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%
115.063498783497173489423498923498543496570.12
215.103504303503253503780.03
单位质量响应值RSD%判断
23217.6023203.840.05数据可信
供试品溶液-1236043批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min148350-4835012.43412.571.9312.4312.571.93
248838-4883812.55912.56
349635-4963512.76412.76
449313-4931312.68112.68
549827-4982712.81312.81
647304-4730412.16512.16
60min182207-8220721.14021.472.0021.1621.492.01
283723-8372321.53021.55
382630-8263021.24921.27
485262-8526221.92621.95
585623-8562322.01922.04
681552-8155220.97220.99
120min1132421-13242134.05334.461.2934.1134.521.29
2134604-13460434.61434.67
3132034-13203433.95334.01
4136492-13649235.10035.16
5135179-13517934.76234.82
6133357-13335734.29434.35
240min1205331-20533152.80253.411.0752.9253.521.06
2208728-20872853.67653.79
3206545-20654553.11553.23
4211572-21157254.40754.52
5206637-20663753.13853.25
6207253-20725353.29753.41
360min1256627-25662765.99366.600.7866.1966.800.78
2261276-26127667.18967.39
3260633-26063367.02467.23
4260398-26039866.96367.17
5257444-25744466.20466.41
6257517-25751766.22266.42
480min1286062-28606273.56374.601.1873.8774.911.17
2293310-29331075.42775.74
3293795-29379575.55175.86
4292170-29217075.13475.45
5288368-28836874.15674.47
6286894-28689473.77774.09
600min1316730-31673081.44982.391.7281.8882.831.71
2325344-32534483.66584.11
3328213-32821384.40284.84
4320784-32078482.49282.94
5317521-31752181.65382.09
6313841-31384180.70681.14
720min1330534-33053484.99985.911.6685.5786.491.65
2339114-33911487.20687.79
3342245-34224588.01188.59
4334101-33410185.91686.50
5330224-33022484.91985.49
6328310-32831084.42785.00
960min1349640-34964089.91290.751.7490.6291.471.73
2357536-35753691.94392.67
3362153-36215393.13093.86
4353475-35347590.89991.62
5348987-34898789.74490.46
6345596-34559688.87289.58
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1361571-36157192.98193.621.8493.8494.501.83
2369076-36907694.91195.79
3374173-37417396.22197.10
4364854-36485493.82594.70
5357834-35783492.02092.89
6356946-35694691.79192.65
1440min1366242-36624294.18294.792.0395.2095.822.02
2375877-37587796.65997.70
3378886-37888697.43398.48
4368514-36851494.76695.80
5361871-36187193.05894.08
6360243-36024392.63993.65
极限1366581-36658194.26994.611.9395.4495.791.92
2373991-37399196.17497.37
3378035-37803597.21498.42
4367363-36736394.47095.66
5362112-36211293.12094.29
6359262-35926292.38793.55
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%
115.063495283492963492273491303487973491960.08
215.103467713465543466620.05
单位质量响应值RSD%判断
23186.9922957.750.71数据可信
供试品溶液-1236043批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min146358-4635811.99312.524.3511.9912.524.37
248644-4864412.58412.58
350821-5082113.14813.15
445932-4593211.88311.88
547870-4787012.38412.38
650776-5077613.13613.14
60min179060-7906020.45321.132.4520.4721.152.45
282904-8290421.44821.47
383681-8368121.64921.67
479512-7951220.57020.59
583347-8334721.56221.58
681512-8151221.08821.11
120min1128626-12862633.27633.911.9933.3333.971.99
2131676-13167634.06534.12
3134223-13422334.72434.78
4128536-12853633.25333.31
5134019-13401934.67134.73
6129488-12948833.49933.56
240min1204591-20459152.92952.401.8853.0452.511.88
2202999-20299952.51752.63
3205358-20535853.12753.24
4196615-19661550.86550.97
5206328-20632853.37853.49
6199302-19930251.56151.67
360min1255431-25543166.08165.371.4866.2865.571.49
2252613-25261365.35265.55
3255970-25597066.22166.43
4248076-24807664.17964.37
5255833-25583366.18566.39
6248162-24816264.20164.40
480min1286079-28607974.01073.221.2374.3273.531.23
2282552-28255273.09873.41
3286594-28659474.14374.46
4280201-28020172.49072.79
5284912-28491273.70874.02
6277914-27791471.89872.20
600min1316376-31637681.84880.911.3582.2881.341.35
2312468-31246880.83781.27
3317130-31713082.04382.48
4310487-31048780.32580.75
5314221-31422181.29181.73
6305784-30578479.10879.53
720min1330088-33008885.39684.681.1285.9685.241.11
2326641-32664184.50485.07
3331214-33121485.68786.26
4326333-32633384.42484.98
5328631-32863185.01985.59
6320974-32097483.03883.60
960min1349574-34957490.43789.471.1291.1590.171.12
2343739-34373988.92789.63
3349209-34920990.34291.06
4347121-34712189.80290.50
5346033-34603389.52190.23
6339296-33929687.77888.47
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1358486-35848692.74292.260.9693.6093.120.96
2357162-35716292.40093.26
3358966-35896692.86693.73
4358714-35871492.80193.65
5356445-35644592.21493.08
6349931-34993190.52991.37
1440min1364915-36491594.40693.650.9495.4294.650.94
2360856-36085693.35594.36
3364035-36403594.17895.20
4364706-36470694.35195.35
5361330-36133093.47894.49
6356034-35603492.10893.10
极限1365176-36517694.47393.671.0295.6594.841.02
2361384-36138493.49294.66
3364212-36421294.22495.40
4364408-36440894.27495.43
5362116-36211693.68194.85
6355158-35515891.88193.03
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