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2000
标示量(mg)7.5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%
116.483979383978983977473977103971723976930.08
216.553988643995103991870.12
单位质量响应值RSD%判断
24131.8624120.060.04数据可信
供试品溶液-2025050821批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338714-33871484.15287.823.3484.1587.823.35
2355819-35581988.40288.40
3354349-35434988.03788.04
4368639-36863991.58791.59
5362464-36246490.05390.05
6340773-34077384.66484.66
10min1388875-38887596.61497.571.3196.7597.711.31
2398578-39857899.02599.17
3392872-39287297.60897.75
4399272-39927299.19899.35
5388859-38885996.61196.76
6387786-38778696.34496.49
15min1392642-39264297.55098.231.3597.8598.541.35
2402673-402673100.043100.35
3395406-39540698.23798.55
4400718-40071899.55799.87
5389038-38903896.65596.97
6391840-39184097.35197.65
20min1394156-39415697.92798.481.3698.3998.951.36
2401645-40164599.787100.27
3400120-40012099.40899.88
4401183-40118399.672100.16
5388821-38882196.60197.07
6392264-39226497.45697.92
30min1394965-39496598.12898.581.2798.7599.221.27
2402297-40229799.949100.59
3397196-39719698.68299.32
4403015-403015100.128100.78
5391068-39106897.15997.79
6392256-39225697.45498.08
45min1393776-39377697.83298.451.3598.6299.251.35
2401503-40150399.752100.56
3395409-39540998.23899.04
4403919-403919100.352101.17
5390073-39007396.91297.71
6392967-39296797.63198.42
60min1392738-39273897.57498.351.5598.5399.321.55
2401264-40126499.692100.67
3395855-39585598.34999.32
4404609-404609100.524101.51
5387950-38795096.38597.34
6392773-39277397.58398.53
极限1394688-39468898.05998.411.4599.1799.541.45
2401374-40137499.720100.86
3394818-39481898.09199.22
4404403-404403100.472101.62
5389129-38912996.67897.79
6392171-39217197.43398.55
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2000
标示量(mg)7.5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%
116.483994813998913997823995043993803996080.06
216.553988483995013991740.12
单位质量响应值RSD%判断
24248.0624119.270.38数据可信
供试品溶液-2025050821批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1355763-35576388.17883.156.3588.1883.156.35
2363511-36351190.09890.10
3313780-31378077.77277.77
4325032-32503280.56180.56
5340686-34068684.44184.44
6314002-31400277.82777.83
10min1398969-39896998.88697.241.6299.0397.381.62
2391494-39149497.03497.18
3381802-38180294.63294.76
4389589-38958996.56296.70
5393846-39384697.61797.76
6398223-39822398.70298.83
15min1399080-39908098.91498.060.9399.2398.360.93
2393200-39320097.45797.77
3391653-39165397.07397.36
4392898-39289897.38297.68
5396199-39619998.20098.50
6400756-40075699.32999.62
20min1398744-39874498.83198.000.9899.3198.460.98
2393047-39304797.41997.89
3391341-39134196.99697.44
4392366-39236697.25097.71
5395887-39588798.12398.59
6401003-40100399.39199.85
30min1398402-39840298.74698.030.9899.3998.660.98
2392766-39276697.34997.99
3392644-39264497.31997.93
4391643-39164397.07197.69
5396249-39624998.21298.84
6401402-40140299.489100.11
45min1397626-39762698.55497.950.9199.3698.740.91
2393655-39365597.56998.37
3392223-39222397.21497.99
4391007-39100796.91397.69
5395947-39594798.13798.93
6400609-40060999.293100.08
60min1396944-39694498.38597.821.0899.3598.771.07
2391216-39121696.96597.93
3391319-39131996.99097.93
4390993-39099396.91097.85
5396014-39601498.15499.11
6401468-40146899.506100.46
极限1396996-39699698.39797.700.8699.5398.820.86
2392197-39219797.20898.33
3392955-39295597.39698.49
4389567-38956796.55697.66
5394420-39442097.75998.88
6398919-39891998.874100.00
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