PROCESS FOR PRODUCTION OF BIVALIRUDIN

PROCESS FOR PRODUCTION OF BIVALIRUDIN

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...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: ZAOVI Gil, HAGI Alon, BUTILCA Gabriel-Marcus, EIDELMAN Chaim, TOVI Avi, SHUSHAN Shimon, BAR-OZ Leah, IVCHENKO Alexander, GADI Tehila
Format: Patent
Sprache:eng
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung: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%.