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%
1 16.584000944002713985774007363990793997510.23
2 16.534034344020944027640.24
单位质量响应值RSD%判断
24110.4324365.640.75数据可信
加速6月-供试品溶液-2025050421批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1387417-38741795.81095.170.9495.8195.170.94
2383592-38359294.86494.86
3389841-38984196.40996.41
4384365-38436595.05595.06
5379207-37920793.77993.78
6384590-38459095.11195.11
10min1404193-40419399.95999.660.57100.1299.810.57
2402406-40240699.51799.67
3406426-406426100.511100.67
4400601-40060199.07099.23
5400538-40053899.05599.21
6403650-40365099.82499.98
15min1404875-404875100.12799.830.67100.45100.150.66
2401907-40190799.39399.72
3408470-408470101.016101.34
4401575-40157599.31199.63
5401788-40178899.36499.69
6403410-40341099.765100.09
20min1404055-40405599.92499.760.42100.42100.250.42
2403034-40303499.672100.16
3406122-406122100.436100.93
4401950-40195099.40499.89
5401509-40150999.29599.78
6403729-40372999.844100.34
30min1404564-404564100.05099.590.34100.71100.250.35
2401935-40193599.400100.06
3404008-40400899.913100.58
4402317-40231799.495100.15
5400855-40085599.13399.79
6402476-40247699.534100.19
45min1404908-404908100.13599.440.47100.96100.270.47
2401593-40159399.316100.14
3403586-40358699.808100.64
4401907-40190799.393100.21
5399751-39975198.86099.68
6400939-40093999.15499.98
60min1403519-40351999.79299.210.45100.79100.200.45
2400554-40055499.059100.05
3403115-40311599.692100.69
4400496-40049699.044100.03
5398928-39892898.65799.64
6400457-40045799.035100.02
极限1402987-40298799.66099.050.44100.82100.210.44
2400666-40066699.086100.24
3402099-40209999.441100.60
4398937-39893798.65999.81
5398671-39867198.59399.74
6399816-39981698.876100.03
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%
1 16.584035314022264011364020244023094022450.22
2 16.534022163993894008020.50
单位质量响应值RSD%判断
24260.8624246.940.05数据可信
中间条件6月-供试品溶液-2025050421批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1325513-32551380.44687.378.9680.4587.378.96
2340739-34073984.20984.21
3388959-38895996.12696.13
4391052-39105296.64396.64
5316394-31639478.19278.19
6358522-35852288.60488.60
10min1388043-38804395.89999.632.2596.0399.782.26
2409945-409945101.312101.45
3409507-409507101.204101.36
4409881-409881101.296101.46
5396428-39642897.97198.10
6405126-405126100.121100.27
15min1400150-40015098.891101.021.1599.19101.341.16
2411569-411569101.713102.02
3410218-410218101.379101.71
4412599-412599101.968102.30
5406758-406758100.524100.82
6411383-411383101.667101.98
20min1401520-40152099.230101.010.9499.69101.490.94
2412174-412174101.863102.34
3408210-408210100.883101.38
4410813-410813101.526102.03
5408877-408877101.048101.51
6410828-410828101.530102.01
30min1400183-40018398.899100.981.0599.52101.621.05
2412319-412319101.899102.55
3409147-409147101.115101.78
4409916-409916101.305101.97
5410504-410504101.450102.08
6409475-409475101.196101.85
45min1400499-40049998.978100.730.9199.77101.540.91
2410422-410422101.430102.25
3408070-408070100.849101.68
4410101-410101101.351102.19
5409314-409314101.156101.95
6407037-407037100.593101.42
60min1402603-40260399.498101.702.57100.45102.682.56
2414028-414028102.321103.31
3406722-406722100.515101.52
4431635-431635106.672107.68
5405672-405672100.256101.22
6408335-408335100.914101.90
极限1403509-40350999.721100.191.26100.84101.341.26
2408134-408134100.864102.02
3407498-407498100.707101.88
4410951-410951101.561102.75
5406004-406004100.338101.47
6396254-39625497.92899.09
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%
1 16.583977233985554007753975493998823988970.36
2 16.533989963966753978360.42
单位质量响应值RSD%判断
24058.9324067.510.03数据可信
加速6月-供试品溶液-2025050621批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1390258-39025897.21196.140.7397.2196.140.73
2387674-38767496.56796.57
3384200-38420095.70295.70
4384856-38485695.86595.87
5382289-38228995.22695.23
6386371-38637196.24396.24
10min1408596-408596101.779100.180.86101.94100.340.86
2398916-39891699.36899.53
3401744-401744100.072100.23
4402660-402660100.300100.46
5401620-401620100.041100.20
6399630-39963099.54599.71
15min1405950-405950101.120100.020.70101.45100.340.70
2398462-39846299.25499.58
3400284-40028499.708100.03
4403284-403284100.456100.78
5401986-401986100.132100.46
6399214-39921499.44299.77
20min1406413-406413101.23599.960.79101.74100.450.79
2398664-39866499.30599.80
3400245-40024599.699100.19
4403481-403481100.505101.00
5400826-40082699.843100.34
6398032-39803299.14799.64
30min1406637-406637101.29199.920.88101.96100.580.87
2398731-39873199.32199.98
3399588-39958899.535100.19
4403391-403391100.482101.14
5401554-401554100.025100.68
6396968-39696898.88299.54
45min1405699-405699101.05799.750.76101.89100.580.76
2397974-39797499.13399.96
3398614-39861499.292100.12
4402328-402328100.217101.05
5400040-40004099.648100.47
6398097-39809799.16499.99
60min1406036-406036101.14199.620.89102.15100.610.88
2396443-39644398.75299.74
3397690-39769099.062100.05
4401849-401849100.098101.09
5398004-39800499.140100.13
6399447-39944799.500100.49
极限1405962-405962101.123100.412.61102.30101.572.58
2393734-39373498.07799.23
3398884-39888499.360100.51
4422958-422958105.356106.52
5398419-39841999.244100.40
6398625-39862599.295100.45
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%
1 16.583987703959493986793991683967223978580.36
2 16.534079384022564050971.00
单位质量响应值RSD%判断
23996.2624506.781.49数据可信
中间条件6月-供试品溶液-2025050621批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1345375-34537585.37293.535.7185.3793.535.71
2398273-39827398.44898.45
3389601-38960196.30496.30
4360726-36072689.16789.17
5398515-39851598.50898.51
6377754-37775493.37693.38
10min1406978-406978100.600101.380.94100.74101.540.94
2417160-417160103.117103.28
3410527-410527101.477101.64
4407276-407276100.673100.82
5411006-411006101.595101.76
6407927-407927100.834100.99
15min1409229-409229101.156101.400.46101.47101.730.46
2413349-413349102.175102.51
3411078-411078101.613101.94
4410189-410189101.393101.71
5409732-409732101.280101.61
6407822-407822100.808101.13
20min1408964-408964101.091101.230.42101.57101.720.43
2412309-412309101.917102.42
3410466-410466101.462101.96
4408796-408796101.049101.53
5409362-409362101.189101.69
6407231-407231100.662101.15
30min1408419-408419100.956101.030.43101.60101.690.44
2409227-409227101.156101.83
3409092-409092101.122101.79
4408815-408815101.054101.71
5411062-411062101.609102.28
6405666-405666100.275100.93
45min1408707-408707101.027100.820.47101.84101.650.47
2410429-410429101.453102.30
3408124-408124100.883101.72
4406835-406835100.564101.39
5408285-408285100.923101.76
6404801-404801100.062100.89
60min1406280-406280100.427100.420.48101.41101.410.48
2408368-408368100.943101.96
3405518-405518100.239101.24
4404565-404565100.003100.99
5408638-408638101.010102.02
6404029-40402999.871100.86
极限1405935-405935100.342100.290.69101.49101.450.69
2406600-406600100.506101.69
3405011-405011100.114101.29
4403529-40352999.747100.90
5410533-410533101.478102.66
6402643-40264399.528100.69
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