20.依據USP <797> Sterile Preparations之規範,low-risk compounded sterile preparations於冷藏條件下,beyond-use
date最長為多少天?
A.7
B.14
C.21
D.28
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答案:B
解析: 依據USP <797> Sterile Preparations之規範,不同類別compounded sterile preparations(CSP)於不同保存溫度的beyond-use date為:
USP <797>
Sterile Preparations |
室溫
(room temperature) |
冷藏(refrigeration) | 冷凍
(frozen) |
Low Risk | 48 hours or less | 14 days or less | 45 days or less |
Medium Risk | 30 hours or less | 9 days or less | 45 days or less |
High Risk | 24 hours or less | 3 days or less | 45 days or less |