Transcription of 美國與歐盟對藥品包材可浸出物 (extractables) 與可 …
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美國與歐盟對藥品包材可浸出物 (extractables) 與可 …
RegMed 2015 Vol. 52 1 (extractables) (leachables) / 1 GMP DMF ( ) guidance for industry: container closure systems for packaging human drugs and biologics(1) Guideline on plastic immediate packaging materials(2) (packaging component) (materials of construction) (extractables) (leachables) (extraction) (1,2,3) (migration) (2,3)
RegMed 2015 Vol. 52 7 由於美國藥典 <1664> 草案尚未正式生效，美國法規中類似可滲出物 限量規定的部分，依藥品包裝材料相關之指引 Guidance for industry:
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