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%
116.611355641352701352141354491354751353940.11
216.601347121351631349380.24
单位质量响应值RSD%判断
8151.358128.800.20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
20250509211135381-13538199.6999.571.1198.42%~100.72%
2133730-13373098.47
3136698-136698100.66
4133489-13348998.30
5134921-13492199.35
6137110-137110100.96
20250510211137057-137057100.92100.421.0699.30%~101.53%
2138227-138227101.78
3136789-136789100.73
4134004-13400498.67
5135585-13558599.84
6136567-136567100.56
20250511211137452-137452101.21101.541.21100.26%~102.83%
2137038-137038100.91
3138637-138637102.09
4135353-13535399.67
5140161-140161103.21
6138749-138749102.17
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%
116.612738862735822738012741082739742738700.08
216.602721822720852721340.03
单位质量响应值RSD%判断
16488.2616393.610.41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
20250509211273577-27357799.7499.250.5598.68%~99.81%
2271652-27165299.04
3269730-26973098.34
4271753-27175399.08
5273543-27354399.73
6273053-27305399.55
20250510211266147-26614797.0397.861.2696.57%~99.15%
2272671-27267199.41
3270701-27070198.69
4270530-27053098.63
5263912-26391296.22
6266494-26649497.16
20250511211269320-26932098.1998.281.1197.15%~99.42%
2266947-26694797.32
3265851-26585196.92
4271236-27123698.89
5270129-27012998.48
6274046-27404699.91
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%
116.611332771331701334091332231331881332530.08
216.601336881338321337600.08
单位质量响应值RSD%判断
8022.468057.830.32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
20250509211135931-135931101.34100.701.1999.45%~101.95%
2134389-134389100.19
3133280-13328099.36
4137463-137463102.48
5135787-135787101.23
6133618-13361899.61
20250510211135914-135914101.33100.691.5899.02%~102.35%
2135918-135918101.33
3134030-13403099.92
4138455-138455103.22
5132720-13272098.94
6133300-13330099.38
20250511211135275-135275100.85100.381.9898.30%~102.45%
2136966-136966102.11
3132409-13240998.71
4136035-136035101.42
5136764-136764101.96
6130403-13040397.22
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%
116.612724172728142729842729682727952727960.09
216.602718772717612718190.04
单位质量响应值RSD%判断
16423.6016374.640.22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
20250509211271761-27176199.3398.940.9697.95%~99.93%
2269436-26943698.48
3270151-27015198.74
4271576-27157699.26
5266799-26679997.52
6274457-274457100.32
20250510211268008-26800897.9697.890.8597.02%~98.77%
2263820-26382096.43
3267236-26723697.68
4270055-27005598.71
5269941-26994198.67
6267881-26788197.91
20250511211267277-26727797.6998.231.2896.92%~99.55%
2271836-27183699.36
3268936-26893698.30
4266288-26628897.33
5273613-273613100.01
6264597-26459796.71
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