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The Degradation of Mitomycin C Under Various Storage Methods
Robert M Kinast1, Kiran K Akula, Andrea E DeBarber
1*Devers Eye Institute at Legacy Health †RS Dow Neurobiology Laboratories, Legacy Research Institute ‡Oregon Health & Science University, Portland, OR.
Journal of Glaucoma
|May 29, 2015
Summary
Pharmacy preparation and storage conditions impact mitomycin C (MMC) stability. While initially stable, MMC degrades over 24 hours at room temperature, with clinical implications of degradants remaining unclear.
Area of Science:
- Pharmaceutical Sciences
- Oncology
- Drug Stability
Background:
- Mitomycin C (MMC) is a crucial chemotherapeutic agent.
- Understanding its stability under various pharmacy conditions is vital for effective treatment.
Purpose of the Study:
- To evaluate the stability of mitomycin C (MMC) solutions under common pharmacy preparation and storage conditions.
- To identify potential degradation products and assess their formation over time.
Main Methods:
- Utilized C18 reversed-phase high-performance liquid chromatography (HPLC) to assess MMC stability.
- Employed liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS) for degradation product identification.
- Compared stability across refrigeration, freezing, shipment on-ice, and dry powder formulations at various time points.
Main Results:
- All tested preparation and storage methods showed similar initial stability of MMC upon reaching room temperature.
- Significant degradation of MMC was observed over a 24-hour period for 2-week refrigerated and shipment on-ice conditions.
- Two primary degradants, cis-hydroxymitosene and trans-hydroxymitosene, were identified in small amounts (<3.2%) across samples.
Conclusions:
- Initial stability of mitomycin C (MMC) is comparable across various preparation and storage methods.
- Extended room temperature storage leads to measurable degradation of MMC.
- The clinical significance of observed MMC degradants requires further investigation.
