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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
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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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