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CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers Flashcards

6 cards from real CSPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers flashcards as text

  1. A single-dose vial of a sterile diluent is opened and used to prepare a CSP. Per USP , any unused portion must be discarded within:

    Answer: 12 hours

    Once a single-dose vial is opened or needle-punctured, USP requires discard within 12 hours to prevent microbial contamination.

  2. Which USP chapter provides guidance on particulate matter testing relevant to injectable CSP quality and stability?

    Answer:

    USP Particulate Matter in Injections sets limits for visible and sub-visible particulate contamination in injectable preparations.

  3. When assigning a BUD, which of the following takes LOWEST priority compared to the others?

    Answer: Pharmacist's experience-based estimate

    Pharmacist experience alone is the least reliable basis for BUD assignment; published data and regulatory limits take precedence.

  4. A Category 2 CSP is refrigerated at 2°C to 8°C with no stability data available. What is the maximum BUD allowed under USP ?

    Answer: 45 days

    Category 2 aqueous CSPs refrigerated without stability data are permitted a maximum BUD of 45 days under USP .

  5. Which of the following best describes 'physical stability' of a compounded sterile preparation?

    Answer: Absence of precipitation, cloudiness, or phase separation

    Physical stability refers to the preparation maintaining its original appearance without precipitation, turbidity, or phase separation.

  6. Which organization publishes the primary standards for beyond-use dating of compounded sterile preparations in the United States?

    Answer: USP

    The United States Pharmacopeia (USP) publishes Chapter , which is the authoritative standard for BUD assignment of CSPs.

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