)-Entecavir
CAS No.	1367369-79-6
Molecular Formula	C12H15N5O3
Molecular Weight	277.28 g/mol
Synonyms	Entecavir (1S,3S,4R)-isomer; BMS-200475-05; (1S,3S,4R)-2-Amino-1,9-dihydro-9-[(1S,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one; SQ 34676; NSC 722041; Entecavir enantiomer; (-)-Entecavir
EINECS	Contact for details

Quality Control

Our (1S,3S,4R)-Entecavir is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC, to ensure enantiomeric purity and compliance with stringent pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and all critical specifications.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	≥98.5%
Enantiomeric Purity (Chiral HPLC)	≥99.0%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤1.0%

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