Lyophilized powder appears as a white or off-white lyophilized cake or powder. It possesses an extremely low moisture content-typically required to be ≤3%-with post-lyophilization water levels generally falling below 2%; this is a critical factor in ensuring stability and extending shelf life.
Lyophilized powder exhibits high stability, effectively mitigating the adverse effects of external factors such as temperature, humidity, and light exposure. It demonstrates excellent reconstitutability-as assessed by dissolution time and solution clarity-dissolving rapidly upon the addition of water. Storage stability is significantly influenced by ambient temperature, humidity, and packaging materials (specifically, the sealing integrity and moisture permeability of components such as rubber stoppers); therefore, storage in a low-temperature (e.g., 2–8°C) and low-humidity environment is recommended.