摘要 |
The invention relates to methods for the preparation of high purity Bivalirudin. The polypeptide is prepared in a high purity of at least 98.5% (by HPLC), wherein the total impurities amount to less than 1.5%, comprising not more than 0.5% [Asp9- Bivalirudin] and each is impurity less than 1.0%, and preferably having a purity of at least about 99.0% by HPLC, wherein the total impurities amount to less than 1.0%, comprising not more than 0.5% [Asp9-Bivalirudin] and each impurity is less than 0.5%. |
申请人 |
NOVETIDE, LTD.;TEVA PHARMACEUTICALS USA, INC.;TOVI, AVI;EIDELMAN, CHAIM;SHUSHAN, SHIMON;ALON, HAGI;IVCHENKO, ALEXANDER;BUTILCA, GABRIEL-MARCUS;BAR-OZ, LEAH;GADI, TEHILA |
发明人 |
TOVI, AVI;EIDELMAN, CHAIM;SHUSHAN, SHIMON;ALON, HAGI;IVCHENKO, ALEXANDER;BUTILCA, GABRIEL-MARCUS;BAR-OZ, LEAH;GADI, TEHILA |