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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.151950344195201619528851968441196894219585260.48
210.191930198192995019300740.01
单位质量响应值RSD%判断
192958.23189408.641.32数据可信
供试品溶液-2024092211批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1582950-58295027.44528.006.0227.4428.006.03
2589434-58943427.75027.75
3582936-58293627.44427.44
4647556-64755630.48630.49
5543728-54372825.59825.60
6621279-62127929.24929.25
10min11333132-133313262.76362.692.1962.8262.752.19
21275803-127580360.06460.13
31347846-134784663.45663.52
41341514-134151463.15763.23
51359368-135936863.99864.05
61331818-133181862.70162.77
15min11623104-162310476.41576.431.0776.6276.631.06
21624306-162430676.47176.67
31636656-163665677.05377.25
41626818-162681876.58976.80
51638577-163857777.14377.34
61590557-159055774.88275.09
20min11749820-174982082.38082.701.2882.7583.071.27
21781428-178142883.86884.23
31764792-176479283.08583.46
41754263-175426382.58982.97
51771900-177190083.42083.79
61717535-171753580.86081.23
30min11878937-187893788.45989.121.3389.0189.671.32
21926768-192676890.71191.26
31904672-190467289.67190.23
41886849-188684988.83189.39
51905780-190578089.72390.28
61854429-185442987.30587.86
45min11971891-197189192.83593.571.4393.5994.321.42
22022166-202216695.20295.96
32007363-200736394.50595.26
41973565-197356592.91493.67
52003690-200369094.33295.09
61946206-194620691.62692.37
60min12017275-201727594.97295.701.2895.9396.661.27
22067811-206781197.35198.32
32048499-204849996.44297.41
42016929-201692994.95695.92
52047478-204747896.39497.36
61998669-199866994.09695.04
极限12046634-204663496.35497.121.5297.5298.291.50
22100571-210057198.893100.07
32093702-209370298.57099.75
42035730-203573095.84197.02
52074590-207459097.67098.85
62026151-202615195.39096.55
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.151953914195552519556031955852195568619553160.05
210.191964729196677419657520.08
单位质量响应值RSD%判断
192641.97192909.910.10数据可信
供试品溶液-2024092211批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1597325-59732527.88727.8911.9227.8927.8911.92
2619574-61957428.92628.93
3663381-66338130.97130.97
4607068-60706828.34228.34
5636447-63644729.71329.71
6460127-46012721.48221.48
10min11267588-126758859.17960.944.6159.2461.004.62
21385431-138543164.68164.74
31308808-130880861.10361.17
41313413-131341361.31861.38
51344313-134431362.76162.83
61212271-121227156.59756.64
15min11545783-154578372.16774.352.5772.3674.542.57
21656469-165646977.33477.54
31565523-156552373.08973.29
41606333-160633374.99475.19
51614299-161429975.36675.57
61566855-156685573.15173.32
20min11674284-167428478.16680.362.0078.5280.722.01
21772857-177285782.76883.15
31696791-169679179.21779.58
41734266-173426680.96781.33
51735835-173583581.04081.41
61713678-171367880.00580.34
30min11808930-180893084.45286.641.7184.9887.181.71
21905254-190525488.94989.51
31838406-183840685.82886.37
41861254-186125486.89587.44
51862050-186205086.93287.49
61858465-185846586.76587.28
45min11895140-189514088.47790.811.6689.1991.541.67
21994183-199418393.10193.86
31930865-193086590.14590.88
41946816-194681690.89091.63
51952979-195297991.17791.92
61951013-195101391.08691.79
60min11933566-193356690.27192.611.7391.1893.541.74
22038331-203833195.16296.13
31966538-196653891.81092.74
41987626-198762692.79593.74
51992389-199238993.01793.97
61983559-198355992.60593.51
极限11960169-196016991.51393.711.6392.6394.851.63
22061811-206181196.25897.44
31997891-199789193.27494.41
42008678-200867893.77894.92
52011920-201192093.92995.08
62002781-200278193.50394.62
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