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%
114.954711064709644712704702124698424706790.14
215.054694964696814695880.03
单位质量响应值RSD%判断
31483.5531201.860.64数据可信
供试品溶液-24100601-1批-pH1.2(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%
5min1301535-30153557.49453.564.5257.4953.564.52
2281497-28149753.67353.67
3276785-27678552.77552.77
4288572-28857255.02255.02
5268815-26881551.25551.26
6268346-26834651.16651.17
10min1388749-38874974.12372.211.9374.2272.301.93
2377270-37727071.93472.02
3376196-37619671.72971.82
4380720-38072072.59272.68
5382511-38251172.93373.02
6366951-36695169.96770.05
15min1419372-41937279.96278.791.0480.1879.001.04
2410243-41024378.22178.43
3409426-40942678.06578.27
4413776-41377678.89579.11
5417164-41716479.54179.75
6409410-40941078.06278.26
20min1437232-43723283.36782.250.9583.7282.590.96
2428893-42889381.77782.12
3427467-42746781.50581.84
4431191-43119182.21582.56
5435414-43541483.02083.36
6427972-42797281.60281.93
30min1457653-45765387.26186.031.0187.7586.511.01
2450118-45011885.82486.30
3444583-44458384.76985.24
4451170-45117086.02586.51
5454684-45468486.69587.17
6449083-44908385.62786.09
45min1471562-47156289.91389.180.6190.5589.800.62
2470017-47001789.61890.24
3464085-46408588.48789.10
4467853-46785389.20689.83
5467759-46775989.18889.81
6465006-46500688.66389.27
60min1477379-47737991.02290.240.6891.8191.010.69
2472103-47210390.01690.78
3470148-47014889.64390.41
4476395-47639590.83491.61
5473931-47393190.36591.14
6469671-46967189.55290.31
极限1481866-48186691.87891.330.5692.8292.250.56
2477926-47792691.12692.04
3475259-47525990.61891.53
4482270-48227091.95592.88
5478307-47830791.19992.12
6478396-47839691.21692.12
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%
114.954697054696024698254699264695064697130.04
215.054695174692784693980.04
单位质量响应值RSD%判断
31418.9331189.240.52数据可信
供试品溶液-JPS7664批-pH1.2(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%
5min1315183-31518360.17059.141.9860.1759.141.98
2310398-31039859.25659.26
3313717-31371759.89059.89
4302945-30294557.83357.83
5314951-31495160.12560.13
6301542-30154257.56657.57
10min1392324-39232474.89674.402.1175.0074.502.11
2391247-39124774.69174.79
3398254-39825476.02876.13
4387631-38763174.00074.10
5394255-39425575.26575.37
6374530-37453071.49971.60
15min1422245-42224580.60879.942.1580.8380.162.15
2421873-42187380.53780.76
3427914-42791481.69181.92
4417660-41766079.73379.95
5421093-42109380.38880.61
6401747-40174776.69576.91
20min1436821-43682183.39183.011.9583.7583.361.95
2439271-43927183.85984.22
3444093-44409384.77985.14
4432544-43254482.57482.93
5436803-43680383.38883.75
6419350-41935080.05680.40
30min1453303-45330386.53786.192.0687.0486.682.06
2454388-45438886.74587.24
3461539-46153988.11088.61
4450695-45069586.04086.53
5454902-45490286.84387.34
6434016-43401682.85583.33
45min1465841-46584188.93188.662.0689.5789.302.06
2468055-46805589.35490.00
3474872-47487290.65591.31
4463526-46352688.48989.12
5467709-46770989.28889.93
6446571-44657185.25285.87
60min1470690-47069089.85789.552.2290.6590.342.22
2475478-47547890.77191.56
3478730-47873091.39292.19
4467185-46718589.18889.97
5473048-47304890.30791.10
6449439-44943985.80086.56
极限1470742-47074289.86789.582.0590.8190.512.05
2473983-47398390.48591.43
3477667-47766791.18992.14
4464905-46490588.75289.68
5476144-47614490.89891.84
6451921-45192186.27487.17
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%
114.954701894701444703304699874700524701400.03
215.054697624701594699600.06
单位质量响应值RSD%判断
31447.4931226.580.50数据可信
供试品溶液-24100601-1批-pH6.8(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%
5min1313393-31339359.76564.414.1459.7764.414.14
2342583-34258365.33265.33
3339258-33925864.69864.70
4339278-33927864.70164.70
5356489-35648967.98467.98
6335499-33549963.98163.98
10min1428580-42858081.73283.331.2981.8383.441.30
2436612-43661283.26383.37
3437469-43746983.42783.53
4436118-43611883.16983.28
5446264-44626485.10485.22
6436825-43682583.30483.41
15min1456579-45657987.07188.691.2187.3188.931.21
2465511-46551188.77489.02
3467143-46714389.08689.33
4462595-46259588.21888.46
5473628-47362890.32290.58
6464852-46485288.64988.89
20min1469227-46922789.48390.901.1389.8691.301.14
2473845-47384590.36490.76
3479003-47900391.34791.74
4474036-47403690.40090.79
5484437-48443792.38492.79
6479544-47954491.45191.84
30min1479651-47965191.47193.481.4192.0094.021.42
2490053-49005393.45594.00
3491583-49158393.74694.29
4486241-48624192.72893.27
5500188-50018895.38795.95
6493362-49336294.08694.63
45min1489413-48941393.33395.071.1894.0295.771.18
2498212-49821295.01195.71
3500926-50092695.52896.23
4495201-49520194.43695.14
5506651-50665196.62097.34
6500610-50061095.46896.17
60min1493711-49371194.15295.761.1794.9996.621.18
2500868-50086895.51796.38
3504765-50476596.26097.12
4498564-49856495.07895.93
5510890-51089097.42898.31
6503916-50391696.09896.96
极限1509586-50958697.18098.040.9698.1799.060.96
2512248-51224897.68798.71
3516244-51624498.44999.47
4509648-50964897.19298.21
5522594-52259499.660100.70
6514203-51420398.06099.08
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%
114.954697024696674697404691924695534695710.05
215.054701754701304701520.01
单位质量响应值RSD%判断
31409.4331239.340.39数据可信
供试品溶液-JPS7664批-pH6.8(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%
5min1342432-34243265.32965.962.6765.3365.962.67
2345739-34573965.96065.96
3355812-35581267.88267.88
4336366-33636664.17264.17
5336551-33655164.20764.21
6357559-35755968.21568.21
10min1418137-41813779.77280.311.8679.8880.421.86
2416575-41657579.47479.58
3427488-42748881.55681.67
4421180-42118080.35280.46
5410412-41041278.29878.41
6432089-43208982.43482.55
15min1446950-44695085.26985.711.8485.5185.951.84
2444466-44446684.79585.04
3455804-45580486.95887.21
4449558-44955885.76686.01
5437774-43777483.51883.76
6460904-46090487.93188.18
20min1460428-46042887.84088.561.8788.2288.941.88
2459503-45950387.66488.05
3469288-46928889.53089.92
4465724-46572488.85189.23
5452638-45263886.35486.73
6477559-47755991.10891.51
30min1477597-47759791.11692.051.8491.6592.591.84
2477221-47722191.04491.57
3487750-48775093.05393.60
4483753-48375392.29092.82
5472024-47202490.05290.57
6496677-49667794.75695.31
45min1491419-49141993.75394.781.9394.4395.471.93
2490693-49069393.61494.30
3503287-50328796.01796.72
4497537-49753794.92095.61
5485888-48588892.69793.37
6511987-51198797.67798.38
60min1498517-49851795.10796.112.1495.9596.962.13
2497065-49706594.83095.67
3510454-51045497.38498.24
4504192-50419296.18997.03
5491298-49129893.72994.55
6521179-52117999.430100.30
极限1500787-50078795.54096.522.0396.5497.522.03
2500128-50012895.41496.41
3513482-51348297.96298.98
4505421-50542196.42497.43
5493670-49367094.18295.16
6522045-52204599.595100.63
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