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wuto

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[求助] 帮忙翻译一下,先谢了

Where stability studies have been performed to establish the expiration date of a particular dosage form in the appropriate polyethylene container, then
any other polyethylene container meeting these requirements may be similarly used to package such a dosage form, provided that the appropriate stability programs are expanded to include the alternative container, in order to ensure that the identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period。这句话真长。
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ssssllllnnnn

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wuto: 金币+18, 翻译EPI+1, ★有帮助, 谢谢回答 2015-11-12 09:01:25
确实够长:

测定了稳定性,以确立在适当聚乙烯容器中某特点剂型的有效期,进而确定符合这些条件的其他聚乙烯容器可同样用于这一剂型的包装,前提是那些恰当的稳定性方案在这替代容器中得到保证,以确保在整个保质期中该剂型的特性、药效、品质和纯度得以维持。
2楼2015-11-12 00:26:02
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jiangguofeng

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wuto: 金币+2 2015-11-12 09:01:34
在已经为建立专用聚乙烯容器中的特定剂型的有效期而完成了稳定性研究的情况下,其他符合要求的聚乙烯容器同样可以用于包装这种剂型,其前提是这个专用的稳定性方案扩展到包含这种替代容器,以确保在整个有效期内这种剂型的一致性、浓度、品质和纯度得到维持?
3楼2015-11-12 08:33:12
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