MCC Beyond-Use Dating and Stability 3

Question 1

Why is pH a critical factor in the stability of compounded preparations?

Accepted Answer

Specific pH ranges minimize degradation pathways such as hydrolysis and optimize drug stability

Answer

Many drugs are most stable within a narrow pH range; formulating outside this range can accelerate hydrolysis, oxidation, or other degradation pathways and shorten the effective BUD.

Question 2

Which of the following is a classic sign of physical instability in a compounded emulsion?

Accepted Answer

Phase separation or creaming

Answer

Phase separation or creaming indicates that the emulsion's dispersed and continuous phases are no longer uniformly mixed, signaling a loss of physical stability.

Question 3

What is the primary role of an antioxidant excipient in a compounded preparation?

Accepted Answer

To prevent or slow the oxidative degradation of drug molecules

Answer

Antioxidants such as ascorbic acid or sodium metabisulfite are preferentially oxidized, thereby protecting drug molecules susceptible to oxidative degradation and extending stability.

Question 4

Which container type is required for storage of photosensitive compounded preparations to prevent light-induced degradation?

Accepted Answer

Amber or opaque containers that block UV and visible light

Answer

Amber or opaque containers must be used for photosensitive preparations to block UV and visible light that would otherwise cause photolytic degradation.

Question 5

A patient is instructed to store an aqueous compounded preparation under refrigeration with a 14-day BUD. If the patient stores it at room temperature instead, what is the pharmacist's primary concern?

Accepted Answer

Accelerated microbial growth and chemical degradation may render it unsafe before the labeled BUD

Answer

Storing a refrigeration-required aqueous preparation at room temperature accelerates microbial proliferation and chemical degradation, potentially making the product unsafe well before the labeled BUD expires.

MCC - Medication Compounding Certification Practice Test

MCC - Medication Compounding Certification Practice Test

MCC Beyond-Use Dating and Stability 3