非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554217600422124542129384200151419731242098490.26
210.704273677427146642725720.04
单位质量响应值RSD%判断
399037.82399305.790.05数据可信
供试品溶液-250603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%
5min12631038-263103859.26257.007.0459.2657.007.04
22608114-260811458.74658.75
32209810-220981049.77449.77
42689040-268904060.56860.57
52606668-260666858.71358.71
62438710-243871054.93054.93
10min13979924-397992489.64489.172.5889.7489.272.58
23860276-386027686.94987.05
33867561-386756187.11387.20
43888636-388863687.58887.69
54081981-408198191.94392.04
64075236-407523691.79191.88
15min14225760-422576095.18295.901.4795.4396.141.46
24245329-424532995.62295.87
34341598-434159897.79198.02
44162928-416292893.76694.01
54265601-426560196.07996.33
64303435-430343596.93197.18
20min14248401-424840195.69296.721.3896.1097.121.37
24313328-431332897.15497.56
34373087-437308798.50098.89
44207081-420708194.76195.16
54293758-429375896.71397.12
64329394-432939497.51697.92
30min14253243-425324395.80196.891.3496.3797.461.33
24332231-433223197.58098.14
34372158-437215898.47999.03
44219303-421930395.03695.60
54294884-429488496.73997.31
64338858-433885897.72998.30
45min14254718-425471895.83497.291.4096.5698.021.39
24378207-437820798.61599.34
34389807-438980798.87799.60
44250930-425093095.74996.47
54300468-430046896.86497.60
64342696-434269697.81598.55
60min14242905-424290595.56897.031.2896.4597.921.27
24323303-432330397.37998.27
34393510-439351098.96099.84
44255186-425518695.84496.72
54302710-430271096.91597.81
64329587-432958797.52098.41
极限14232445-423244595.33296.901.3196.3897.951.30
24320419-432041997.31498.37
34381410-438141098.68799.74
44244709-424470995.60896.65
54298704-429870496.82597.88
64334418-433441897.62998.69
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