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

What is the maximum BUD for a Category 2 CSP stored frozen (-25°C to -10°C) when no stability data is available?

Answer: 180 days

USP permits a BUD of up to 180 days for Category 2 CSPs stored frozen when no product-specific stability data exists.

Which of the following is the BEST source to verify the chemical stability of a CSP ingredient before assigning a BUD?

Answer: Trissel's Handbook on Injectable Drugs

Trissel's Handbook on Injectable Drugs is a primary peer-reviewed reference for parenteral compatibility and stability data.

A compounded IV admixture shows a visible color change after 24 hours of storage. This observation most likely indicates:

Answer: Chemical degradation or incompatibility

A color change in a CSP is a physical sign of chemical degradation or drug incompatibility, warranting rejection.

Which pH range is generally considered most favorable for the stability of most aqueous injectable CSPs?

Answer: 4.5–8.5

Most parenteral drugs exhibit optimal stability in the pH range of 4.5–8.5, which also aligns with physiologic tolerability.

Under USP , which of the following actions is required when a CSP's BUD has been exceeded?

Answer: Discard the preparation immediately

Once a BUD has passed, the CSP must be discarded because its sterility and potency can no longer be assured.

Which type of container is preferred to minimize oxidative degradation when assigning a BUD to a light-sensitive CSP?

Answer: Amber vial or foil overwrap

Amber vials or foil overwraps block UV and visible light, reducing photodegradation and supporting a longer BUD.