利伐沙班口崩片项目信息
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430060-202303对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.103207893203453203873206503209983206340.09
210.093200283195043197660.12
单位质量响应值RSD%判断
31745.9431691.380.13数据可信
供试品溶液-2024122621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%
5min179334-7933422.42122.547.3322.4222.547.32
273937-7393720.89520.90
374164-7416420.95920.96
479494-7949422.46622.47
581708-8170823.09123.09
689817-8981725.38325.38
10min1127203-12720335.94935.924.4535.9935.964.45
2123752-12375234.97435.01
3119673-11967333.82133.86
4126825-12682535.84235.88
5128394-12839436.28536.32
6136677-13667738.62638.67
15min1153497-15349743.38043.532.5143.4843.632.51
2150315-15031542.48142.57
3151192-15119242.72842.82
4153092-15309243.26543.36
5155018-15501843.81043.91
6161125-16112545.53645.64
20min1171984-17198448.60448.841.9548.7749.011.96
2169489-16948947.89948.06
3171059-17105948.34348.51
4171789-17178948.54948.72
5173383-17338349.00049.17
6179173-17917350.63650.82
30min1196942-19694255.65855.971.0955.9156.221.10
2196016-19601655.39655.64
3197398-19739855.78756.03
4197301-19730155.75956.01
5198411-19841156.07356.33
6202121-20212157.12157.39
45min1220680-22068062.36662.930.7362.7163.270.73
2221858-22185862.69963.04
3223301-22330163.10763.44
4221542-22154262.61062.95
5223446-22344663.14863.50
6225125-22512563.62363.98
60min1236703-23670366.89567.310.5367.3467.760.53
2237556-23755667.13667.58
3239139-23913967.58368.02
4237502-23750267.12067.57
5237953-23795367.24867.70
6240098-24009867.85468.32
极限1251927-25192771.19771.490.3671.7672.060.35
2252455-25245571.34671.90
3254579-25457971.94772.50
4252722-25272271.42271.98
5253076-25307671.52272.09
6253055-25305571.51672.10
利伐沙班口崩片项目信息
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430060-202303对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.103188163186893191113184973185113187250.08
210.093186723180153183440.15
单位质量响应值RSD%判断
31556.9331550.450.02数据可信
供试品溶液-2024122621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%
5min1138035-13803539.21438.704.5339.2138.704.53
2138412-13841239.32139.32
3125083-12508335.53435.53
4138073-13807339.22539.22
5134405-13440538.18338.18
6143387-14338740.73440.73
10min1192217-19221754.60653.841.9754.6753.911.97
2189618-18961853.86853.93
3185026-18502652.56452.62
4190660-19066054.16454.23
5185342-18534252.65352.72
6194316-19431655.20355.27
15min1213611-21361160.68460.501.4060.8460.651.41
2214852-21485261.03761.19
3209724-20972459.58059.73
4212874-21287460.47560.63
5209452-20945259.50359.65
6217159-21715961.69261.85
20min1227881-22788164.73864.361.2365.0064.621.23
2228223-22822364.83565.09
3224495-22449563.77664.02
4226154-22615464.24764.50
5222502-22250263.21063.46
6230143-23014365.38165.64
30min1244771-24477169.53669.220.9369.9069.580.93
2245117-24511769.63570.00
3242290-24229068.83169.18
4243647-24364769.21769.58
5239990-23999068.17868.53
6246205-24620569.94470.32
45min1257952-25795273.28173.180.6673.7673.660.66
2258047-25804773.30873.79
3256791-25679172.95173.42
4257459-25745973.14173.62
5255080-25508072.46572.93
6260205-26020573.92174.41
60min1265843-26584375.52375.440.4876.1376.040.49
2266289-26628975.64976.25
3265449-26544975.41176.00
4265572-26557275.44676.05
5263175-26317574.76575.35
6266895-26689575.82176.43
极限1271186-27118677.04077.130.2777.7777.850.27
2272003-27200377.27378.00
3271595-27159577.15777.87
4271822-27182277.22177.95
5270213-27021376.76477.48
6272112-27211277.30478.04
利伐沙班口崩片项目信息
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430060-202303对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.103204223199773193473188143186203194360.24
210.093179083184793181940.13
单位质量响应值RSD%判断
31627.3331535.580.21数据可信
供试品溶液-2024122621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%
5min189382-8938225.37026.056.7325.3726.056.72
287146-8714624.73524.74
397555-9755527.69027.69
483949-8394923.82823.83
599996-9999628.38328.38
692705-9270526.31326.31
10min1139169-13916939.50139.643.4439.5439.683.45
2134741-13474138.24538.29
3144586-14458641.03941.09
4134489-13448938.17338.21
5145933-14593341.42141.47
6138956-13895639.44139.48
15min1164274-16427446.62746.732.3446.7446.842.34
2161858-16185845.94146.05
3169265-16926548.04448.16
4160184-16018445.46645.57
5169303-16930348.05548.17
6162908-16290846.23946.35
20min1180821-18082151.32451.381.8451.5151.561.84
2178990-17899050.80450.99
3185050-18505052.52452.72
4177253-17725350.31150.49
5185010-18501052.51352.71
6178915-17891550.78350.97
30min1202964-20296457.60957.491.5357.8857.761.54
2201734-20173457.26057.53
3206635-20663558.65158.93
4198799-19879956.42756.69
5205395-20539558.29958.58
6199682-19968256.67756.95
45min1222464-22246463.14463.241.0763.5163.601.08
2223009-22300963.29863.66
3225562-22556264.02364.40
4219678-21967862.35362.71
5225289-22528963.94664.33
6220719-22071962.64863.01
60min1235478-23547866.83866.640.7367.3167.110.74
2234425-23442566.53967.01
3236138-23613867.02567.51
4232569-23256966.01266.47
5236913-23691367.24567.73
6233150-23315066.17766.65
极限1245301-24530169.62669.590.7470.2170.170.75
2246189-24618969.87870.46
3246761-24676170.04070.64
4243054-24305468.98869.56
5246828-24682870.05970.66
6242864-24286468.93469.51
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