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KMID : 0869619990160010076
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Journal of Korean Society of Hospital Pharmacists
1999 Volume.16 No. 1 p.76 ~ p.78
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Stability Test of Mitomycin C in the Eye-drop Polyethylene Bottle by Temperature and Time
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Lee, Youn Jin/이윤진
Jeong, Yang Hee/Kim, Jae Youn/Cho, Young Hwan/Ro, Hwan Seong/정양희/김재연/조영환/노환성
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Abstract
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In the department of Ophthalmology in Asan medical center(AMC), we usually prescribe mitomycin (concentrated 400㎍/㎖, Q8) three times a day in the process of pterygium operation. Mitomycin´s shelf life is a week at room temperature or two weeks if refrigerated according to reference. However, we carried out a new experiment on this drug to find out how long its efficacy last in the eye-drop polyethylene bottle. This experiment concerns the stability of mitomycin.
The sample was mitomycin (2㎎/vial, Lot No. 216AHD) provided by Choongwae pharma corporation. 2㎎ vials of mitomycin were each reconstituted with 5㎖ of distilled water for injection giving a concentration of 400㎍/㎖. After filtering with 0.2㎛ filter, it was poured into an eye-drop polyethylene bottles. Then, 6 bottles were kept in condition of protection from light & room temperature and 6 bottles of the rest in the condition of protection from light & refrigerated temperature with closed. The residual potency of mitomycin C was measured by HPLC method.
As a result, we found out mitomycin is stable for 7 days when refrigerated and for 3 days at room temperature.
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