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YH-MIP-0103型 圖像法顯微計數法不溶性微粒儀

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  • 公司名稱 上海胤煌科技有限公司
  • 品牌
  • 型號 YH-MIP-0103型
  • 所在地 上海市
  • 廠商性質 生產廠家
  • 更新時間 2021/12/22 19:21:27
  • 訪問次數 769

聯系方式:楊濤 查看聯系方式

聯系我們時請說明是儀器網上看到的信息,謝謝!

溫馨提醒:請消費者做好對國際包裹的自身防疫措施,點我了解詳情。。。

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上市時間:2022-01-03

創新點:自動掃描,自動計數,自動識別顆粒形貌

圖像法顯微計數法不溶性微粒儀
測試范圍: 1 μm - 500 μm
應用范圍:乳劑、脂質體、滴眼劑、混懸劑、易產生氣泡劑型、粘度大制劑等

詳細信息 在線詢價

圖像法顯微計數法不溶性微粒儀


藥典規定

中國藥典0903章節的規定要求

0903不溶性微粒的檢測有兩個方法,光阻法不溶性微粒檢查顯微鏡不溶性微粒檢查。隨著光阻法收錄入藥典作為不溶性微粒檢查的一個方法以來,由于其操作簡單,檢測速度快,無需制樣等優點深受廣大用戶的喜愛,也便成了用戶偏愛和較高一種的檢查方法。而顯微鏡法不溶性微粒慢慢淡出人們視野。

 

 

常規顯微鏡不溶性檢查的缺陷

  • 常規顯微鏡不溶性微粒檢查大家會采用一臺簡單顯微鏡,人工進行計數。

此種操作的難點是:

  • 無法避免人為的原因導致計數的偏差,主觀性太強;

  • 重要的是人為計數對實驗員眼睛的要求較高,用眼過度會造成視力過早下降,引起一些不必要的眼疾;

  • 操作不規范性,測試結果重復性差

圖像法顯微計數法不溶性微粒儀

技術優勢特點

1-全濾膜自動掃描,操作簡單,節約時間;

2-顆粒自動計數,保護眼睛,減少人為操作誤差;

3-符合各國藥典/國標法規,一鍵自動出具對應報告;

4-符合21CFR Part11及GMP對數據完整性的要求;

設備構成

膜處理裝置

顯微鏡主機

全自動電動樣品臺

圖像處理及操作軟件


顯微鏡配置

根據用戶要求配置

奧林巴斯體式顯微鏡、奧利巴斯金相顯微鏡、徠卡金相顯微鏡、尼康金相顯微鏡等。

應用領域


應用范圍:乳劑、脂質體、滴眼劑、混懸劑、易產生氣泡劑型、粘度大制劑、無菌粉末、注射液、疫苗等


執行標準

中國藥典CP

美國藥典 USP 788、USP 789

歐洲藥典 EP

英國藥典 BP2013

日本藥典JP等


特點

直觀、形象、準確、測試范圍寬以及自動識別、自動統計、自動標定等特點; 避免激光法的產品缺陷,擴展檢測范圍;

 

YH-MIP-0103技術參數

image.png

 

正確的顯微計數法圖片.jpg

     

     

     

     

    上海胤煌科技有限公司

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    聯系人:楊濤

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    傳真:021-58220558

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