托伐普坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.441995261996931995291996751995641995970.05
216.392012102014032013060.07
单位质量响应值RSD%判断
12140.9412282.250.82数据可信
供试品溶液-3G80SDA2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%
5min119641-196419.6518.884.369.658.884.36
217651-176518.6738.67
318014-180148.8518.85
417741-177418.7178.72
517756-177568.7248.72
617589-175898.6428.64
10min138203-3820318.77118.880.6218.8218.920.61
238117-3811718.72918.78
338603-3860318.96819.02
438721-3872119.02619.07
538517-3851718.92518.97
638338-3833818.83718.89
15min150413-5041324.77125.151.6224.9325.301.61
250375-5037524.75224.90
352638-5263825.86426.02
451105-5110525.11125.26
551310-5131025.21125.36
651301-5130125.20725.36
20min160318-6031829.63729.870.9329.9330.160.93
260531-6053129.74230.03
361461-6146130.19930.50
461539-6153930.23730.53
560495-6049529.72430.02
660359-6035929.65829.95
30min173602-7360236.16535.444.5636.6235.904.49
273332-7333236.03236.49
365585-6558532.22532.69
474606-7460636.65837.12
572337-7233735.54336.00
673272-7327236.00236.46
45min186345-8634542.42642.631.6643.0943.281.63
285752-8575242.13442.79
388316-8831643.39444.04
488786-8878643.62544.29
585918-8591842.21642.87
685395-8539541.95942.62
60min194800-9480046.58046.921.3347.4847.821.31
293478-9347845.93146.82
396716-9671647.52248.41
496814-9681447.57048.48
595871-9587147.10648.00
695321-9532146.83647.73
90min1103326-10332650.77051.891.7251.9353.051.69
2105093-10509351.63852.78
3104052-10405251.12652.28
4108171-10817153.15054.32
5106082-10608252.12453.28
6106918-10691852.53453.69
120min1110338-11033854.21554.910.8755.6556.360.86
2111545-11154554.80856.24
3112055-11205555.05956.49
4113243-11324355.64257.11
5112065-11206555.06356.51
6111296-11129654.68656.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1107229-10722952.68756.503.3854.4358.253.28
2116253-11625357.12158.86
3116327-11632757.15858.90
4116832-11683257.40659.18
5117789-11778957.87659.62
6115518-11551856.76058.51
240min1113810-11381055.92158.312.0757.9560.382.02
2119948-11994858.93760.99
3120265-12026559.09361.15
4118669-11866958.30860.40
5119630-11963058.78160.85
6119761-11976158.84560.91
300min1118849-11884958.39759.060.9460.7461.440.93
2119084-11908458.51260.89
3121907-12190759.89962.29
4120080-12008059.00261.42
5120708-12070859.31061.71
6120520-12052059.21861.61
360min1119462-11946258.69859.722.1461.3662.442.08
2120993-12099359.45062.16
3117704-11770457.83460.55
4123235-12323560.55263.30
5123730-12373060.79563.52
6124145-12414560.99963.72
极限1121194-12119459.54960.091.1362.5463.131.09
2121776-12177659.83562.87
3125040-12504061.43964.48
4121785-12178559.83962.92
5122071-12207159.98063.04
6121853-12185359.87362.93
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