恩替卡韦

恩替卡韦

产品名称：恩替卡韦

英文名称：Entecavir
 
化学名：9-(4-羟基-3-羟甲基-2-亚甲基环戊-1-基)鸟嘌呤一水合物

CAS号: 209216-23-9
 
分子式:C12H17N5O4
 
分子量:295.29448
 
含量:≥99.7%
 
单一杂质:＜0.1%
 
外观:白色结晶性粉末。
 
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%