|Place of Origin:||CHINA|
|Model Number:||Antibiotic Drugs API - 5|
|Minimum Order Quantity:||1KG|
|Packaging Details:||Aluminum foil bag , kraft paper bag|
|Delivery Time:||Within 7 days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||Can be customized according to customer requirements|
|Molecular Weight:||295.29448||Melting Point:||>220°|
chemical raw materials,
pharmaceutical raw materials
Entecavir hydrate CAS 209216-23-9 Pharmaceutical Grade Chemicals
Entecavir tablets, indications: this product is suitable for the treatment of chronic adult hepatitis b in patients with active virus replication, elevated serum transaminase ALT, or liver histology showing active lesions.
It should be white or whitish crystalline powder, odorless and tasteless, very slightly in water, slightly soluble in methanol and insoluble in ether.
|It is white crystalline powder, odorless and tasteless, very slightly in water, slightly in methanol and insoluble in ether.|
|Specific rotation||Should be between +24°~+28°||+27°|
|(1) HPLC||Retention time of the principal peak obtained from the test solution should be identical with that of the reference solution.||Retention time of the principal peal of Entecavir samples is identical with that of the reference standard.|
|(2) IR||IR spectrum of samples should be identical with that of the reference standard.||IR spectrum of samples is identical with that of the reference standard.|
|pH||Should be between 5.5~7.5||6.0|
|(1)Total impurity||Should be 0.3%max||0.10%|
|(2)maximum single impurity||Should be 0.1%max||0.03%|
|Enantiomer||Should be 0.2%max||0.01%|
|Methanol||Should be 0.3%max||Undetected|
|Dichloromethane||Should be 0.06%max||Undetected|
|N- hexane||Should be 0.029%max||Undetected|
|Tetrahydrofuran||Should be 0.072%max||Undetected|
|N,N-dimethylformamide||Should be 0.088%max||Undetected|
|Toluene||Should be 0.089%max||Undetected|
|Water||Should be between 5.8%~6.5%||6.3%|
|Residue on ignition||Should be 0.1%max||0.0%|
|Heavy metal||Should be 20ppmmax||Complies|
|Assay||98.0%~102.0%(C12H15N5O3) calculated on anhydrous basis||100.1%|
1. This product is suitable for the treatment of chronic adult hepatitis b with active virus replication, continuously elevated serum alanine aminotransferase (ALT) or liver histology showing active lesions.
2. It is also applicable to the treatment of children with nucleoside initiation for the treatment of chronic compensatory liver disease with HBV infection from 2 years old to <18 years old, who have evidence of active virus replication and sustained elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis.See usage and dosage for specific application methods.
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