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%
115.061754351758271758161754821751691755460.16
215.101761871762721762300.04
单位质量响应值RSD%判断
11656.4411670.860.09数据可信
供试品溶液-1234026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%
30min128154-2815414.40813.763.8314.4113.763.83
227825-2782514.23914.24
326391-2639113.50513.51
426165-2616513.39013.39
527278-2727813.95913.96
625517-2551713.05813.06
60min147348-4734824.23023.763.1024.2523.783.09
248110-4811024.62024.64
345595-4559523.33323.36
445072-4507223.06523.09
547617-4761724.36824.39
644789-4478922.92022.94
120min176147-7614738.96837.923.3739.0337.983.37
277288-7728839.55239.62
373399-7339937.56137.62
471029-7102936.34936.41
575030-7503038.39638.46
671652-7165236.66736.73
240min1115300-11530059.00457.822.3459.1357.942.34
2116116-11611659.42259.55
3112729-11272957.68857.81
4109495-10949556.03356.15
5113862-11386258.26858.40
6110417-11041756.50556.63
360min1142335-14233572.83971.651.8573.0771.871.85
2142822-14282273.08873.32
3139818-13981871.55171.77
4137239-13723970.23170.45
5141119-14111972.21772.44
6136683-13668369.94770.16
480min1167387-16738785.65984.081.1686.0184.431.17
2165542-16554284.71585.07
3163732-16373283.78984.13
4162035-16203582.92083.25
5164106-16410683.98084.33
6163054-16305483.44283.77
600min1177832-17783291.00489.701.0991.5090.181.10
2176865-17686590.51091.00
3175528-17552889.82590.30
4173041-17304188.55389.02
5175151-17515189.63290.12
6173265-17326588.66789.14
720min1183991-18399194.15693.000.8594.8093.630.86
2182558-18255893.42394.07
3182280-18228093.28193.91
4179833-17983392.02892.65
5181361-18136192.81093.45
6180310-18031092.27392.89
960min1190260-19026097.36496.480.8098.1697.260.80
2188806-18880696.62097.42
3190331-19033197.40198.18
4187209-18720995.80396.57
5187478-18747895.94196.73
6187118-18711895.75696.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193016-19301698.77597.730.5899.7498.680.58
2190829-19082997.65698.62
3191290-19129097.89198.84
4190245-19024597.35798.29
5190219-19021997.34398.29
6190212-19021297.34098.27
1440min1193293-19329398.91798.490.69100.0499.600.68
2192023-19202398.26799.39
3192721-19272198.62499.73
4194441-19444199.504100.60
5191496-19149697.99799.11
6190786-19078697.63498.73
极限1192822-19282298.67598.120.4399.9799.400.44
2192419-19241998.46999.76
3192044-19204498.27799.55
4191100-19110097.79499.05
5191277-19127797.88599.16
6190758-19075897.61998.88
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%
115.061757431758341761911758851752381757780.20
215.101759461756801758130.11
单位质量响应值RSD%判断
11671.8511643.250.18数据可信
供试品溶液-1234026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%
30min125171-2517112.88813.392.0412.8913.392.05
226478-2647813.55713.56
326241-2624113.43613.44
426657-2665713.64913.65
526360-2636013.49713.50
625944-2594413.28413.28
60min144866-4486622.97223.742.8322.9923.762.84
246019-4601923.56223.58
346543-4654323.83123.85
448761-4876124.96624.99
545691-4569123.39423.42
646284-4628423.69823.72
120min172101-7210136.91737.961.5736.9838.021.57
274545-7454538.16838.23
375626-7562638.72138.78
473912-7391237.84437.91
574040-7404037.90937.97
674562-7456238.17738.24
240min1111054-11105456.86157.911.4056.9858.041.40
2112468-11246857.58557.71
3115872-11587259.32859.45
4112787-11278757.74857.88
5113440-11344058.08358.21
6112995-11299557.85557.98
360min1137065-13706570.17971.521.4170.4071.741.41
2138708-13870871.02071.24
3143053-14305373.24573.47
4139535-13953571.44471.67
5139801-13980171.58071.80
6139963-13996371.66371.88
480min1162482-16248283.19383.731.0583.5384.081.05
2162138-16213883.01783.36
3166748-16674885.37785.72
4164107-16410784.02584.37
5162731-16273183.32083.66
6163037-16303783.47783.82
600min1172336-17233688.23889.451.4088.7189.931.40
2172636-17263688.39288.87
3178994-17899491.64792.14
4175705-17570589.96390.45
5174508-17450889.35089.83
6173995-17399589.08889.57
720min1178621-17862191.45692.491.2792.0793.121.27
2178949-17894991.62492.25
3184958-18495894.70195.34
4180576-18057692.45793.09
5180008-18000892.16692.79
6180780-18078092.56293.19
960min1186491-18649195.48695.791.2196.2696.581.20
2184346-18434694.38795.17
3191208-19120897.90198.70
4186444-18644495.46296.25
5187034-18703495.76496.55
6187019-18701995.75696.54
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190400-19040097.48797.281.2898.4298.231.28
2187321-18732195.91196.85
3194499-19449999.586100.55
4189714-18971497.13698.08
5188949-18894996.74497.69
6189126-18912696.83597.78
1440min1193107-19310798.87398.141.3799.9799.251.37
2188863-18886396.70097.80
3196251-196251100.483101.61
4191027-19102797.80898.92
5190472-19047297.52498.63
6190383-19038397.47898.58
极限1191157-19115797.87597.761.2099.1399.021.20
2188427-18842796.47797.73
3195224-19522499.957101.25
4190296-19029697.43498.70
5190205-19020597.38798.65
6190245-19024597.40898.67
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