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        維達列汀

        序號 項目 Item 指標(biāo) Specification
        1 外觀 Appearance 白色或類白色結(jié)晶性粉末
        White oralmost white crystalline powder
        2 鑒別 Identification IR:  corresponds to the standard
        UV:  corresponds to the standard
        3 比旋度(º)
        Specific optical rotation(º)
        1.0% methanol(20ºC), +96~+100
        3 含量  Assay (%)(dry bass) 99.0~101.0
        4 水分 Water(%) ≤0.5
        5 灰分Sulphated ash(%) ≤0.1
        6 相關(guān)物質(zhì)(HPLC)(%)
        Related substances
        impurity  A ≤0.1
        impurity  B ≤0.1
        impurity  C ≤0.1
        Max individual impurity ≤0.1
        Total impurities ≤0.5
        7 重金屬 Heavy Metals(as Pb)(ppm) ≤20
        8 殘留溶劑 Residual solvent(%) 2-butanone ≤0.5