thereto,foruseinparenteralpreparations,andforuseinmedicaldevices,implants,and othersystems. Thesethreetestsareappliedtomaterialsormedicaldevices,ifthereisaneedfor classificationofplasticsandotherpolymersbasedoninvivobiologicalreactivity testing. Forthepurposeofthischapter,thesedefinitionsapply:theSampleisthespecimenunder...
usp(PF)-88 下载积分: 100 内容提示: 94 〈87〉 Biological Reactivity Tests, In Vitro / Biological Tests USP 35(mildly reactive). Repeat the procedure if the suitability of logical Reactivity Tests, In Vitro 〈87〉 have indicated significantthe system is not confirmed. For dose-response ...
These three tests are applied to materials or medical devices, if there is a need for classification of plastics and other polymers based on in vivo biological reactivity testing. For the purpose of this chapter, these definitions apply: the Sample is the specimen under test or an extract ...
parenteralpreparations,andforuseinmedicaldevices,implants,andother systems. Thesethreetestsareappliedtomaterialsormedicaldevices,ifthereisaneed forclassificationofplasticsandotherpolymersbasedoninvivobiological reactivitytesting. Forthepurposeofthischapter,thesedefinitionsapply:theSampleisthe ...
if there is a need for classification of plastics and other polymers based on in vivo biological reactivity testing.For the purpose of this chapter, these definitions apply: the Sample is the specimen under test or an extract prepared from such a specimen. A Blank consists of the same quantity...
These three tests are applied to materials or medical devices, if there is a need for classification of plastics and other polymers based on in vivo biological reactivity testing. For the purpose of this chapter, these definitions apply: the Sample is the specimen under test or an extract ...
But the standard that I'm going to focus on today is USP or the organization I should say, the US Pharmacopoeia. And when I go through the history, actually, we're going to talk specifically about US Pharmacopoeia Standard <381>, or Chapter 381, as it's called. And that really ...
If the component meets the plastic class VI requirements according to USP general chapter <88>, it is not necessary to test the component according to <87>. 如果部件符合USP通则<88>的塑料级别VI的要求,则不需要根据<87>对部件进行检测。 4. POLYMERIC MATERIALS OF CONSTRUCTION 结构中的聚合物料 4.1...
highlight=661.2© 2019 USPC〈 〈 661.2〉 〉 PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE (This chapter will become official on May 1, 2020. Early adoption of the requirements in this chapter and its companion chapter Plastic ... ...
If the component meets the plastic class VI requirements according to USP general chapter <88>, it is not necessary to test the component according to <87>. 如果部件符合USP通则<88>的塑料级别VI的要求,则不需要根据<87>对部件进行检测。