化學(xué)藥物質(zhì)量控制分析方法驗(yàn)證技術(shù)指導(dǎo)原則doc17-質(zhì)量工具-展示頁
2024-08-29 17:01本頁面
【正文】 ............................ 3 鑒別反應(yīng) ................................................................................................... 3 雜質(zhì)檢查 ................................................................................................... 4 含量測定 ................................................................................................... 4 （二） 線性 ....................................................................................................... 5 （三） 范圍 ....................................................................................................... 5 含量測定 ................................................................................................... 5 制劑含量均勻度 ........................................................................................ 5 溶出度或釋 放度 ........................................................................................ 6 雜質(zhì) ........................................................................................................... 6 （四） 準(zhǔn)確度 ................................................................................................... 6 含量測定 ................................................................................................... 6 雜質(zhì)定量試驗(yàn) ........................................................................................... 7 （五） 精密度 ................................................................................................... 7 重復(fù)性 ....................................................................................................... 7 中間精密度 ............................................................................................... 8 重現(xiàn)性 ....................................................................................................... 8 （六） 檢測限 ................................................................................................... 8 直觀法 ....................................................................................................... 8 信噪比法 ................................................................................................... 8 （七） 定量限 ................................................................................................... 9 直觀法 ....................................................................................................... 9 信噪比法 ................................................................................................... 9 （八） 耐用性 ................................................................................................. 10 （九） 系統(tǒng)適用性試驗(yàn) ........................................................................
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