CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 5

Question 1

Which analytical method is considered the gold standard for confirming chemical stability and potency retention in a CSP for BUD validation purposes?

Accepted Answer

Stability-indicating assay method (SIAM)

Answer

A stability-indicating assay method (SIAM) can differentiate the intact drug from its degradation products, making it the gold standard for potency confirmation.

Question 2

USP <797> requires that BUD labels on CSPs include which of the following elements?

Accepted Answer

Date and time of preparation, storage conditions, and BUD

Answer

BUD labels must include the preparation date and time, required storage conditions, and the beyond-use date/time to ensure safe patient use.

Question 3

A CSP is inadvertently stored at room temperature for 4 hours before being transferred to refrigeration. The assigned refrigerated BUD should be:

Accepted Answer

Recalculated to account for the time already elapsed at room temperature

Answer

Time stored at room temperature consumes stability, so the BUD must be recalculated to subtract the equivalent degradation already incurred.

Question 4

Which USP chapter establishes standards for particulate matter in injections and is relevant to the physical stability assessment of CSPs?

Accepted Answer

USP <788>

Answer

USP <788> specifies limits for particulate matter in injections, making it directly relevant to the physical stability evaluation of CSPs.

Question 5

An ophthalmology clinic requests a CSP eye drop with a 30-day BUD. The preparation uses only sterile commercial products as starting ingredients, and no sterility testing is performed. Under USP <797>, this request is:

Accepted Answer

Not achievable without sterility testing data supporting the extended BUD

Answer

Without sterility testing or peer-reviewed stability data, a 30-day BUD exceeds Category 2 defaults and cannot be assigned regardless of ISO classification.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 5