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500
标示量(mg)30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%
115.043396003440803454183452273450413438730.72
215.163448573451513450040.07
单位质量响应值RSD%判断
22863.9022757.520.33数据可信
供试品溶液-1236043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%
30min169066-6906618.07217.762.4018.0717.762.41
268132-6813217.82817.83
365863-6586317.23417.23
467399-6739917.63617.64
566501-6650117.40117.40
670223-7022318.37518.38
60min1115595-11559530.24829.771.7430.2829.801.75
2115220-11522030.14930.18
3110988-11098829.04229.07
4112944-11294429.55429.58
5112246-11224629.37129.40
6115591-11559130.24630.28
120min1183876-18387648.11446.771.5048.1946.851.50
2178600-17860046.73446.81
3176747-17674746.24946.33
4178181-17818146.62446.70
5176503-17650346.18546.26
6178582-17858246.72946.81
240min1280203-28020373.32071.831.2773.4871.991.27
2273852-27385271.65871.82
3276484-27648472.34772.50
4272516-27251671.30971.47
5270094-27009470.67570.83
6274001-27400171.69771.86
360min1337138-33713888.21886.651.2188.5086.931.21
2331557-33155786.75887.04
3334351-33435187.48987.76
4328764-32876486.02786.30
5326734-32673485.49685.77
6328370-32837085.92486.20
480min1367692-36769296.21394.761.2796.6495.191.26
2360550-36055094.34494.77
3368173-36817396.33996.76
4360024-36002494.20794.63
5358501-35850193.80894.22
6357988-35798893.67494.10
600min1382314-382314100.03998.471.37100.6399.051.36
2372520-37252097.47798.06
3383304-383304100.298100.88
4374317-37431797.94798.52
5371630-37163097.24497.82
6373797-37379797.81198.39
720min1385839-385839100.96299.841.37101.72100.581.37
2378962-37896299.16299.90
3390083-390083102.072102.82
4376652-37665298.55899.30
5378792-37879299.11899.85
6379003-37900399.17399.91
960min1386577-386577101.15599.781.43102.08100.691.42
2383650-383650100.389101.30
3387930-387930101.509102.43
4377565-37756598.79799.70
5377118-37711898.68099.58
6375127-37512798.15999.06
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1384822-384822100.696100.451.41101.79101.521.40
2385696-385696100.924102.00
3393404-393404102.941104.03
4379791-37979199.379100.45
5379785-37978599.378100.44
6379776-37977699.375100.44
1440min1385408-385408100.84999.801.27102.11101.051.27
2381982-38198299.952101.19
3388580-388580101.679102.94
4376406-37640698.49399.73
5377217-37721798.70699.93
6378902-37890299.147100.38
极限1383033-383033100.22799.571.57101.66100.981.56
2377423-37742398.760100.17
3391120-391120102.344103.77
4377115-37711598.679100.08
5374346-37434697.95499.35
6380089-38008999.457100.86
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500
标示量(mg)30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%
115.043381603429343423063415143410323411890.55
215.163436793433953435370.06
单位质量响应值RSD%判断
22685.4422660.750.08数据可信
供试品溶液-1236043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%
30min167919-6791917.88017.691.8717.8817.701.87
265758-6575817.31117.31
367465-6746517.76017.76
466841-6684117.59617.60
566126-6612617.40817.41
669179-6917918.21218.21
60min1113314-11331429.83029.321.8829.8629.351.88
2110257-11025729.02629.05
3112321-11232129.56929.60
4108690-10869028.61328.64
5109823-10982328.91128.94
6113873-11387329.97830.01
120min1178196-17819646.91146.311.8946.9946.391.89
2173031-17303145.55145.63
3177632-17763246.76246.84
4171413-17141345.12545.20
5175163-17516346.11346.19
6180115-18011547.41647.50
240min1271529-27152971.48170.950.9071.6471.100.91
2267289-26728970.36570.52
3271454-27145471.46271.62
4266901-26690170.26370.42
5267750-26775070.48670.64
6272078-27207871.62671.79
360min1328050-32805086.36185.711.0286.6485.991.02
2324941-32494185.54285.81
3326949-32694986.07186.35
4323668-32366885.20785.48
5320425-32042584.35384.62
6329522-32952286.74887.03
480min1359829-35982994.72794.100.9795.1594.520.97
2355768-35576893.65894.07
3358345-35834594.33694.76
4357481-35748194.10994.52
5351690-35169092.58493.00
6361578-36157895.18795.61
600min1368935-36893597.12497.921.2097.7098.491.20
2372029-37202997.93898.51
3374979-37497998.71599.29
4372960-37296098.18498.75
5365140-36514096.12596.69
6377721-37772199.437100.02
720min1376612-37661299.14599.601.3299.89100.341.32
2377150-37715099.287100.02
3381635-381635100.467101.21
4379942-379942100.022100.75
5370106-37010697.43298.16
6384525-384525101.228101.98
960min1376938-37693899.23199.731.53100.14100.641.53
2377430-37743099.360100.26
3381174-381174100.346101.25
4382281-382281100.637101.54
5369209-36920997.19698.09
6386052-386052101.630102.55
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1381267-381267100.370100.971.41101.44102.041.41
2383207-383207100.881101.94
3388781-388781102.348103.42
4386067-386067101.634102.70
5374131-37413198.49299.54
6387817-387817102.095103.18
1440min1376203-37620399.03799.641.24100.28100.881.24
2377567-37756799.396100.63
3381034-381034100.309101.56
4382178-382178100.610101.85
5370695-37069597.58798.80
6383261-383261100.895102.15
极限1376613-37661399.14599.311.31100.55100.711.30
2376511-37651199.118100.52
3380630-380630100.203101.62
4380875-380875100.267101.67
5368095-36809596.90398.28
6380603-380603100.196101.62
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