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%
110.151967057196800219691931968441196894219683270.05
210.191930198192995019300740.01
单位质量响应值RSD%判断
193923.84189408.641.67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%
5min1582950-58295027.37727.936.0227.3827.936.02
2589434-58943427.68227.68
3582936-58293627.37727.38
4647556-64755630.41130.41
5543728-54372825.53525.54
6621279-62127929.17729.18
10min11333132-133313262.60862.542.1962.6762.602.19
21275803-127580359.91659.98
31347846-134784663.29963.36
41341514-134151463.00263.07
51359368-135936863.84063.90
61331818-133181862.54662.61
15min11623104-162310476.22676.241.0776.4376.441.07
21624306-162430676.28376.48
31636656-163665676.86377.06
41626818-162681876.40076.61
51638577-163857776.95377.15
61590557-159055774.69874.90
20min11749820-174982082.17782.501.2882.5582.871.27
21781428-178142883.66184.03
31764792-176479282.88083.25
41754263-175426382.38682.76
51771900-177190083.21483.58
61717535-171753580.66181.03
30min11878937-187893788.24188.901.3388.7989.451.33
21926768-192676890.48791.04
31904672-190467289.44990.01
41886849-188684988.61289.17
51905780-190578089.50190.06
61854429-185442987.09087.64
45min11971891-197189192.60693.341.4393.3594.091.42
22022166-202216694.96795.72
32007363-200736394.27295.03
41973565-197356592.68593.44
52003690-200369094.10094.85
61946206-194620691.40092.14
60min12017275-201727594.73895.471.2895.6996.421.27
22067811-206781197.11198.07
32048499-204849996.20497.17
42016929-201692994.72195.68
52047478-204747896.15697.12
61998669-199866993.86494.81
极限12046634-204663496.11696.881.5297.2898.051.51
22100571-210057198.64999.83
32093702-209370298.32799.51
42035730-203573095.60496.78
52074590-207459097.42998.61
62026151-202615195.15496.31
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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