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Lyophilized preparation containing high purity PTH and method for producing the same
专利权人:
旭化成ファーマ株式会社
发明人:
西尾 文秀,前島 卓治,三留 佳郎
申请号:
JP2016183054
公开号:
JP6258426B2
申请日:
2016.09.20
申请国别(地区):
JP
年份:
2018
代理人:
摘要:
[Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like. [Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/
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