Final answer:
The BUD for medium-risk CSPs stored at room temperature is determined by factors such as long-term and short-term stability, post-preparative stability, and freeze-thaw cycle. Maintaining the mean concentration within ± 15% of nominal is also important.
Step-by-step explanation:
The BUD (Beyond Use Date) for medium-risk CSPs (Compounded Sterile Preparations) stored at room temperature is determined by several factors.
First, it is important to consider the long-term storage stability as well as the short-term stability at room temperature or during sample processing.
Additionally, post-preparative stability should be assessed at room temperature or under the specific storage conditions to be used during the study.
One specific consideration is the freeze-thaw cycle, which refers to the process of freezing and thawing the CSP.
It is important to ensure that the CSP remains stable and maintains its desired concentration throughout this cycle.
Furthermore, it is recommended that the mean concentration at each level within ± 15% of nominal be maintained, which helps ensure the accuracy and consistency of the CSPs.