乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
114.721712211711381714951716101710061712940.15
214.771711691713391712540.08
单位质量响应值RSD%判断
11636.8211594.720.26数据可信
供试品溶液-bc1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min1163055-16305583.78782.084.4583.7982.084.45
2167069-16706985.84985.85
3151811-15181178.00978.01
4165210-16521084.89484.89
5150096-15009677.12877.13
6161130-16113082.79782.80
60min1175726-17572690.29890.492.4690.4490.632.47
2178334-17833491.63891.78
3168470-16847086.56986.70
4181560-18156093.29593.44
5175757-17575790.31490.44
6176794-17679490.84690.98
120min1182623-18262393.84295.102.1294.1395.392.12
2184201-18420194.65394.95
3179392-17939292.18192.46
4190686-19068697.98598.28
5187347-18734796.26996.55
6186183-18618395.67195.96
240min1184323-18432394.71596.541.9995.1696.991.99
2185195-18519595.16395.62
3184485-18448594.79995.23
4193274-19327499.31599.78
5190185-19018597.72798.17
6189756-18975697.50797.96
360min1190245-19024597.75899.821.9698.36100.431.95
2191218-19121898.25898.87
3191573-19157398.44199.03
4199665-199665102.599103.22
5197042-197042101.251101.85
6195814-195814100.620101.23
480min1190341-19034197.80899.601.7998.57100.371.78
2190738-19073898.01298.79
3191427-19142798.36699.12
4198647-198647102.076102.87
5196359-196359100.900101.67
6195449-195449100.432101.21
600min1189803-18980397.53199.161.8098.46100.101.80
2190001-19000197.63398.57
3190407-19040797.84298.76
4197911-197911101.698102.66
5196091-196091100.762101.70
6193677-19367799.522100.47
720min1188690-18869096.95998.761.7998.0599.871.79
2188938-18893897.08798.19
3190187-19018797.72998.81
4196865-196865101.160102.30
5195192-195192100.300101.41
6193315-19331599.336100.45
960min1186356-18635695.76097.821.9697.0199.091.95
2187263-18726396.22697.49
3188110-18811096.66197.90
4195444-195444100.430101.73
5193782-19378299.576100.85
6191219-19121998.25999.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1186559-18655995.86497.641.7997.2899.071.79
2187429-18742996.31197.74
3187602-18760296.40097.80
4194880-194880100.140101.61
5193088-19308899.219100.66
6190476-19047697.87799.32
1440min1185917-18591795.53497.431.7797.1199.021.76
2186665-18666595.91997.50
3187730-18773096.46698.03
4193984-19398499.680101.32
5192765-19276599.053100.66
6190536-19053697.90899.51
极限1185643-18564395.39497.401.7997.1399.161.79
2187299-18729996.24497.99
3186875-18687596.02797.75
4193467-19346799.414101.22
5193100-19310099.225101.00
6190928-19092898.10999.88
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
114.721718941713771718921717871721661718230.17
214.771715181714931715060.02
单位质量响应值RSD%判断
11672.7611611.780.38数据可信
供试品溶液-bc2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min128646-2864614.68615.374.6914.6915.374.67
228176-2817614.44514.45
330039-3003915.40115.40
430923-3092315.85415.85
531955-3195516.38316.38
630134-3013415.44915.45
60min153269-5326927.31027.874.9527.3327.904.94
251424-5142426.36426.39
353202-5320227.27627.30
457314-5731429.38429.41
558098-5809829.78629.81
652872-5287227.10727.13
120min186324-8632444.25744.412.6144.3344.482.62
283184-8318442.64742.72
386162-8616244.17444.25
488616-8861645.43245.51
589589-8958945.93146.01
685823-8582344.00044.07
240min1125773-12577364.48264.532.4764.6364.682.47
2121581-12158162.33362.47
3126813-12681365.01565.16
4127151-12715165.18965.34
5130456-13045666.88367.04
6123421-12342163.27663.42
360min1154344-15434479.13078.352.0179.3878.602.01
2147818-14781875.78476.03
3155378-15537879.66079.91
4154409-15440979.16379.42
5154754-15475479.34079.61
6150250-15025077.03177.28
480min1169928-16992887.12085.612.0987.5086.002.09
2161452-16145282.77483.14
3169992-16999287.15387.54
4168067-16806786.16686.56
5168510-16851086.39386.79
6163998-16399884.08084.46
600min1181060-18106092.82790.172.3293.3690.702.32
2170937-17093787.63788.14
3177986-17798691.25191.78
4177495-17749590.99991.53
5176796-17679690.64191.18
6171015-17101587.67788.20
720min1186007-18600795.36393.201.6896.0593.881.68
2179364-17936491.95892.61
3182707-18270793.67294.35
4183190-18319093.91994.61
5182133-18213393.37794.07
6177366-17736690.93391.60
960min1191937-19193798.40495.841.8699.2596.671.86
2183113-18311393.88094.69
3188426-18842696.60497.44
4188555-18855596.67097.51
5186612-18661295.67496.52
6182978-18297893.81094.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1195895-195895100.43397.681.91101.4498.671.91
2186957-18695795.85096.81
3191819-19181998.34399.34
4192119-19211998.49799.50
5190331-19033197.58098.59
6186041-18604195.38196.35
1440min1197287-197287101.14698.801.64102.3299.951.64
2192565-19256598.72699.85
3192677-19267798.78399.95
4194200-19420099.564100.73
5191904-19190498.38799.56
6187604-18760496.18297.31
极限1197502-197502101.25798.431.89102.6099.751.89
2188002-18800296.38697.67
3192926-19292698.911100.24
4193425-19342599.166100.50
5192144-19214498.51099.84
6187946-18794696.35797.65
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