托伐普坦口崩片项目信息
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%
116.483987943982243975933983483975223980960.14
216.554023894024884024380.02
单位质量响应值RSD%判断
24156.3124316.500.47数据可信
供试品溶液-25021701批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149229-4922912.18712.422.0512.1912.422.04
249513-4951312.25812.26
351982-5198212.86912.87
450724-5072412.55712.56
549814-4981412.33212.33
649715-4971512.30812.31
10min190753-9075322.46722.881.3322.4922.901.32
293259-9325923.08823.11
394203-9420323.32123.34
491525-9152522.65822.68
592397-9239722.87422.89
692365-9236522.86622.89
15min1123945-12394530.68430.921.6530.7430.981.66
2127108-12710831.46731.53
3127595-12759531.58831.65
4122516-12251630.33130.39
5123342-12334230.53530.59
6124793-12479330.89430.95
20min1149031-14903136.89537.261.3037.0037.371.30
2152934-15293437.86137.97
3152522-15252237.75937.87
4148025-14802536.64636.75
5149773-14977337.07837.19
6150857-15085737.34737.46
30min1186496-18649646.17046.551.1246.3446.731.12
2191192-19119247.33247.51
3189860-18986047.00347.18
4185951-18595146.03546.21
5186600-18660046.19546.37
6188183-18818346.58746.76
45min1223780-22378055.40056.031.1455.6556.281.13
2229199-22919956.74156.99
3229366-22936656.78357.04
4223740-22374055.39055.64
5225014-22501455.70555.95
6226931-22693156.18056.43
60min1252423-25242362.49162.831.1062.8363.171.10
2256482-25648263.49663.84
3257812-25781263.82564.17
4250964-25096462.13062.47
5251498-25149862.26262.60
6253582-25358262.77863.12
90min1287224-28722471.10671.470.8771.5571.920.87
2291540-29154072.17572.63
3292031-29203172.29672.75
4286701-28670170.97771.42
5286330-28633070.88571.33
6288376-28837671.39271.84
120min1306839-30683975.96276.770.9976.5277.340.99
2314521-31452177.86478.44
3313061-31306177.50378.08
4307506-30750676.12776.69
5309130-30913076.53077.09
6309611-30961176.64977.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1317868-31786878.69379.470.7279.3880.170.72
2321967-32196779.70780.41
3323941-32394180.19680.90
4319050-31905078.98579.67
5320555-32055579.35880.05
6322725-32272579.89580.59
托伐普坦口崩片项目信息
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%
116.483996333998823999064004374005804000880.11
216.554018894019224019060.01
单位质量响应值RSD%判断
24277.1824284.350.03数据可信
供试品溶液-25021702批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145300-4530011.19411.471.7711.1911.471.79
247309-4730911.69011.69
347136-4713611.64811.65
446406-4640611.46711.47
545618-4561811.27311.27
646823-4682311.57011.57
10min184849-8484920.96721.251.0620.9921.271.06
285801-8580121.20221.22
385986-8598621.24821.27
486554-8655421.38821.41
585318-8531821.08321.10
687419-8741921.60221.62
15min1114291-11429128.24228.601.0728.3028.651.06
2114668-11466828.33628.39
3115232-11523228.47528.53
4116655-11665528.82728.88
5115982-11598228.66028.71
6117515-11751529.03929.09
20min1139239-13923934.40734.520.9334.5134.620.93
2138142-13814234.13634.24
3139006-13900634.35034.45
4140976-14097634.83634.94
5139236-13923634.40634.51
6141557-14155734.98035.08
30min1174664-17466443.16143.191.1043.3243.351.10
2171538-17153842.38942.55
3174129-17412943.02943.19
4176135-17613543.52543.69
5175049-17504943.25643.42
6177112-17711243.76643.93
45min1213125-21312552.66552.550.8552.9052.780.85
2210208-21020851.94452.17
3211032-21103252.14852.38
4214277-21427752.95053.18
5212380-21238052.48152.71
6214821-21482153.08453.32
60min1241401-24140159.65259.191.0259.9759.511.02
2236415-23641558.42058.74
3236779-23677958.51058.83
4242242-24224259.86060.18
5239444-23944459.16959.49
6240802-24080259.50459.83
90min1276036-27603668.21167.661.1768.6368.081.17
2268968-26896866.46466.88
3270877-27087766.93667.35
4277236-27723668.50868.93
5274619-27461967.86168.28
6275156-27515667.99468.42
120min1300036-30003674.14273.420.9574.6773.950.95
2293414-29341472.50573.03
3294609-29460972.80173.33
4300418-30041874.23674.77
5297102-29710273.41773.95
6297188-29718873.43873.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1310386-31038676.69976.440.7877.3577.090.78
2306522-30652275.74476.39
3306474-30647475.73376.38
4312016-31201677.10277.76
5309203-30920376.40777.06
6311393-31139376.94877.61
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