Category
Entecavir
CAS Number
Entecavir STD-142217-69-4;209216-23-9(Monohydrate Salt): IMP-A-1367369-78-5: IMP-C-2204369-23-1
Molecular Formula
Entecavir STD-C12H15N5O3: IMP-A-C12H15N5O3: IMP-C-C12H15N5O4
Molecular Weight
Entecavir STD-277.28: IMP-A-277.28: IMP-C-293.28
Synonym

Entecavir STD-2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1H-purin-6-one; 2-Amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-Purin-6-one; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1,9-dihydro-6H-purin- 6-one; Baraclude (USP)

Entecavir EP-Impurity-A-2-amino-9-[(1R,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1H-purin-6-one; 2-Amino-9-((1R,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1H-purin-6(9H)-one; 2-Amino-1,9-dihydro-9-[(1R,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one

Entecavir EP-Impurity-C-2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-1,7-dihydropurine-6,8-dione; 2-Amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-7,9-dihydro-1H-purine-6,8-dione; 2-Amino-8-hydroxy-9-((1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1H-purin-6(9H)-one; 8-Hydroxy Entecavir; 8-Hydroxy-9-[(1S ,3R ,4S )-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]guanine (USP)

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Entecavir is used as a reference standard in system suitability tests for chromatographic methods, such as HPLC, to ensure the analytical system is performing correctly. It helps assess parameters like retention time, peak shape, resolution, and reproducibility, confirming that the method meets Current Regulatory Standards (CRS) before analyzing actual samples. Its consistent and well-characterized behavior makes it a reliable compound for validating the performance of the chromatographic system.