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Entecavir hydrate CAS 209216-23-9 Pharmaceutical Grade Chemicals

Basic Information
Place of Origin: CHINA
Brand Name: MOSINTER
Certification: COA
Model Number: Antibiotic Drugs API - 5
Minimum Order Quantity: 1KG
Price: Negotiation
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
Detail Information
Name: Entecavir Hydrate CAS: 209216-23-9
Appearance: Powder Molecular Formula: C12H17N5O4
Molecular Weight: 295.29448 Melting Point: >220°
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Product Description

Entecavir hydrate CAS 209216-23-9 Pharmaceutical Grade Chemicals

 

Description:

 

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.

 

Specifications:

 

Items

Specifications

Results

[Description ]

 

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°

 

[Identification]

   
(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.
[Test]    
pH Should be between 5.5~7.5 6.0
Related substances    
(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%

 

Application:

 

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.

 

Our strengths:

 

We can customize according to customer's requirement.

If you have any question pls mail us or call us.

 

 

 

Contact Details
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Phone Number : +86 18989305995

WhatsApp : +18989305995