What kind of quality control test assesses the stability of radiopharmaceuticals?

Shelf-life determination tests are essential for assessing the stability of radiopharmaceuticals. These tests help establish how long a radiopharmaceutical maintains its efficacy, safety, and quality under specified storage conditions. During shelf-life determination, studies are conducted to monitor changes in the product over time, focusing on factors such as potency, purity, and potential degradation. This ensures that the radiopharmaceutical remains effective and safe for patient use throughout its labeled expiration date.

In contrast, uniformity tests generally evaluate the consistency of dosages among individual units, calibration tests are critical for ensuring that instruments operate within specified limits, and performance evaluation tests focus on the accuracy and reliability of the imaging technologies used. While all these tests play vital roles in quality control, they do not specifically assess the stability of radiopharmaceuticals in the same direct manner as shelf-life determination tests do.