恩替卡韋

產(chǎn)品名稱：恩替卡韋

英文名稱：Entecavir
 
化學(xué)名：9-(4-羥基-3-羥甲基-2-亞甲基環(huán)戊-1-基)鳥嘌呤一水合物

CAS號(hào): 209216-23-9
 
分子式:C12H17N5O4
 
分子量:295.29448
 
含量:≥99.7%
 
單一雜質(zhì):＜0.1%
 
外觀:白色結(jié)晶性粉末。
 
Test items             Acceptance criteria                      Result

Description            White to off-white  powder          White powder

Identification   The IR absorption spectrum of the sample    conform
                    must be concordant with entecavir
                       
Optical rotation     +24.0°—+28.0°(DMF:MOH=1:1 c=1%)       +26.7°

Water                  5.8%—6.5%                               6.2% 

Residue on ignition      ≤0.1%                                 0.07%

Related Substances      Total impurities ≤0.3%                 0.02%

                       Single impurity ≤0.1%                   0.01%
 
Assay(HPLC)              ≥99.7%                                99.9%