Stability of Mometasone Furoate in a Cream Formulation

CNU IR > Chna Nan Annual Bulletin > No.30 (2004) > Item 310902800/21321

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Title:	Stability of Mometasone Furoate in a Cream Formulation Mometasone Furoate於乳膏中安定性之研究
Authors:	Chun-Ren Chen K. C. Sung Jeng-Fen Huang Yi-Hsin Lin Su-Jong Chen
Contributors:	藥學系
Keywords:	Mometasone Furoate Cream Stability Shelf life Mometasone Furoate 乳膏安定性架儲期
Date:	2004
Issue Date:	2009-06-01 09:12:03 (UTC+8)
Abstract:	Stability of 0.1% w/w mometasone furoate in a cream formulation in aluminum tubes or plastic bottles was studied. The samples were stored at 25±2℃/60±5%RH condition and assayed at three months intervals for one year for long term stability testing. The samples were also stored at 40±2℃/75±5%RH condition and assayed at two month intervals for six months for accelerated stability testing. A HPLC system with reverse phase column was used to assay the stability samples. The results were analyzed by the least squares linear regression and the lower 95% confidence intervals were also calculated. The shelf life of the cream formulation in either tubes or bottles is estimated over two years. 本研究旨在探討Mometasone Furoate在塑膠瓶裝及鋁質軟管裝乳膏劑中之藥品安定性及其架儲期之研究。本研究將不同包裝之Mometasone Furoate儲存在25±2℃/60±5%RH環境下一年，並在每三個月取樣一次來分析其藥品含量以評估其長期安定性。此外，本研究也將不同包裝之Mometasone Furoate在40±2℃/75±5%RH環境下儲存 6個月並每2個月取樣一次，以評估其加速安定性。所得到的含量數據以線性回歸及95%信賴區間之統計方式作分析，顯示Mometasone Furoate乳膏劑無論在塑膠瓶裝或鋁質管內皆具有超過兩年之藥品架儲期。
Relation:	嘉南學報(科技類)30期：p.141-148
Appears in Collections:	[Chna Nan Annual Bulletin] No.30 (2004) [Dept. of Pharmacy] Periodical Articles

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