Safe storage of 14C-labeled active pharmaceutical ingredients (APIs) is of vital importance for drug development and compliance. Although the half-life of 14C is over several thousand years, the 14C-labeled molecules themselves may degrade due to chemical instability, autoradiolysis, and other factors. Furthermore, the 14C is a low energy beta emitter, but prolonged exposure or improper handling still poses potential safety risks. The purpose of storing radioactive labeled compounds is to protect the staff and the environment, and to ensure that the valuable radioactive materials maintain their scientific integrity in subsequent applications.
Amerigo Scientific provides long-term storage services for 14C-labeled APIs, allowing our clients to flexibly decide how and when to use their materials. Due to the long half-life of 14C, its radiological performance lasts for a long time. Our storage facilities are designed for safety and stability and offer multiple temperature options to maintain the integrity of the radiolabeled compounds. All storage rooms are continuously monitored for temperature by a Rees Scientific Environmental Monitoring System, which is compliant with 21 CFR Part 11. In addition, all storage rooms are equipped with full backup power supplies, so the storage of radiolabel compounds would not be affected in power outages or other emergencies. In addition, we maintain strict inventory control and perform periodic stability checks to track radiochemical stability over time, providing data to support retest dates or extended use.
For 14C-labeled APIs synthesized by our production services, safe and long-term storage can be achieved under the following conditions:
- Controlled room temperature (+25°C/60% RH)
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