CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers Flashcards
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Read the first 6 CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers flashcards as text
According to USP , what is the maximum beyond-use date (BUD) for a Category 1 compounded sterile preparation (CSP) stored at room temperature?
Answer: 12 hours
USP assigns Category 1 CSPs a BUD of 12 hours or less at controlled room temperature.
Which condition must be met for a CSP to qualify for Category 2 beyond-use dating under USP ?
Answer: Sterility testing performed per USP
Category 2 CSPs require sterility testing per USP to receive extended BUDs beyond Category 1 limits.
When no stability data is available, USP limits the BUD of a Category 2 aqueous CSP stored at controlled room temperature to a maximum of how many days?
Answer: 45 days
Without supporting stability data, Category 2 aqueous CSPs stored at room temperature have a maximum BUD of 45 days.
Which factor most directly shortens the assigned BUD of a compounded sterile preparation?
Answer: Elevated storage temperature
Higher storage temperatures accelerate chemical degradation and microbial growth, directly shortening the BUD.
A CSP is prepared using a commercial sterile ingredient. Under USP , the BUD of the final preparation may not exceed:
Answer: The BUD of the commercial product used
When a commercial sterile product is used as an ingredient, the CSP's BUD cannot exceed the BUD of that ingredient.
Which USP chapter governs sterility testing used to support extended beyond-use dates for Category 2 CSPs?
Answer:
USP Sterility Tests is the compendial standard used to validate sterility of Category 2 CSPs.
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