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  • About Mitomycin-C Kyowa
  • Mechanism of Action
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  3. Stability

About Mitomycin-C Kyowa

Stability

Mitomycin-C is stable at ordinary temperatures in the crystalline state.
In the form of a solution, Mitomycin-C is susceptible to pH changes; it is stable at pH 8.0 but becomes less stable with decreasing pH at 7.0 or lower.

Stability of the active ingredient in the crystalline state

One or 2 mg of Mitomycin-C crystals was stored in an ampoule that was heat-sealed under vacuum. The changes in drug content (% of the initial drug content) as measured by a bioassay method are shown below. (Values represent the mean of 3 or 4 lots.)

Stability at body/room temperature
Stability at high temperature

Stability of the product under different storage conditions

Stability of the product before Reconstitution

The results (means of 2 lots) from a stability study of the drug product stored at room temperature are shown below. The drug product was analyzed using a bioassay method and a high performance liquid chromatography (HPLC) method.

Stability at room temperature

Stability of the product after Reconstitution

A 2mg vial of Mitomycin-C Kyowa was reconstituted with 5 mL each of water for injection, physiological saline, and 5% glucose. The resulting samples were stored at room temperature, in a cold place (approximately 5°C), or in a freezer (-20°C), and monitored for stability. The content (%) of Mitomycin-C was measured by an HPLC method. The results are shown below. In a cold place or at room temperature, Mitomycin-C remained stable for a long time, whereas crystals of Mitomycin-C were formed in a freezer.
Mitomycin-C Kyowa reconstituted with 5% glucose showed a change in appearance and a decrease in content slightly earlier than that reconstituted with water for injection or physiological saline. At high temperatures, the appearance changed and the drug content decreased in a short time.

Stability at room/low temperature
Stability at body/high temperature

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