CSPT CSPT - Compounded Sterile Preparation Technician Beyond-Use Dating and Stability Questions and Answers 4

Question 1

According to USP <797>, what is the BUD for a Category 1 CSP stored at controlled room temperature when prepared in a non-ISO-classified environment?

Accepted Answer

12 hours

Answer

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

Question 2

A CSP is prepared from multiple non-sterile ingredients. Under USP <797>, this preparation is classified as which sterility risk level prior to sterilization?

Accepted Answer

Category 3

Answer

CSPs prepared from non-sterile ingredients require sterilization and are classified as Category 3 under USP <797> (2023 revision).

Question 3

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

Accepted Answer

Technician certification level

Answer

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

Question 4

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?

Accepted Answer

Extrapolate the BUD using the Q10 rule to adjust for temperature

Answer

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.

Question 5

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

Accepted Answer

Hydrolytic degradation of the beta-lactam ring

Answer

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

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 4