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%
114.801689671692781688221686071688371689020.15
214.811685241685861685550.03
单位质量响应值RSD%判断
11412.3011381.160.20数据可信
供试品溶液-25052601-2-bc1-js1M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%
30min123568-2356812.34312.703.2812.3412.703.28
223310-2331012.20812.21
324706-2470612.93912.94
423807-2380712.46812.47
525264-2526413.23213.23
624853-2485313.01613.02
60min143791-4379122.93523.191.8422.9623.221.85
243151-4315122.59922.62
345014-4501423.57523.60
443846-4384622.96322.98
545230-4523023.68823.71
644688-4468823.40423.43
120min174236-7423638.88038.901.4538.9438.961.45
272747-7274738.10038.16
374695-7469539.12039.18
473280-7328038.37938.44
575460-7546039.52139.58
675199-7519939.38439.44
240min1112859-11285959.10858.930.6159.2359.060.60
2112314-11231458.82258.94
3112307-11230758.81958.94
4111782-11178258.54458.67
5112177-11217758.75058.88
6113720-11372059.55959.68
360min1139346-13934672.98072.570.6473.2072.790.64
2137791-13779172.16572.38
3138983-13898372.79073.01
4138294-13829472.42972.65
5137374-13737471.94772.17
6139576-13957673.10073.33
480min1154233-15423380.77680.360.6581.1280.710.65
2152904-15290480.08080.42
3153788-15378880.54380.89
4153468-15346880.37680.72
5151767-15176779.48579.83
6154489-15448980.91181.26
600min1162732-16273285.22884.990.5585.7185.470.55
2161920-16192084.80285.28
3163586-16358685.67586.15
4162115-16211584.90585.38
5160934-16093484.28684.76
6162396-16239685.05285.53
720min1168085-16808588.03187.540.4688.6588.150.46
2166935-16693587.42988.04
3167219-16721987.57888.20
4167123-16712387.52788.14
5165839-16583986.85587.47
6167643-16764387.80088.42
960min1173185-17318590.70290.470.5091.4791.230.51
2171997-17199790.08090.84
3172754-17275490.47691.24
4172400-17240090.29191.05
5171888-17188890.02390.79
6174203-17420391.23592.01
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1175117-17511791.71491.500.3292.6392.420.31
2174529-17452991.40692.32
3174915-17491591.60892.53
4175377-17537791.85092.76
5173840-17384091.04591.96
6174518-17451891.40092.32
1440min1175592-17559291.96392.040.3293.0393.110.32
2174982-17498291.64392.71
3176128-17612892.24493.32
4176352-17635292.36193.43
5175216-17521691.76692.83
6176132-17613292.24693.32
极限1175902-17590292.12591.970.4593.3593.190.45
2174712-17471291.50292.72
3175749-17574992.04593.27
4176586-17658692.48393.70
5174590-17459091.43892.66
6176045-17604592.20093.43
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%
114.801685901691531683291685381690941687410.22
214.811685311684481684900.04
单位质量响应值RSD%判断
11401.4211376.770.16数据可信
供试品溶液-25052601-2-bc2-js1M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%
30min134096-3409617.86919.1310.0217.8719.1310.02
240423-4042321.18521.18
333191-3319117.39517.39
433800-3380017.71417.71
541692-4169221.85021.85
635808-3580818.76618.77
60min156434-5643429.57630.467.3529.6130.497.35
261500-6150032.23132.27
355131-5513128.89328.92
453809-5380928.20028.23
565017-6501734.07434.11
656818-5681829.77729.81
120min187789-8778946.00947.504.4046.0947.584.40
293457-9345748.97949.07
387758-8775845.99246.07
489489-8948946.89946.98
597425-9742551.05951.15
687912-8791246.07346.15
240min1129075-12907567.64668.442.6667.8068.602.67
2134582-13458270.53270.70
3127690-12769066.92067.07
4127872-12787267.01567.17
5135406-13540670.96471.14
6128867-12886767.53767.69
360min1153642-15364280.52181.041.9880.7981.321.99
2158754-15875483.20083.49
3152485-15248579.91480.18
4152615-15261579.98380.25
5158304-15830482.96483.26
6152037-15203779.68079.95
480min1165283-16528386.62286.541.2787.0286.951.27
2167422-16742287.74388.17
3164026-16402685.96386.36
4164184-16418486.04686.45
5167562-16756287.81688.25
6162240-16224085.02785.43
600min1170908-17090889.57089.350.9490.1289.910.95
2172371-17237190.33690.91
3170077-17007789.13489.68
4169937-16993789.06189.60
5171786-17178690.03090.61
6167860-16786087.97288.52
720min1173957-17395791.16890.920.6791.8691.630.67
2174414-17441491.40792.13
3173680-17368091.02291.71
4173902-17390291.13991.83
5173781-17378191.07591.81
6171207-17120789.72690.42
960min1177060-17706092.79492.290.8793.6493.150.86
2175816-17581692.14293.02
3176727-17672792.61993.46
4177699-17769993.12993.97
5175992-17599292.23493.12
6173338-17333890.84391.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1177558-17755893.05592.551.1694.0693.561.14
2175655-17565592.05793.09
3177518-17751893.03494.03
4179572-17957294.11095.11
5175503-17550391.97893.01
6173782-17378291.07692.07
1440min1176759-17675992.63692.700.9693.7993.860.95
2176136-17613692.31093.49
3178342-17834293.46694.62
4179409-17940994.02595.18
5175640-17564092.05093.24
6174953-17495391.69092.83
极限1176650-17665092.57992.381.0593.8993.701.03
2175121-17512191.77893.11
3177634-17763493.09594.40
4179047-17904793.83595.15
5174869-17486991.64592.99
6174271-17427191.33292.63
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