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高純度含PTH冷凍乾燥製劑及其製造方法
专利权人:
ASAHI KASEI PHARMA CORPORATION;旭化成制藥株式會社
发明人:
Fumihide NISHIO,Takuji MAEJIMA,Yoshiro MITOME,西尾文秀,前島卓治,三留佳郎
申请号:
HK14103239.9
公开号:
HK1190304B
申请日:
2014.04.03
申请国别(地区):
HK
年份:
2016
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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