USP<1663>“药用包装/给药系统相关可提取物的评估”、USP<1664>“药用包装/给药系统相关浸出物的评估”。在上述指导原则中,药包材的相容性研究均包括可提取物研究、浸出物研究,同时,提取物和浸出物研究结果均需进行相应的毒理学风险评估从而实现与相容性相关的安全性评价。 药包材的部分变更事项,可能会触发药包材企...
2. 容器封闭系统检查(USP <661.2>):参考 USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 指南进行全面的可提取物测试,以衡量材料成分的潜在影响。 3. 包装产品的可浸出物分析:引入了<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packagi...
2. 容器封闭系统检查(USP <661.2>):参考 USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 指南进行全面的可提取物测试,以衡量材料成分的潜在影响。 3. 包装产品的可浸出物分析:引入了<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packagi...
2. 容器封闭系统检查(USP <661.2>):参考 USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 指南进行全面的可提取物测试,以衡量材料成分的潜在影响。 3. 包装产品的可浸出物分析:引入了<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packagi...
2. 容器封闭系统检查(USP <661.2>):参考 USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 指南进行全面的可提取物测试,以衡量材料成分的潜在影响。 3. 包装产品的可浸出物分析:引入了<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packagi...
关注材料容器系统的相容性: <1663><1664><1664.1>对药品包装系统的可提取物、浸出物、经口鼻吸入给药制剂的浸出物提供研究评价指南。 3 USP最新进展 USP论坛(pharmacopeia forum, PF)是USP标准建立与修订的在线信息发布平台。新标准或修订标准在正式生效前, 通常以提案形式在PF上公示, 每两个月就拟增修订药典标准...
Overall the philosophies link to USP <1661>, <1663>, <1664> and <1664.1> in terms of risk management. What are the expectations for elemental analysis? According to USP <661.1> elemental analysis is assessed where “deemed necessary and appropriate by the end user” and USP <1661> ...
Further information regarding packaging systems testing may be found in Assessment of Extractables Associated with Pharma- ceutical Packaging/Delivery Systems á1663ñ and Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/ Delivery Systems á1664ñ. G e CONTAINER–CLOSURE ...
USP-1664-Leachable-包材析出物研究方法.pdf,Accessed from by copps4 on Tue Dec 27 20:14:28 EST 2016 1850 á1664ñ Assessment of Drug Product Leachables / General Information USP 39 á1664ñ ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACE
New General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems presents and describes best-demonstrated scientific practices for accomplishing an extractables assessment. New General Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical ...