Beyond-Use Dating and Stability Flashcards
7 cards from real MCC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Beyond-Use Dating and Stability flashcards as text
Why is pH a critical factor in the stability of compounded preparations?
Answer: Specific pH ranges minimize degradation pathways such as hydrolysis and optimize drug stability
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.
Which of the following is a classic sign of physical instability in a compounded emulsion?
Answer: Phase separation or creaming
Phase separation or creaming indicates that the emulsion's dispersed and continuous phases are no longer uniformly mixed, signaling a loss of physical stability.
What is the primary role of an antioxidant excipient in a compounded preparation?
Answer: To prevent or slow the oxidative degradation of drug molecules
Antioxidants such as ascorbic acid or sodium metabisulfite are preferentially oxidized, thereby protecting drug molecules susceptible to oxidative degradation and extending stability.
Which container type is required for storage of photosensitive compounded preparations to prevent light-induced degradation?
Answer: Amber or opaque containers that block UV and visible light
Amber or opaque containers must be used for photosensitive preparations to block UV and visible light that would otherwise cause photolytic degradation.
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?
Answer: Accelerated microbial growth and chemical degradation may render it unsafe before the labeled BUD
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.
Which USP chapter specifically establishes beyond-use dating categories and requirements for sterile compounded preparations?
Answer: USP
USP governs sterile compounding and defines Category 1 and Category 2 CSP BUD assignments, environmental monitoring requirements, and personnel training standards.
Which of the following compounded preparation types would typically receive the shortest beyond-use date under USP guidelines?
Answer: An aqueous oral solution compounded from a manufactured drug product stored at room temperature
Aqueous preparations compounded from manufactured products and stored at room temperature receive the shortest BUDs because water promotes both microbial growth and chemical hydrolysis, and room temperature storage provides no protective cooling.