非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.203931884394350939446893943064393993739406170.14
210.363977341398401139806760.12
单位质量响应值RSD%判断
386335.00384235.140.39数据可信
供试品溶液-4226A批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12517341-251734158.80456.5115.5358.8056.5115.54
22727661-272766163.71763.72
31845278-184527843.10543.10
42498197-249819758.35758.36
52101866-210186649.09949.10
62824778-282477865.98565.99
10min13731816-373181687.17386.303.7887.3086.433.79
23745190-374519087.48687.63
33496622-349662281.67981.78
43828164-382816489.42489.55
53548710-354871082.89683.01
63816616-381661689.15489.30
15min14021250-402125093.93494.041.3494.2694.361.36
24027941-402794194.09194.43
33936840-393684091.96392.24
44088779-408877995.51295.84
54006656-400665693.59393.89
64072016-407201695.12095.47
20min14122293-412229396.29597.051.1896.8397.581.18
24132111-413211196.52497.07
34090292-409029295.54796.03
44214201-421420198.44298.98
54205869-420586998.24798.75
64163613-416361397.26097.82
30min14156883-415688397.10397.951.2697.8598.691.26
24178553-417855397.60998.37
34126822-412682296.40197.09
44202666-420266698.17298.93
54279427-427942799.965100.68
64214648-421464898.45299.22
45min14164982-416498297.29298.291.2698.2599.251.25
24200861-420086198.13099.11
34144917-414491796.82397.73
44215891-421589198.48199.46
54295073-4295073100.331101.27
64225740-422574098.71199.70
60min14159858-415985897.17298.521.4598.3599.701.44
24212926-421292698.41299.61
34153290-415329097.01998.14
44212293-421229398.39799.59
54317403-4317403100.852102.02
64249762-424976299.272100.48
极限14184644-418464497.75198.501.2999.1599.901.29
24209647-420964798.33599.75
34144648-414464896.81798.16
44210073-421007398.34599.76
54302800-4302800100.511101.90
64249146-424914699.258100.69
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.203983373398306439813443973461397559039793660.12
210.363973176397398439735800.02
单位质量响应值RSD%判断
390133.92383550.191.21数据可信
供试品溶液-4226A批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12619912-261991260.95759.478.1060.9659.478.11
22524763-252476358.74458.74
32736117-273611763.66163.66
42198125-219812551.14451.14
52766858-276685864.37664.38
62490991-249099157.95857.96
10min13769400-376940087.70387.021.3287.8487.151.33
23776746-377674687.87488.00
33769942-376994287.71587.86
43656176-365617685.06885.18
53764198-376419887.58287.72
63703533-370353386.17086.30
15min14023112-402311293.60693.601.2193.9493.921.22
24086653-408665395.08495.41
34048822-404882294.20494.54
43988807-398880792.80893.11
54041105-404110594.02494.36
63947982-394798291.85892.18
20min14229112-422911298.39997.271.3098.9497.801.29
24103507-410350795.47696.01
34164342-416434296.89297.44
44230590-423059098.43398.94
54219437-421943798.17498.72
64135847-413584796.22996.75
30min14219331-421933198.17197.971.2598.9398.721.24
24149205-414920596.54097.29
34173204-417320497.09897.86
44237627-423762798.59799.32
54296602-429660299.969100.73
64189240-418924097.47198.21
45min14237552-423755298.59598.441.2799.5799.411.26
24161509-416150996.82697.79
34191192-419119297.51698.49
44265063-426506399.235100.18
54312137-4312137100.330101.32
64218956-421895698.16299.12
60min14176824-417682497.18297.891.2898.3899.081.26
24158981-415898196.76797.95
34160050-416005096.79297.99
44272682-427268299.412100.58
54274577-427457799.457100.67
64200020-420002097.72298.89
极限14173700-417370097.10997.590.8398.5298.990.80
24247185-424718598.819100.21
34167541-416754196.96698.37
44228556-422855698.38699.77
54171047-417104797.04898.48
64177740-417774097.20398.59
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