托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
116.611343151341201343431339781341041341720.12
216.601349411349611349510.02
单位质量响应值RSD%判断
8077.788129.580.46数据可信
中间条件9月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025050921113317513384013350898.7598.720.8497.85%～99.58%
213265513252213258898.07
313504113462213483299.73
413242913235113239097.93
513277113255013266098.12
613463313496813480099.71
20250510211134988135433135210100.01100.590.9999.55%～101.63%
2137907137790137848101.96
3136168136701136434100.92
413380413425013402799.14
5135474135657135566100.27
6136762136917136840101.22
20250511211137231137149137190101.48101.891.19100.62%～103.16%
2137025136915136970101.31
3138552138417138484102.43
4135106135472135289100.07
5140081139993140037103.58
6138552138553138552102.48
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
116.611329701329081327481331381328631329250.11
216.601334261336131335200.10
单位质量响应值RSD%判断
8002.718043.370.36数据可信
长期9月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025050921113293213292213292799.3198.991.2897.66%～100.32%
213242913243113243098.94
313112613102313107497.93
4135384135533135458101.20
513240713244713242798.94
613066913066213066697.62
20250510211135299135581135440101.19100.161.2398.88%～101.45%
2134448134711134580100.55
313329013326113327699.57
4136059136109136084101.67
513166513148513157598.30
613321613370513346099.71
20250511211135169135222135196101.01100.952.4698.35%～103.55%
2135077135279135178100.99
313245213300713273099.16
4140125140119140122104.69
5136996136855136926102.30
613064413046713055697.54
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
116.612711312706882706732712222708682709160.10
216.602723312725482724400.06
单位质量响应值RSD%判断
16310.4216412.050.44数据可信
中间条件9月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025050921126706826685726696297.8097.920.4897.42%～98.41%
226718126673026695697.80
326513626495626504697.10
426766426791226778898.11
526827026858326842698.34
626863826823126843498.34
2025051021126487126504226495697.0797.861.2996.54%～99.18%
227121827165527143699.44
326982827008026995498.90
426884226928226906298.57
526354126333126343696.51
626415826368926392496.69
2025051121126847926844326846198.3598.040.6997.34%～98.75%
226702426693326697897.81
326402826473226438096.86
426963926972426968298.80
526886026841626863898.42
626769326742426755898.02
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品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1000
标示量(mg)15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%
116.612716742723672723422723372722322721900.11
216.602705962705502705730.02
单位质量响应值RSD%判断
16387.1216299.580.38数据可信
长期9月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025050921126550326536026543297.3597.831.3196.49%～99.17%
226264826260426262696.32
326793026777626785398.24
426830626871426851098.48
526404426367826386196.77
627241027190127215699.82
2025051021126673926674226674097.8397.940.9097.03%～98.86%
226312026330426321296.53
326634526630026632297.68
427046227021327033899.15
526843226855026849198.47
626750426692026721298.00
2025051121126710226785226747798.1098.080.8397.22%～98.93%
226839926829026834498.42
326760226787926774098.20
426660126627426643897.72
527040927074627057899.24
626391926383726387896.78
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