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101242-201201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(%)100.0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%
116.553979563971813978513978543978313977350.08
216.454003724004494004100.02
单位质量响应值RSD%判断
24032.3324341.030.91数据可信
供试品溶液-2K72SDB2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%
5min1290356-29035672.03272.363.0972.0372.363.09
2296445-29644573.54273.54
3277838-27783868.92668.93
4285065-28506570.71970.72
5301057-30105774.68674.69
6299265-29926574.24274.24
10min1373215-37321592.58793.041.2092.7193.161.20
2374136-37413692.81692.94
3368552-36855291.43191.55
4374108-37410892.80992.93
5381059-38105994.53394.66
6379197-37919794.07194.20
15min1395890-39589098.21398.600.8698.4998.880.86
2394825-39482597.94898.23
3393653-39365397.65897.92
4397675-39767598.65598.93
5402641-40264199.887100.17
6400028-40002899.23999.52
20min1402855-40285599.940100.010.78100.38100.450.78
2402366-40236699.819100.26
3398242-39824298.79699.23
4402321-40232199.808100.24
5407070-407070100.986101.43
6406064-406064100.737101.18
30min1406120-406120100.750100.600.73101.36101.210.73
2405312-405312100.550101.16
3400511-40051199.35999.95
4404479-404479100.343100.95
5408831-408831101.423102.04
6407915-407915101.196101.81
45min1404085-404085100.246100.470.67101.02101.240.67
2405001-405001100.473101.25
3401289-40128999.552100.31
4403567-403567100.117100.89
5408820-408820101.420102.21
6407137-407137101.003101.79
60min1403952-403952100.213100.350.69101.15101.280.69
2404895-404895100.447101.39
3400345-40034599.318100.24
4402836-40283699.936100.87
5407911-407911101.195102.15
6406979-406979100.964101.91
极限1403246-403246100.037100.230.65101.14101.340.65
2403654-403654100.139101.25
3401322-40132299.560100.65
4401696-40169699.653100.76
5407841-407841101.177102.30
6406436-406436100.829101.95
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101242-201201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(%)100.0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%
116.553995053997493991623988763990903992760.09
216.453992293995033993660.05
单位质量响应值RSD%判断
24125.4424277.570.45数据可信
供试品溶液-2K72SDB2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%
5min1294920-29492073.11773.442.1473.1273.442.14
2298126-29812673.91273.91
3297596-29759673.78073.78
4284860-28486070.62370.62
5303993-30399375.36675.37
6297958-29795873.87073.87
10min1385553-38555395.58794.280.9995.7194.400.99
2379758-37975894.15094.27
3378617-37861793.86793.99
4374388-37438892.81992.94
5382231-38223194.76394.89
6381197-38119794.50794.63
15min1403866-403866100.12799.630.51100.4199.910.51
2401913-40191399.64399.92
3400494-40049499.29199.57
4398657-39865798.83599.11
5403849-403849100.123100.41
6402359-40235999.753100.03
20min1409531-409531101.531101.030.41101.98101.480.41
2406078-406078100.675101.12
3407018-407018100.908101.35
4405721-405721100.587101.02
5409454-409454101.512101.96
6407291-407291100.976101.42
30min1410861-410861101.861101.540.36102.48102.150.36
2408763-408763101.341101.95
3409796-409796101.597102.21
4408092-408092101.175101.78
5411626-411626102.051102.67
6408214-408214101.205101.82
45min1410967-410967101.887101.420.47102.67102.200.47
2408232-408232101.209101.99
3409877-409877101.617102.40
4407003-407003100.905101.68
5411349-411349101.982102.77
6407072-407072100.922101.71
60min1409885-409885101.619101.280.63102.58102.230.63
2407304-407304100.979101.93
3410776-410776101.840102.79
4405989-405989100.653101.59
5411496-411496102.018102.98
6405612-405612100.560101.51
极限1408379-408379101.246101.080.59102.37102.200.58
2409078-409078101.419102.54
3407945-407945101.138102.26
4404928-404928100.390101.50
5410998-410998101.895103.02
6405033-405033100.416101.54
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101242-201201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(%)100.0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%
116.552005382009682004402002942005622005600.13
216.452001702000642001170.04
单位质量响应值RSD%判断
12118.4312165.170.28数据可信
供试品溶液-2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%
5min1169435-16943583.72888.014.7983.7388.014.79
2187467-18746792.63992.64
3176453-17645387.19687.20
4167119-16711982.58482.58
5182324-18232490.09890.10
6185768-18576891.80091.80
10min1205675-205675101.637101.651.10101.78101.801.10
2206859-206859102.222102.38
3205022-205022101.314101.46
4201734-20173499.68999.83
5208310-208310102.939103.09
6206643-206643102.115102.27
15min1206520-206520102.054102.201.10102.36102.521.11
2208713-208713103.138103.46
3206496-206496102.043102.36
4202737-202737100.185100.49
5209072-209072103.316103.64
6207347-207347102.463102.79
20min1206931-206931102.258102.271.16102.74102.761.16
2208583-208583103.074103.57
3206703-206703102.145102.63
4202788-202788100.210100.68
5209835-209835103.693104.19
6206936-206936102.260102.75
30min1206756-206756102.171102.371.20102.82103.031.20
2209008-209008103.284103.95
3206661-206661102.124102.78
4203035-203035100.332100.97
5210254-210254103.900104.57
6207224-207224102.402103.07
45min1207913-207913102.743103.101.36103.56103.921.36
2210585-210585104.063104.90
3208153-208153102.861103.69
4204288-204288100.951101.76
5212678-212678105.098105.94
6208147-208147102.858103.69
60min1208104-208104102.837102.991.24103.83103.991.24
2210047-210047103.797104.81
3207805-207805102.689103.69
4204148-204148100.882101.86
5211827-211827104.677105.69
6208512-208512103.039104.05
极限1207651-207651102.613102.881.32103.78104.051.32
2210011-210011103.780104.97
3206942-206942102.263103.43
4204233-204233100.924102.07
5212271-212271104.896106.09
6207990-207990102.781103.96
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