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    藥品穩定性試驗室的標準修定后要求


    藥品穩定性試驗室,藥品穩定性試驗室價格,藥品穩定性試驗室標準(http://www.modfert.com/products-102169-0-0.html

    ICH Q1F“國際氣候帶地區注冊申報穩定性數據Q1A(R)所作修正,修正如下:
    中間條件環境由30±2/60%RH±5%修正為30±2/65%RH±5%

    2.1.7.1 原料藥-儲存條件-通常情況

    2.2.7.1 制劑-儲存條件-通常情況

    2.2.7.3 半透過性容器包裝的制劑

          3 術語-“中間條件檢測”

    長期實驗儲存條件30±2/65%RH±5%可以替換25±2/60%RH±5%

    2.1.7.1 原料藥-儲存條件-通常情況

    2.2.7.1 制劑-儲存條件-通常情況

    3. 長期實驗儲存條件增加30±2/35%RH±5%作為25±2/40%RH±5%的可替換條件,其相應的失水率考察舉例如下列章節中:

    2.2.7.3半透過性容器包裝的制劑

     

    本修正指南頒布三年內,建議向各ICH機關提交的注冊申請內容包括中間儲存條件30±2/65%RH±5%全部試驗數據。
     

    藥品是與我們生活密切相關,從上述國家頻布的條例中不難看到,國家對藥品的穩定性能各關相環節把關的是非常嚴的。環儀儀器藥品穩定性試驗室,能讓您在時時監控到藥品的狀態。環儀的藥品穩定性試驗室系統雙系統,能停機時間不超過半小時,如一臺系統出現故障時,另一臺系統將自動啟動,二套系統可定期相互更換使用,壽命更長;出現故障時,通過短信報警功能,發布短信到操作者手機上,不時24小時守假機臺旁。更多資料歡迎來電咨詢:0769-83482055/15322932685

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