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

According to USP , what is the BUD for a Category 1 CSP stored at controlled room temperature when prepared in a non-ISO-classified environment?

Answer: 12 hours

Category 1 CSPs prepared outside of ISO-classified environments have a BUD of 12 hours at controlled room temperature.

A CSP is prepared from multiple non-sterile ingredients. Under USP , this preparation is classified as which sterility risk level prior to sterilization?

Answer: Category 3

CSPs prepared from non-sterile ingredients require sterilization and are classified as Category 3 under USP (2023 revision).

Which factor does NOT directly affect the chemical stability and BUD assignment of a compounded sterile preparation?

Answer: Technician certification level

Technician certification level is a personnel qualification factor and does not directly affect the chemical stability of a CSP.

A pharmacy is assigning a BUD based on published stability data. The referenced study was conducted at 5°C, but the CSP will be stored at 25°C. What is the appropriate action?

Answer: Extrapolate the BUD using the Q10 rule to adjust for temperature

The Q10 rule can be applied to extrapolate BUD from stability data obtained at a different temperature, accounting for increased degradation rates at higher temperatures.

An admixture of ampicillin in NS is prepared. The pharmacist notes that the solution turns yellow over time. This color change most likely indicates:

Answer: Hydrolytic degradation of the beta-lactam ring

Yellowing of ampicillin solutions is a sign of hydrolytic degradation of the beta-lactam ring, indicating loss of potency.

For a CSP that lacks applicable stability data, USP default BUDs are assigned. Which condition results in the longest allowable default BUD for a Category 2 CSP?

Answer: Frozen storage

Frozen storage at ≤-25°C allows the longest default BUD for Category 2 CSPs because low temperatures slow microbial growth and chemical degradation.

A total parenteral nutrition (TPN) admixture contains calcium and phosphate. The primary stability concern when assigning BUD is:

Answer: Calcium-phosphate precipitation

Calcium-phosphate precipitation is the critical stability concern in TPN admixtures, potentially causing fatal pulmonary emboli if infused.