利伐沙班片项目信息
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%
115.284855374857154873914872204858464863420.19
215.114877134872654874890.07
单位质量响应值RSD%判断
31828.6632262.670.96数据可信
供试品溶液-JPS7157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%
5min151119-511199.5339.124.139.539.124.12
249130-491309.1629.16
347496-474968.8588.86
449128-491289.1629.16
545786-457868.5398.54
650808-508089.4759.48
10min1101091-10109118.85318.492.9118.8718.512.91
297618-9761818.20518.22
396309-9630917.96117.98
497814-9781418.24218.26
598083-9808318.29218.31
6104084-10408419.41119.43
15min1127059-12705923.69623.282.4123.7423.322.41
2123251-12325122.98523.03
3122141-12214122.77822.82
4123132-12313222.96323.01
5123477-12347723.02823.07
6129883-12988324.22224.27
20min1146609-14660927.34126.822.2127.4326.902.21
2142364-14236426.55026.63
3140897-14089726.27626.36
4141160-14116026.32526.41
5142980-14298026.66526.75
6148712-14871227.73427.82
30min1175071-17507132.64932.082.0032.7832.222.00
2171291-17129131.94432.07
3169094-16909431.53531.66
4169766-16976631.66031.79
5169598-16959831.62931.76
6177448-17744833.09333.23
45min1202600-20260037.78337.441.5337.9737.621.54
2199568-19956837.21837.40
3198982-19898237.10937.29
4199979-19997937.29537.48
5197436-19743636.82037.00
6205990-20599038.41638.61
60min1224501-22450141.86841.391.5842.1241.631.58
2221943-22194341.39141.63
3220085-22008541.04441.29
4220545-22054541.13041.37
5217262-21726240.51840.76
6227155-22715542.36342.62
极限1262164-26216448.89248.481.0049.2148.791.00
2260750-26075048.62848.94
3257470-25747048.01648.33
4260448-26044848.57248.88
5256188-25618847.77748.09
6262648-26264848.98249.31
利伐沙班片项目信息
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%
115.284874574871464873454869164875854872900.06
215.114908734900434904580.12
单位质量响应值RSD%判断
31890.7132459.171.25数据可信
供试品溶液-JPS7157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%
5min1172680-17268032.07531.951.8932.0831.951.89
2174365-17436532.38832.39
3175799-17579932.65532.65
4170859-17085931.73731.74
5166470-16647030.92230.92
6171761-17176131.90431.90
10min1224668-22466841.73241.421.0341.7941.471.03
2223398-22339841.49641.55
3224367-22436741.67641.73
4224621-22462141.72341.78
5218821-21882140.64640.70
6221899-22189941.21841.27
15min1247983-24798346.06345.680.7446.1945.800.74
2247819-24781946.03246.16
3246462-24646245.78045.90
4245074-24507445.52245.64
5243697-24369745.26745.39
6244356-24435645.38945.51
20min1261882-26188248.64448.610.9048.8448.810.90
2264883-26488349.20249.40
3263795-26379549.00049.20
4261417-26141748.55848.76
5258994-25899448.10848.30
6259353-25935348.17548.37
30min1275939-27593951.25551.510.8551.5451.790.85
2278432-27843251.71952.00
3281452-28145252.27952.56
4277130-27713051.47751.76
5275458-27545851.16651.44
6275401-27540151.15551.43
45min1289234-28923453.72553.770.1954.0954.130.19
2289799-28979953.83054.20
3289531-28953153.78054.15
4289766-28976653.82454.19
5288502-28850253.58953.95
6289908-28990853.85054.21
60min1297014-29701455.17055.050.2255.6355.510.23
2296485-29648555.07255.53
3296880-29688055.14555.60
4296811-29681155.13255.59
5295634-29563454.91455.36
6295525-29552554.89455.35
极限1300257-30025755.77255.780.2656.3256.330.26
2299384-29938455.61056.16
3301476-30147655.99956.55
4300942-30094255.90056.45
5299743-29974355.67756.22
6300074-30007455.73856.28
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