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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
119.232010282008102009912009572011442009860.07
219.222046862045022045940.07
单位质量响应值RSD%判断
10451.6910644.851.30数据可信
供试品溶液-2025050921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%
5min120507-2050711.65411.486.6511.6511.486.65
220032-2003211.38411.38
321680-2168012.32112.32
420829-2082911.83711.84
520440-2044011.61611.62
617701-1770110.05910.06
10min140178-4017822.83321.993.4222.8522.013.41
239090-3909022.21522.23
339432-3943222.40922.43
438637-3863721.95721.98
538553-3855321.90921.93
636286-3628620.62120.64
15min154654-5465431.05930.841.9031.1230.891.91
254878-5487831.18731.24
355338-5533831.44831.51
454161-5416130.77930.84
554158-5415830.77830.83
652367-5236729.76029.81
20min168235-6823538.77738.411.5538.8938.521.56
268320-6832038.82638.93
368589-6858938.97939.09
467327-6732738.26138.37
567278-6727838.23438.34
665759-6575937.37037.47
30min188882-8888250.51149.821.1950.6849.991.18
288571-8857150.33450.51
386595-8659549.21149.39
487563-8756349.76149.93
588025-8802550.02450.19
686336-8633649.06449.23
45min1113308-11330864.39263.181.4364.6563.441.43
2111988-11198863.64263.90
3111923-11192363.60563.86
4110635-11063562.87363.13
5110521-11052162.80863.06
6108729-10872961.79062.03
60min1128347-12834772.93972.690.7273.3073.050.72
2128972-12897273.29473.66
3128462-12846273.00473.37
4128063-12806372.77773.14
5126711-12671172.00972.37
6126878-12687872.10472.45
90min1155415-15541588.32185.881.5988.8186.361.59
2151881-15188186.31386.80
3151210-15121085.93286.42
4149950-14995085.21585.70
5149557-14955784.99285.47
6148695-14869584.50284.97
120min1161903-16190392.00893.571.1992.6494.201.18
2163739-16373993.05293.68
3165407-16540794.00094.63
4164085-16408593.24893.87
5165019-16501993.77994.40
6167776-16777695.34695.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1179179-179179101.826103.341.17102.61104.121.16
2181514-181514103.153103.94
3182904-182904103.943104.73
4180572-180572102.618103.40
5181526-181526103.160103.94
6185376-185376105.348106.12
240min1186579-186579106.031107.521.87106.99108.471.85
2189669-189669107.787108.74
3191504-191504108.830109.79
4183896-183896104.507105.46
5189666-189666107.786108.73
6193843-193843110.160111.10
极限1188270-188270106.992109.191.62108.13110.321.61
2191621-191621108.897110.03
3196110-196110111.448112.59
4189784-189784107.853108.98
5191530-191530108.845109.97
6195518-195518111.111112.24
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
119.232018882020182020592019492021482020120.05
219.222055422055412055420.01
单位质量响应值RSD%判断
10505.0410694.171.27数据可信
供试品溶液-2025051021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%
5min119049-1904910.77311.839.0910.7711.839.08
218932-1893210.70710.71
320972-2097211.86011.86
420228-2022811.44011.44
523257-2325713.15313.15
623083-2308313.05413.05
10min138966-3896622.03722.333.4222.0522.343.44
238807-3880721.94721.96
339284-3928422.21722.24
438044-3804421.51521.53
539796-3979622.50622.53
641967-4196723.73423.76
15min155665-5566531.48131.462.3131.5431.512.31
254992-5499231.10031.15
354552-5455230.85130.91
454666-5466630.91630.97
555843-5584331.58131.64
658006-5800632.80532.87
20min167250-6725038.03238.771.6238.1438.881.63
268888-6888838.95939.07
368200-6820038.57038.68
467676-6767638.27338.38
568982-6898239.01239.12
670364-7036439.79339.91
30min189046-8904650.35950.531.2250.5350.701.22
289296-8929650.50050.67
388752-8875250.19350.37
487940-8794049.73349.90
589999-8999950.89851.07
691082-9108251.51051.69
45min1112443-11244363.59163.342.3663.8563.602.36
2114098-11409864.52764.78
3111383-11138362.99163.25
4107153-10715360.59960.85
5112418-11241863.57763.84
6114470-11447064.73765.01
60min1130791-13079173.96773.152.0274.3373.512.02
2131253-13125374.22974.59
3126292-12629271.42371.78
4125792-12579271.14071.49
5131661-13166174.45974.83
6130291-13029173.68474.06
90min1151949-15194985.93385.580.5886.4286.060.58
2151755-15175585.82386.31
3150343-15034385.02585.50
4150237-15023784.96585.44
5152342-15234286.15586.65
6151274-15127485.55186.05
120min1164679-16467993.13294.071.2493.7694.691.22
2166378-16637894.09394.72
3168989-16898995.57096.19
4168274-16827495.16595.78
5166060-16606093.91394.55
6163598-16359892.52193.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1198851-198851112.458105.933.16113.24106.723.13
2184858-184858104.544105.33
3187433-187433106.000106.78
4186012-186012105.197105.97
5182378-182378103.142103.93
6184334-184334104.248105.04
240min1190255-190255107.596107.791.46108.57108.761.44
2187906-187906106.268107.23
3193475-193475109.417110.38
4194367-194367109.922110.87
5189832-189832107.357108.32
6187774-187774106.193107.16
极限1191427-191427108.259108.941.05109.41110.091.03
2190745-190745107.873109.01
3196254-196254110.989112.13
4193564-193564109.468110.60
5192115-192115108.648109.79
6191733-191733108.432109.58
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
119.232013702012172010312012332008842011470.10
219.222003472004192003830.03
单位质量响应值RSD%判断
10460.0610425.750.24数据可信
供试品溶液-2025051121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%
5min118956-1895610.88011.168.9310.8811.168.95
217062-170629.7939.79
319392-1939211.13111.13
418943-1894310.87310.87
522379-2237912.84512.85
619972-1997211.46411.46
10min136546-3654620.97721.603.6420.9921.623.64
235735-3573520.51120.53
338132-3813221.88721.91
437316-3731621.41921.44
538689-3868922.20722.23
639399-3939922.61422.63
15min152611-5261130.19830.382.1530.2530.432.16
250858-5085829.19129.24
353330-5333030.61030.67
453288-5328830.58630.64
553214-5321430.54430.60
654232-5423231.12831.18
20min165943-6594337.85037.982.0937.9538.082.09
263575-6357536.49136.59
367058-6705838.49038.60
467099-6709938.51338.62
566107-6610737.94438.05
667194-6719438.56838.68
30min186456-8645649.62449.661.3349.7949.831.34
284412-8441248.45148.61
386433-8643349.61149.78
487658-8765850.31450.48
586756-8675649.79649.97
687417-8741750.17650.35
45min1110031-11003163.15662.322.2463.4062.572.24
2103663-10366359.50059.74
3109133-10913362.64062.89
4109743-10974362.99063.24
5109509-10950962.85663.11
6109379-10937962.78163.04
60min1126976-12697672.88272.440.6273.2472.800.63
2125246-12524671.88972.23
3126451-12645172.58072.94
4127167-12716772.99173.35
5125515-12551572.04372.40
6125914-12591472.27272.63
90min1149954-14995486.07185.311.9586.5585.781.95
2143916-14391682.60583.06
3148068-14806884.98885.47
4152812-15281287.71188.19
5148455-14845585.21085.69
6148534-14853485.25585.74
120min1161635-16163592.77593.461.3293.3994.081.32
2161532-16153292.71693.31
3160441-16044192.09092.71
4166431-16643195.52896.15
5163888-16388894.06894.69
6163060-16306093.59394.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1182654-182654104.840104.241.67105.61105.011.66
2177795-177795102.051102.80
3181896-181896104.405105.18
4186323-186323106.946107.73
5182088-182088104.515105.29
6178889-178889102.679103.46
240min1190831-190831109.533108.731.26110.48109.671.26
2187428-187428107.580108.50
3189693-189693108.880109.83
4193331-193331110.968111.93
5187057-187057107.367108.32
6188218-188218108.033108.98
极限1192984-192984110.769109.421.67111.90110.551.66
2189720-189720108.895110.00
3190217-190217109.181110.31
4195664-195664112.307113.46
5187719-187719107.747108.88
6187496-187496107.619108.75
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