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PROCÉDÉ DE LYOPHILISATION ET LYOPHILISAT TEVERELIX-TFA AINSI OBTENU
专利权人:
Antev Limited
发明人:
申请号:
EP18181960.8
公开号:
EP3590526A1
申请日:
2018.07.05
申请国别(地区):
EP
年份:
2020
代理人:
摘要:
The present invention relates to a lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps:a) providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio sufficient for providing an microcrystalline teverelix-TFA suspension without formation of a gel, andb) lyophilizating the lyophilization suspension, thereby providing a teverelix-TFA lyophilizate.The process provides the possibility of obtaining a "pure" teverelix-TFA lyophilizate i.e. without any undesirable residues in the composition.
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