High purity pth-containing lyophilized products and production method thereof 机翻标题: 暂无翻译,请尝试点击翻译按钮。

源语言标题
(JP2017025088) 高​純度​PTH​含有​凍結​乾燥​製剤​および​その​製造​方法
公开号/公开日
JP2017025088 A 2017-02-02 [JP2017025088] / 2017-02-02
申请号/申请日
2016JP-0183054 / 2016-09-20
发明人
NISHIO FUMIHIDE;MAEJIMA TAKUJI;MITOME YOSHIRO;
申请人
ASAHI KASEI PHARMA;
主分类号
IPC分类号
A61K-038/22A61P-005/18C07K-014/635
摘要
(JP2017025088) PROBLEM TO BE SOLVED: To provide high purity PTH peptide-containing lyophilized products, to provide a production method thereof, and to provide an inspection method of the PTH related substance for inspecting the purity of PTH peptide-containing lyophilized products.SOLUTION: In the invention, presence of the PTH related substance produced during manufacturing process of PTH peptide-containing lyophilized products is confirmed.  Further, production of the PTH related substance concerned is found out to be prevented and reduced significantly by suppressing exposure to atmospheric environment in manufacturing facilities of pharmaceuticals, such as PTH peptide-containing solution.SELECTED DRAWING: Figure 2
机翻摘要
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地址
代理人
代理机构
;
优先权号
2011JP-0127698 2011-06-07
主权利要求

        
法律状态
(JP2017025088) LEGAL DETAILS FOR JP2017025088  Actual or expected expiration date=2032-05-31    Legal state=ALIVE    Status=PENDING     Event publication date=2016-09-20  Event code=JP/APP  Event indicator=Pos  Event type=Examination events  Application details  Application country=JP JP2016183054  Application date=2016-09-20  Standardized application number=2016JP-0183054     Event publication date=2017-02-02  Event code=JP/A  Event indicator=Pos  Event type=Examination events  Published application  Publication country=JP  Publication number=JP2017025088  Publication stage Code=A  Publication date=2017-02-02  Standardized publication number=JP2017025088     Event publication date=2017-04-21  Event code=JP/A521  Event type=Restitution or restoration  Written amendment  Effective date of the event=2017-04-21  JAPANESE INTERMEDIATE CODE: A523     Event publication date=2017-05-24  Event code=JP/A131  Event indicator=Neg  Event type=Examination events  Notification of reasons for refusal  Effective date of the event=2017-05-24  JAPANESE INTERMEDIATE CODE: A131     Event publication date=2017-07-21  Event code=JP/A521  Event type=Restitution or restoration  Written amendment  Effective date of the event=2017-07-21  JAPANESE INTERMEDIATE CODE: A523     Event publication date=2017-08-08  Event code=JP/A521  Event type=Restitution or restoration  Written amendment  Effective date of the event=2017-07-21  JAPANESE INTERMEDIATE CODE: A821
专利类型码
A
国别省市代码
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