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(A)調製後之口服液劑室溫冷藏下可以存放14天 (B)調製後之外用乳劑，在不含防腐劑的情況下，於室溫冷藏可存放30天 (C)在非ISO 5環境下調製之注射劑，於冷藏情況下僅可存放一週14天   BUD by Type of Formulationa 非無菌製劑(以下製劑皆須添加antimicrobialnpreservatives，若沒添加就需要冷藏) 非水液劑(Nonaqueousn Formulations)6個月The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier.含水口服液劑(Water-Containingn Oral Formulations)冷藏14天The BUD is not later than 14 days when stored at controlled cold temperatures.含水外用劑(Water-Cont...
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(A)調製後之口服液劑室溫冷藏下可以存放14天 (B)調製後之外用乳劑，在不含防腐劑的情況下，於室溫冷藏可存放30天 (C)在非ISO 5環境下調製之注射劑，於冷藏情況下僅可存放一週14天   BUD by Type of Formulationa 非無菌製劑(以下製劑皆須添加antimicrobialnpreservatives，若沒添加就需要冷藏) 非水液劑(Nonaqueousn Formulations)6個月The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier.含水口服液劑(Water-Containingn Oral Formulations)冷藏14天The BUD is not later than 14 days when stored at controlled cold temperatures.含水外用劑(Water-Containingn Topical/Dermal and Mucosal Liquid and Semisolid Formulations)30天The BUD is not later than 30 days Ref:USP<795> 無菌製劑:依調製環境區分為以下三類 p.s.ISO 5屬於low-risk Ref: http://jerryfahrni.com/2015/07/what-usp-has-t.....看完整詳解