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430060-202202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)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%
115.144850624849894860364847684856894853090.11
215.224869664865344867500.07
单位质量响应值RSD%判断
32054.7631980.950.17数据可信
供试品溶液-24083001-1批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1280135-28013552.28655.849.4652.2955.849.46
2277234-27723451.74551.74
3286102-28610253.40053.40
4301380-30138056.25156.25
5296402-29640255.32255.32
6353664-35366466.01066.01
10min1387954-38795472.41073.853.5172.5073.943.52
2382673-38267371.42471.51
3391568-39156873.08573.17
4406592-40659275.88975.98
5386755-38675572.18672.28
6418420-41842078.09678.21
15min1425895-42589579.49280.382.2979.7080.602.30
2422003-42200378.76578.97
3430706-43070680.39080.60
4440179-44017982.15882.38
5420513-42051378.48778.70
6444606-44460682.98483.22
20min1444760-44476083.01383.702.0883.3584.052.09
2440623-44062382.24182.58
3450207-45020784.02984.37
4458842-45884285.64186.00
5436972-43697281.55981.90
6459203-45920385.70886.09
30min1465539-46553986.89187.151.6787.3787.641.67
2460861-46086186.01886.49
3469807-46980787.68888.17
4475865-47586588.81889.32
5455666-45566685.04885.53
6473814-47381488.43688.96
45min1479071-47907189.41789.711.5190.0490.341.52
2474505-47450588.56589.18
3482992-48299290.14990.78
4491559-49155991.74892.40
5471454-47145487.99588.62
6484257-48425790.38591.05
60min1486383-48638390.78291.051.5691.5591.841.56
2483056-48305690.16190.93
3490384-49038491.52892.31
4500777-50077793.46894.27
5478383-47838389.28890.06
6488087-48808791.10091.92
极限1500227-50022793.36593.261.0894.2994.191.09
2495604-49560492.50393.42
3503090-50309093.90094.83
4505967-50596794.43795.39
5491173-49117391.67692.59
6501842-50184293.66794.64
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430060-202202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)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%
115.144874424868634871504863154867904869120.09
215.224960604952314956460.12
单位质量响应值RSD%判断
32160.6332565.440.89数据可信
供试品溶液-24083001-3批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299246-29924655.25953.644.8255.2653.644.82
2293313-29331354.16454.16
3306267-30626756.55656.56
4269696-26969649.80349.80
5277433-27743351.23151.23
6296962-29696254.83854.84
10min1401307-40130774.10673.393.0274.2073.483.02
2387004-38700471.46571.56
3416372-41637276.88876.98
4383582-38358270.83370.92
5393516-39351672.66872.75
6402923-40292374.40574.50
15min1436678-43667880.63880.302.4380.8580.512.43
2421025-42102577.74777.96
3451510-45151083.37783.60
4430503-43050379.49879.70
5428944-42894479.21079.42
6440315-44031581.31081.52
20min1452292-45229283.52183.842.4283.8784.182.42
2437690-43769080.82581.16
3470659-47065986.91387.27
4453226-45322683.69484.03
5449889-44988983.07883.42
6460277-46027784.99685.35
30min1471344-47134487.03987.282.4387.5387.762.43
2456110-45611084.22684.70
3490856-49085690.64391.15
4471490-47149087.06687.54
5468123-46812386.44586.92
6477859-47785988.24388.74
45min1484929-48492989.54889.912.2790.1890.542.27
2470097-47009786.80987.42
3504187-50418793.10493.76
4487954-48795490.10790.72
5483687-48368789.31989.94
6490450-49045090.56891.21
60min1491432-49143290.74991.052.4391.5391.822.42
2472433-47243387.24188.00
3508435-50843593.88994.70
4495843-49584391.56492.33
5491006-49100690.67091.44
6499064-49906492.15892.95
极限1505854-50585493.41293.351.7894.3594.281.78
2492278-49227890.90591.81
3519651-51965195.96096.93
4504624-50462493.18594.11
5501788-50178892.66193.58
6508976-50897693.98994.93
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430060-202202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)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%
115.144866114861514862914867274871334865830.08
215.224869474865284867380.07
单位质量响应值RSD%判断
32138.9031980.160.36数据可信
供试品溶液-24083001-2批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1368040-36804068.60466.115.9868.6066.115.98
2353184-35318465.83565.84
3354804-35480466.13766.14
4347830-34783064.83764.84
5320377-32037759.72059.72
6383712-38371271.52671.53
10min1416858-41685877.70476.742.5877.8276.852.58
2423615-42361578.96479.07
3408785-40878576.19976.31
4406666-40666675.80475.91
5394510-39451073.53873.64
6419581-41958178.21278.33
15min1420500-42050078.38380.051.6278.6380.291.62
2429761-42976180.10980.35
3433378-43337880.78481.02
4431438-43143880.42280.66
5422522-42252278.76078.98
6439122-43912281.85482.10
20min1435263-43526381.13582.291.1781.5182.661.17
2438566-43856681.75182.13
3447223-44722383.36483.74
4442855-44285582.55082.92
5437580-43758081.56781.92
6447340-44734083.38683.77
30min1461539-46153986.03385.510.7286.5486.020.72
2461884-46188486.09786.61
3460257-46025785.79486.30
4457411-45741185.26385.77
5453090-45309084.45884.95
6458149-45814985.40185.93
45min1483341-48334190.09788.382.2790.7589.032.26
2490698-49069891.46892.12
3473442-47344288.25288.91
4466381-46638186.93587.58
5463843-46384386.46287.09
6467018-46701887.05487.72
60min1488082-48808290.98190.013.3091.7890.813.28
2512442-51244295.52196.33
3480046-48004689.48390.28
4475348-47534888.60789.40
5469089-46908987.44088.21
6472398-47239888.05788.87
极限1501414-50141493.46691.262.1694.4292.212.15
2504756-50475694.08995.05
3482948-48294890.02490.97
4481614-48161489.77590.72
5484932-48493290.39391.31
6481925-48192589.83390.79
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