110年第二次調劑學與臨床藥學解析20

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

 

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