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%
116.553993613991223988483990813990033990830.05
216.454001924001424001670.01
单位质量响应值RSD%判断
24113.7824326.260.63数据可信
供试品溶液-2025030721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%
5min132685-326858.0978.5511.158.108.5511.12
233580-335808.3198.32
330826-308267.6377.64
433028-330288.1828.18
535107-351078.6978.70
641835-4183510.36410.36
10min168147-6814716.88217.506.5516.9017.526.55
267243-6724316.65816.67
366522-6652216.48016.49
474651-7465118.49418.51
569291-6929117.16617.18
677999-7799919.32319.34
15min193065-9306523.05523.844.6523.1023.894.66
292555-9255522.92922.97
393984-9398423.28323.32
494191-9419123.33423.38
5100337-10033724.85724.90
6103324-10332425.59725.65
20min1113443-11344328.10429.053.9528.1829.143.96
2113162-11316228.03428.11
3116107-11610728.76428.84
4122651-12265130.38530.47
5114765-11476528.43128.52
6123514-12351430.59930.69
30min1143325-14332535.50636.232.4635.6336.362.47
2143288-14328835.49735.62
3148239-14823936.72436.85
4145612-14561236.07336.21
5144437-14443735.78235.91
6152535-15253537.78837.93
45min1176498-17649843.72544.612.3943.9144.802.39
2177457-17745743.96244.15
3185156-18515645.86946.06
4178628-17862844.25244.45
5176773-17677343.79343.98
6185883-18588346.04946.26
60min1202085-20208550.06350.851.7750.3251.121.77
2202843-20284350.25150.51
3207341-20734151.36551.63
4204785-20478550.73251.00
5202938-20293850.27550.54
6211561-21156152.41152.69
90min1234989-23498958.21559.301.2458.5659.661.24
2240920-24092059.68460.03
3241892-24189259.92560.28
4238822-23882259.16459.52
5237075-23707558.73159.08
6242543-24254360.08660.46
120min1260737-26073764.59365.221.5365.0365.661.54
2258909-25890964.14064.58
3266532-26653266.02966.48
4261971-26197164.89965.35
5261699-26169964.83265.28
6269640-26964066.79967.27
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1289198-28919871.64472.341.0972.1972.901.10
2290336-29033671.92672.48
3291942-29194272.32472.88
4291030-29103072.09872.66
5291493-29149372.21372.77
6298161-29816173.86574.45
240min1306202-30620275.85776.721.0776.5277.401.07
2307466-30746676.17076.84
3315460-31546078.15078.83
4308838-30883876.51077.19
5308819-30881976.50577.18
6311289-31128977.11777.82
极限1310358-31035876.88677.870.9277.6878.680.93
2311829-31182977.25178.05
3317054-31705478.54579.36
4314606-31460677.93978.75
5314267-31426777.85578.66
6317826-31782678.73679.57
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%
116.554009764009424014894016304012054012480.08
216.454051744048904050320.05
单位质量响应值RSD%判断
24244.5924622.011.10数据可信
供试品溶液-2025030721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%
5min127235-272356.6886.763.466.696.773.48
229381-293817.2157.22
327694-276946.8016.80
427265-272656.6966.70
526904-269046.6076.61
626800-268006.5826.58
10min158206-5820614.29414.261.8414.3114.271.83
259076-5907614.50814.52
357594-5759414.14414.16
458441-5844114.35214.36
558902-5890214.46514.48
656171-5617113.79513.81
15min182256-8225620.20120.022.8720.2420.062.87
281896-8189620.11220.15
385569-8556921.01421.05
480718-8071819.82319.86
579646-7964619.56019.59
679047-7904719.41219.45
20min1101208-10120824.85524.341.6024.9224.411.60
2100924-10092424.78524.85
398341-9834124.15124.22
498887-9888724.28524.35
597837-9783724.02724.09
697512-9751223.94724.01
30min1129613-12961331.83131.431.3831.9431.541.39
2129984-12998431.92232.03
3125964-12596430.93431.04
4127311-12731131.26531.37
5128971-12897131.67331.78
6126138-12613830.97731.08
45min1160510-16051039.41839.131.1039.5839.291.10
2162089-16208939.80639.97
3157224-15722438.61138.77
4158980-15898039.04239.20
5158012-15801238.80538.97
6159104-15910439.07339.23
60min1184457-18445745.29945.481.1345.5345.711.13
2187532-18753246.05446.28
3187877-18787746.13946.37
4184486-18448645.30645.53
5184400-18440045.28545.51
6182465-18246544.81045.03
90min1216413-21641353.14752.970.8053.4553.270.80
2218720-21872053.71454.02
3214450-21445052.66552.97
4215662-21566252.96353.26
5214142-21414252.58952.89
6214742-21474252.73753.03
120min1238933-23893358.67758.600.8059.0758.990.80
2242001-24200159.43159.83
3237459-23745958.31558.71
4239118-23911858.72359.11
5236710-23671058.13258.52
6237448-23744858.31358.70
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1269774-26977466.25165.910.8466.7466.390.84
2272038-27203866.80767.30
3266207-26620765.37565.86
4268220-26822065.87066.36
5266233-26623365.38265.87
6267721-26772165.74766.23
240min1285333-28533370.07270.370.7570.6770.970.75
2290474-29047471.33571.94
3285653-28565370.15170.75
4287548-28754870.61671.21
5284669-28466969.90970.50
6285651-28565170.15170.74
极限1291782-29178271.65671.720.5972.3772.440.59
2294691-29469172.37173.10
3289531-28953171.10371.82
4292952-29295271.94372.66
5291958-29195871.69972.41
6291383-29138371.55872.27
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