Description

Entecavir Hydrate CAS NO 209216-23-9 is a potent antiviral nucleoside analogue used as an active pharmaceutical ingredient (API). It is a critical component in the formulation of first-line oral medications for the chronic treatment of hepatitis B virus (HBV) infection. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing and producing effective antiviral therapies.

Application

• Primary Active Pharmaceutical Ingredient (API) in oral antiviral tablets for chronic hepatitis B treatment.
• Reference Standard for analytical method development and quality control in pharmaceutical laboratories.
• Research Chemical for studying antiviral mechanisms, resistance profiles, and next-generation HBV therapeutics.
• Formulation Development for creating generic and novel drug delivery systems (e.g., fixed-dose combinations).
• GMP Manufacturing for the commercial-scale production of finished dosage forms under strict regulatory guidelines.

Basic Information

Product Name	Entecavir Hydrate
CAS No.	209216-23-9
Molecular Formula	C12H15N5O3 • xH2O
Molecular Weight	295.29 (Anhydrous basis)
Synonyms	Entecavir Monohydrate; BMS-200475; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one Monohydrate; SQ-34676; NSC-722041; Entecavir (anhydrous) CAS 142217-69-4 (related)
EINECS	Contact for details

Quality Control

Our Entecavir Hydrate is manufactured and tested to meet the stringent requirements for pharmaceutical active ingredients. Quality is assured through a comprehensive analytical program that typically includes identification, assay, impurity profiling (including related substances and residual solvents), and tests for water content. We support compliance with major pharmacopoeial standards, and a Certificate of Analysis (COA) is provided with each batch to guarantee purity, identity, and strength.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 6.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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