Entecavir

PRODUCT NAME

Entecavir           

CAS NO.

142217-69-4

APPEARANCE

white or almost white crystalline

SPECIFICATION

99%

MOLECULAR FORMULAF

C12H15N5O3·H2O   

FUNCTION

This product is mainly used in the virus active, serum ALT ALT rising or liver histology showed activity of adult chronic lesions of hepatitis b treatment.

[Description ]

It should be white or whitish crystalline powder, odorless and tasteless, very slightly in water, slightly soluble in methanol and insoluble in ether.

Specific rotation

Should be between +24°~+28°

[Identification]

(1)   HPLC

Retention time of the principal peak obtained from the test solution should be identical with that of the reference solution.

(2)   IR

IR spectrum of samples should be identical with that of the reference standard.

[Test]

pH

Should be between 5.5~7.5

Related substances

(1)Total impurity

Should be 0.3%max

(2)maximum single impurity

Should be 0.1%max

Enantiomer

Should be 0.2%max

Methanol

Should be 0.3%max

Dichloromethane

Should be 0.06%max

N- hexane

Should be 0.029%max

Tetrahydrofuran

Should be 0.072%max

N,N-dimethylformamide

Should be 0.088%max

Toluene

Should be 0.089%max

Water

Should be between 5.8%~6.5%

Residue on ignition

Should be 0.1%max

Heavy metal

Should be 20ppmmax

Assay

98.0%~102.0%(C12H15N5O3) calculated on anhydrous basis