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%
115.221738191742761738431733471728191736210.33
215.251737301730651733980.28
单位质量响应值RSD%判断
11407.4211370.360.24数据可信
供试品溶液-25052601-1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%
30min123773-2377312.45912.323.5012.4612.323.49
224279-2427912.72412.72
322622-2262211.85611.86
424425-2442512.80112.80
523500-2350012.31612.32
622466-2246611.77411.77
60min143363-4336322.72623.175.0622.7523.205.06
248496-4849625.41625.44
342698-4269822.37822.40
444778-4477823.46823.49
543308-4330822.69722.72
642648-4264822.35122.37
120min174515-7451539.05338.892.0939.1138.952.09
276085-7608539.87539.94
373020-7302038.26938.33
475265-7526539.44639.51
574484-7448439.03639.09
671820-7182037.64037.70
240min1121373-12137363.61063.041.8163.7363.161.81
2122835-12283564.37764.51
3119621-11962162.69262.81
4120741-12074163.27963.41
5120735-12073563.27663.40
6116407-11640761.00861.13
360min1149139-14913978.16277.411.2478.3977.631.24
2149029-14902978.10578.34
3148517-14851777.83678.06
4148527-14852777.84278.07
5146389-14638976.72176.95
6144570-14457075.76875.99
480min1165232-16523286.59785.791.2286.9686.151.23
2165030-16503086.49186.86
3165186-16518686.57286.93
4164149-16414986.02986.39
5162174-16217484.99485.35
6160381-16038184.05484.40
600min1175359-17535991.90490.831.2492.4191.331.24
2173907-17390791.14391.65
3175116-17511691.77792.28
4174158-17415891.27591.78
5170681-17068189.45289.95
6170607-17060789.41489.90
720min1180283-18028394.48593.601.1495.1494.251.14
2179391-17939194.01794.68
3180328-18032894.50895.16
4179399-17939994.02194.68
5175520-17552091.98892.64
6176623-17662392.56793.20
960min1185789-18578997.37096.041.3698.1996.851.36
2183553-18355396.19897.02
3185719-18571997.33498.14
4183846-18384696.35297.17
5179716-17971694.18894.99
6180927-18092794.82295.61
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186982-18698297.99696.741.2498.9797.711.24
2184815-18481596.86097.84
3186552-18655297.77098.74
4185421-18542197.17798.15
5181152-18115294.94095.90
6182585-18258595.69196.64
1440min1187772-18777298.41096.911.3799.5598.041.37
2184881-18488196.89498.04
3187247-18724798.13499.27
4185354-18535497.14298.28
5181005-18100594.86395.98
6183233-18323396.03197.14
极限1187254-18725498.13896.781.4599.4498.071.45
2185035-18503596.97598.28
3187332-18733298.17999.48
4185307-18530797.11898.42
5180611-18061194.65795.93
6182455-18245595.62396.89
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%
115.221739031731501732341731531733941733670.19
215.251735091731771733430.14
单位质量响应值RSD%判断
11390.7411366.750.15数据可信
供试品溶液-25052601-2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%
30min121377-2137711.21311.823.4511.2111.823.46
222032-2203211.55711.56
322428-2242811.76511.76
423372-2337212.26012.26
523372-2337212.26012.26
622593-2259311.85111.85
60min140880-4088021.44422.222.3421.4622.242.34
242005-4200522.03422.05
342546-4254622.31822.34
443254-4325422.68922.71
543579-4357922.86022.88
641874-4187421.96521.99
120min169931-6993136.68337.582.0736.7437.632.07
270934-7093437.20937.26
371012-7101237.25037.31
473571-7357138.59238.65
573366-7336638.48538.54
670998-7099837.24337.30
240min1113430-11343059.50160.451.5559.6260.571.56
2113931-11393159.76359.88
3113507-11350759.54159.66
4116660-11666061.19561.32
5117250-11725061.50461.63
6116618-11661861.17361.29
360min1139814-13981473.34073.601.0873.5673.821.08
2138399-13839972.59872.82
3139332-13933273.08873.31
4140309-14030973.60073.82
5142584-14258474.79475.02
6141445-14144574.19674.42
480min1154527-15452781.05881.350.9881.4081.690.98
2153748-15374880.65080.99
3154465-15446581.02681.37
4154026-15402680.79681.14
5157778-15777882.76483.11
6155907-15590781.78282.13
600min1164088-16408886.07486.060.8486.5586.540.84
2162602-16260285.29485.77
3163019-16301985.51385.99
4163406-16340685.71686.20
5166304-16630487.23687.72
6164961-16496186.53287.01
720min1168433-16843388.35388.430.9988.9789.060.99
2167134-16713487.67188.29
3167129-16712987.66988.29
4167647-16764787.94188.57
5171109-17110989.75790.39
6170078-17007889.21689.84
960min1173624-17362491.07690.870.9991.8491.640.98
2171258-17125889.83590.60
3172077-17207790.26491.03
4172173-17217390.31591.09
5175720-17572092.17592.96
6174548-17454891.56092.33
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1175249-17524991.92892.211.8292.8493.131.82
2173028-17302890.76391.67
3172464-17246490.46791.38
4174783-17478391.68492.61
5178560-17856093.66594.60
6180637-18063794.75595.68
1440min1176679-17667992.67892.231.4093.7593.301.40
2173713-17371391.12292.18
3173072-17307290.78691.85
4174523-17452391.54792.62
5179349-17934994.07995.17
6177632-17763293.17894.26
极限1174530-17453091.55191.891.2592.7793.121.24
2174037-17403791.29292.51
3172411-17241190.43991.66
4174600-17460091.58892.81
5178367-17836793.56494.81
6177151-17715192.92694.16
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