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Discussion on the container closure integrity of rubber stopper/glass container
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Jun-wei MA, Di-liang GUO, Juan LIU, Yong-hui LIU
Chinese Journal of New Drugs | 2021, 30(5) : 394 - 398
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收藏切换
Chinese Journal of New Drugs | 2021, 30(5): 394-398
Discussion on the container closure integrity of rubber stopper/glass container
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Jun-wei MA, Di-liang GUO, Juan LIU, Yong-hui LIU
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2021-03-15
Outline
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Research on container closure integrity (CCI) is an important part of drug development. This article focuses on the CCI research of the life cycle of the rubber stopper/glass container, including packaging design, production, and stability research, and discusses the MALL establishment of rubber stopper/glass container.

rubber stopper/glass container  /  container closure integrity (CCI)  /  product life cycle  /  maximum allowable leakage limit (MALL)
马骏威, 郭涤亮, 刘涓, 刘永辉. 胶塞/玻璃瓶容器密封完整性研究的探讨. 中国新药杂志, 2021 , 30 (5) : 394 -398 .
Jun-wei MA, Di-liang GUO, Juan LIU, Yong-hui LIU. Discussion on the container closure integrity of rubber stopper/glass container[J]. Chinese Journal of New Drugs, 2021 , 30 (5) : 394 -398 .
Year 2021 volume 30 Issue 5
29
11
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  • Online Date:2026-10-29
  • Published:2021-03-15
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  • Accepted:2020-12-29
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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