Preparations under MEDIUM RISK conditions stored in a solid frozen state at -20 C have a BUD of how many days?

Preparations under MEDIUM RISK conditions stored in a solid frozen state at -20 C have a BUD of how many days?

• A. 45 days
• B. 15 days
• C. 30 days
• D. 60 days

Answer: (A)

The key idea is that beyond-use dating depends on both the risk level of the sterile preparation and the storage condition. For a medium-risk sterile preparation stored in a solid frozen state at -20°C, the standard guideline assigns a BUD of 45 days. Freezing slows degradation and preserves sterility, and -20°C is treated as a frozen condition long enough to justify this 45-day period under typical stability data. So 45 days is chosen because it aligns with the frozen-storage BUD for medium-risk CSPs. The shorter options (15 or 30 days) would not fit frozen storage standards for this risk level, and 60 days exceeds the usual frozen BUD for medium-risk preparations unless there is specific, additional stability data supporting a longer period.

The key idea is that beyond-use dating depends on both the risk level of the sterile preparation and the storage condition. For a medium-risk sterile preparation stored in a solid frozen state at -20°C, the standard guideline assigns a BUD of 45 days. Freezing slows degradation and preserves sterility, and -20°C is treated as a frozen condition long enough to justify this 45-day period under typical stability data.

So 45 days is chosen because it aligns with the frozen-storage BUD for medium-risk CSPs. The shorter options (15 or 30 days) would not fit frozen storage standards for this risk level, and 60 days exceeds the usual frozen BUD for medium-risk preparations unless there is specific, additional stability data supporting a longer period.