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%
116.554014634015564018354016624018674016770.05
216.454032334028354030340.07
单位质量响应值RSD%判断
24270.5124500.550.67数据可信
供试品溶液-2K72SDB2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%
5min123546-235465.7945.648.115.795.648.15
224365-243655.9956.00
324430-244306.0116.01
423119-231195.6885.69
519402-194024.7744.77
622650-226505.5735.57
10min172959-7295917.95217.464.0517.9617.474.06
273623-7362318.11518.13
371839-7183917.67617.69
471585-7158517.61417.62
565646-6564616.15216.16
670106-7010617.25017.26
15min1105572-10557225.97625.632.0626.0225.672.07
2105932-10593226.06526.11
3106003-10600326.08226.12
4103612-10361225.49425.53
5100489-10048924.72624.76
6103393-10339325.44025.48
20min1130568-13056832.12731.781.3832.2131.861.39
2130883-13088332.20432.29
3130698-13069832.15932.24
4128621-12862131.64831.73
5127096-12709631.27231.35
6127171-12717131.29131.37
30min1168725-16872541.51541.501.2641.6541.631.26
2170145-17014541.86542.00
3171920-17192042.30142.44
4166904-16690441.06741.20
5166239-16623940.90441.03
6167931-16793141.32041.45
45min1209807-20980751.62451.640.7151.8351.840.71
2212242-21224252.22352.43
3211030-21103051.92552.13
4208751-20875151.36451.57
5208945-20894551.41251.61
6208501-20850151.30251.50
60min1242013-24201359.54859.810.7159.8460.100.72
2244964-24496460.27460.57
3245403-24540360.38260.68
4242281-24228159.61459.90
5242762-24276259.73260.01
6241098-24109859.32359.61
90min1282854-28285469.59769.870.8369.9970.260.83
2285021-28502170.13070.52
3287830-28783070.82171.22
4280869-28086969.10969.50
5283980-28398069.87470.26
6283159-28315969.67270.06
120min1313389-31338977.11077.550.9277.6278.050.91
2316445-31644577.86278.37
3319202-31920278.54179.05
4311024-31102476.52877.03
5316674-31667477.91978.42
6314281-31428177.33077.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1342052-34205284.16385.120.8684.8085.760.86
2345445-34544584.99885.64
3350502-35050286.24286.89
4343823-34382384.59985.23
5347645-34764585.53986.17
6346190-34619085.18185.81
240min1360913-36091388.80489.360.5589.5890.140.55
2365176-36517689.85390.64
3364726-36472689.74290.53
4361088-36108888.84789.62
5364837-36483789.76990.54
6362214-36221489.12489.90
极限1361626-36162688.97990.380.9589.9091.310.95
2369894-36989491.01491.95
3371394-37139491.38392.32
4366494-36649490.17791.10
5368716-36871690.72491.64
6365842-36584290.01790.94
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%
116.554034854038494028004016824022334028100.22
216.454074784071104072940.07
单位质量响应值RSD%判断
24338.9724759.511.22数据可信
供试品溶液-2K72SDB2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%
5min123463-234635.7355.478.945.735.468.93
224071-240715.8845.88
323124-231245.6525.65
423744-237445.8045.80
520558-205585.0255.02
619191-191914.6914.69
10min170090-7009017.13216.783.5017.1416.793.51
271514-7151417.48017.49
367519-6751916.50316.51
470107-7010717.13617.15
567817-6781716.57616.58
664845-6484515.85015.86
15min1103796-10379625.37025.112.4025.4125.152.39
2106397-10639726.00626.04
3102398-10239825.02925.07
4103406-10340625.27525.31
5101438-10143824.79424.83
699063-9906324.21324.25
20min1129588-12958831.67531.341.6731.7531.421.67
2131465-13146532.13332.22
3127916-12791631.26631.34
4128214-12821431.33931.42
5126676-12667630.96331.04
6125417-12541730.65530.73
30min1166935-16693540.80340.661.5240.9440.791.52
2170215-17021541.60541.74
3165541-16554140.46240.59
4167528-16752840.94841.08
5162870-16287039.80939.94
6164900-16490040.30640.43
45min1212882-21288252.03451.341.3652.2351.541.37
2213892-21389252.28052.49
3207272-20727250.66250.86
4210621-21062151.48151.68
5208183-20818350.88551.08
6207510-20751050.72150.91
60min1245679-24567960.05059.351.1560.3459.641.15
2245911-24591160.10760.40
3238407-23840758.27358.56
4242293-24229359.22259.51
5242997-24299759.39459.67
6241688-24168859.07559.35
90min1287246-28724670.21069.460.9670.6069.850.97
2287462-28746270.26370.66
3280755-28075568.62369.00
4283857-28385769.38269.77
5283863-28386369.38369.76
6281997-28199768.92769.30
120min1317279-31727977.55176.281.8578.0676.781.84
2317907-31790777.70478.21
3302179-30217973.86074.35
4309778-30977875.71776.22
5312377-31237776.35376.85
6312859-31285976.47076.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1347009-34700984.81883.971.6185.4584.601.60
2350353-35035385.63586.27
3334255-33425581.70082.32
4341188-34118883.39584.02
5344615-34461584.23284.85
6343819-34381984.03884.66
240min1365635-36563589.37087.951.5490.1588.721.54
2363489-36348988.84689.63
3350379-35037985.64186.39
4356682-35668287.18287.95
5362152-36215288.51989.28
6360713-36071388.16788.93
极限1368809-36880990.14689.011.2691.0789.921.26
2369327-36932790.27391.20
3357708-35770887.43388.33
4360324-36032488.07288.98
5364547-36454789.10490.01
6364140-36414089.00589.91
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%
116.554054584056924056914064374055894057730.10
216.454067584061874064720.10
单位质量响应值RSD%判断
24518.0124709.540.56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%
5min131692-316927.7268.014.227.738.014.20
232190-321907.8477.85
331078-310787.5767.58
434057-340578.3028.30
533613-336138.1948.19
634481-344818.4058.41
10min166750-6675016.27216.332.5716.2816.342.57
265431-6543115.95015.96
364709-6470915.77415.79
467368-6736816.42216.44
568648-6864816.73416.75
669037-6903716.82916.84
15min191436-9143622.28922.711.5222.3322.751.53
291615-9161522.33322.37
393382-9338222.76422.80
493330-9333022.75122.79
594247-9424722.97523.02
694996-9499623.15723.20
20min1111542-11154227.19127.721.5327.2727.801.53
2113188-11318827.59227.67
3112302-11230227.37627.45
4113845-11384527.75227.83
5115207-11520728.08428.16
6116118-11611828.30628.39
30min1143096-14309634.88235.290.7635.0035.410.76
2144436-14443635.20935.33
3144303-14430335.17735.30
4145087-14508735.36835.49
5146295-14629535.66235.79
6145371-14537135.43735.56
45min1176546-17654643.03743.480.6943.2243.660.70
2178509-17850943.51543.70
3177342-17734243.23143.41
4178620-17862043.54243.73
5179943-17994343.86544.05
6179164-17916443.67543.86
60min1202249-20224949.30249.840.7649.5550.090.76
2204513-20451349.85450.11
3203680-20368049.65149.90
4204428-20442849.83350.09
5204812-20481249.92750.19
6206938-20693850.44550.70
90min1235500-23550057.40857.880.5057.7458.220.50
2237014-23701457.77758.11
3237118-23711857.80258.14
4238070-23807058.03458.37
5238857-23885758.22658.57
6238123-23812358.04758.39
120min1262035-26203563.87664.040.7864.3164.480.78
2261919-26191963.84864.28
3259776-25977663.32563.76
4263499-26349964.23364.67
5265890-26589064.81665.26
6263182-26318264.15664.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1290792-29079270.88671.270.3271.4271.820.32
2292922-29292271.40571.95
3292307-29230771.25671.79
4293568-29356871.56372.11
5292249-29224971.24171.79
6292456-29245671.29271.84
240min1307907-30790775.05875.710.9675.7176.370.96
2307818-30781875.03775.70
3308765-30876575.26875.92
4311609-31160975.96176.62
5315295-31529576.85977.53
6312090-31209076.07876.74
极限1312610-31261076.20576.730.4276.9877.520.42
2314401-31440176.64177.43
3316315-31631577.10877.89
4314392-31439276.63977.43
5315228-31522876.84377.64
6315739-31573976.96877.76
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