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%
115.041753301755371755361754591752571754240.08
215.161751551754431752990.12
单位质量响应值RSD%判断
11663.8311563.260.62数据可信
供试品溶液-2025032321批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min135055-3505518.01717.904.1718.0217.904.17
234282-3428217.62017.62
337433-3743319.23919.24
435099-3509918.04018.04
533563-3356317.25017.25
633525-3352517.23117.23
60min160346-6034631.01630.883.2431.0530.913.23
259065-5906530.35730.39
363570-6357032.67332.70
460600-6060031.14631.18
558636-5863630.13730.17
658287-5828729.95729.99
120min195166-9516648.91248.861.6148.9948.941.61
294462-9446248.55048.63
397526-9752650.12550.21
495944-9594449.31249.39
593202-9320247.90247.98
694116-9411648.37248.45
240min1143464-14346473.73573.810.9773.9073.980.98
2143215-14321573.60773.77
3145411-14541174.73674.91
4144545-14454574.29174.45
5141291-14129172.61872.78
6143749-14374973.88174.04
360min1168758-16875886.73587.591.0087.0287.881.00
2172197-17219788.50388.79
3171149-17114987.96488.26
4171826-17182688.31288.60
5168015-16801586.35386.63
6170624-17062487.69487.98
480min1184477-18447794.81495.380.8795.2495.810.87
2186596-18659695.90396.33
3186464-18646495.83596.28
4187669-18766996.45596.89
5183287-18328794.20294.63
6184980-18498095.07395.50
600min1191214-19121498.27799.301.0998.8799.901.09
2195653-195653100.558101.15
3192865-19286599.12599.73
4195666-195666100.565101.16
5190762-19076298.04498.63
6193108-19310899.25099.84
720min1197776-197776101.649101.300.94102.40102.060.94
2198715-198715102.132102.89
3195763-195763100.615101.38
4199422-199422102.495103.26
5194589-194589100.011100.76
6196372-196372100.928101.68
960min1198805-198805102.178100.541.68103.10101.471.66
2193510-19351099.457100.39
3194707-194707100.072101.01
4194633-194633100.034100.97
5191742-19174298.54899.46
6200325-200325102.959103.88
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1203005-203005104.337102.071.39105.43103.171.37
2197215-197215101.361102.46
3197637-197637101.578102.68
4197646-197646101.582102.68
5200677-200677103.140104.22
6195419-195419100.438101.53
1440min1199792-199792102.685100.721.42103.95101.981.41
2198830-198830102.191103.45
3195194-195194100.322101.59
4195515-195515100.487101.76
5193646-19364699.527100.77
6192855-19285599.120100.38
极限1198926-198926102.240100.591.56103.68102.021.54
2198912-198912102.233103.67
3195613-195613100.538101.97
4195414-195414100.435101.87
5194702-194702100.069101.48
6190770-19077098.04899.47
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%
115.041749611748191748961749581750971749460.06
215.161758901760501759700.07
单位质量响应值RSD%判断
11632.0511607.520.15数据可信
供试品溶液-2025032321批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min135910-3591018.44618.241.0118.4518.241.01
234940-3494017.94817.95
335675-3567518.32518.33
435395-3539518.18218.18
535798-3579818.38918.39
635348-3534818.15718.16
60min162216-6221631.95931.341.5031.9931.371.49
260875-6087531.27031.30
361038-6103831.35431.38
459562-5956230.59630.63
560653-6065331.15631.19
661681-6168131.68431.71
120min199461-9946151.09149.291.8351.1749.371.82
295714-9571449.16649.25
395405-9540549.00749.09
494815-9481548.70448.79
595276-9527648.94149.02
695041-9504148.82048.90
240min1146891-14689175.45473.801.1975.6273.971.19
2144114-14411474.02874.19
3142954-14295473.43273.60
4143031-14303173.47273.63
5142040-14204072.96373.13
6143042-14304273.47773.64
360min1173125-17312588.93087.371.0889.2387.661.08
2171039-17103987.85988.15
3169854-16985487.25087.54
4169920-16992087.28487.57
5168627-16862786.62086.91
6167977-16797786.28686.57
480min1188455-18845596.80594.441.7297.2594.871.72
2186064-18606495.57796.01
3183267-18326794.14094.57
4183809-18380994.41894.85
5179292-17929292.09892.53
6182197-18219793.59094.02
600min1195696-195696100.52498.241.83101.1398.831.83
2194635-19463599.979100.57
3189710-18971097.45098.04
4191837-19183798.54299.13
5186489-18648995.79596.38
6189155-18915597.16497.75
720min1199428-199428102.441100.061.73103.21100.821.72
2196982-196982101.185101.94
3192916-19291699.09699.85
4194770-194770100.049100.80
5189664-18966497.42698.17
6195023-195023100.179100.93
960min1201320-201320103.413100.172.03104.36101.102.03
2197128-197128101.260102.19
3192833-19283399.05499.97
4195808-195808100.582101.50
5190142-19014297.67198.58
6192829-19282999.05299.97
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1204219-204219104.902101.292.22106.02102.382.21
2199121-199121102.284103.38
3194611-19461199.967101.05
4198412-198412101.920103.01
5191814-19181498.53099.60
6194997-194997100.165101.25
1440min1201174-201174103.338100.242.09104.63101.502.09
2197649-197649101.528102.80
3193243-19324399.264100.51
4196423-196423100.898102.15
5189788-18978897.49098.72
6192606-19260698.937100.18
极限1200994-200994103.246100.301.89104.71101.731.89
2197320-197320101.359102.80
3193728-19372899.513100.93
4196223-196223100.795102.22
5190787-19078798.00399.40
6192502-19250298.884100.30
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