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%
116.514022014024384018394019364018824020590.07
216.494025064025334025200.01
单位质量响应值RSD%判断
24352.4524409.950.17数据可信
供试品溶液-1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%
5min135143-351438.6488.938.698.658.938.68
240835-4083510.04910.05
331479-314797.7477.75
436628-366289.0149.01
538220-382209.4069.41
635465-354658.7288.73
10min184944-8494420.90421.176.9220.9221.186.93
295640-9564023.53623.55
379082-7908219.46119.47
483470-8347020.54120.56
590259-9025922.21222.23
682732-8273220.36020.37
15min1123438-12343830.37730.613.8330.4330.663.83
2131297-13129732.31132.37
3118697-11869729.21029.26
4122561-12256130.16130.21
5128846-12884631.70831.76
6121441-12144129.88629.93
20min1152485-15248537.52537.763.3037.6337.863.31
2161267-16126739.68639.80
3148096-14809636.44536.54
4150532-15053237.04537.14
5157842-15784238.84438.95
6150441-15044137.02237.12
30min1190227-19022746.81346.942.7446.9847.102.75
2198191-19819148.77348.95
3186598-18659845.92046.07
4184997-18499745.52645.69
5195798-19579848.18448.35
6188540-18854046.39846.56
45min1227362-22736255.95256.391.5856.1956.641.59
2234350-23435057.67257.93
3227337-22733755.94656.18
4226656-22665655.77856.02
5233141-23314157.37457.62
6226047-22604755.62855.87
60min1253689-25368962.43162.761.3762.7663.101.38
2259443-25944363.84764.20
3255611-25561162.90463.23
4251350-25135061.85562.19
5258602-25860263.64063.99
6251485-25148561.88862.22
90min1289099-28909971.14571.030.8371.5871.470.84
2290966-29096671.60472.06
3288240-28824070.93371.36
4285286-28528670.20670.64
5291409-29140971.71372.17
6286703-28670370.55570.99
120min1309779-30977976.23476.250.8576.7976.810.86
2310772-31077276.47877.06
3310648-31064876.44877.00
4306687-30668775.47376.02
5313886-31388677.24577.82
6307227-30722775.60676.16
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1321445-32144579.10578.690.5979.7979.380.60
2320382-32038278.84379.55
3318847-31884778.46679.14
4316637-31663777.92278.60
5321703-32170379.16879.87
6319534-31953478.63579.31
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%
116.514004214006094005474003134002324004240.04
216.494019464022174020820.05
单位质量响应值RSD%判断
24253.4224383.380.38数据可信
供试品溶液-1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%
5min149091-4909112.11216.0917.7512.1116.0917.75
257981-5798114.30614.31
361807-6180715.25015.25
468115-6811516.80616.81
582325-8232520.31220.31
671862-7186217.73017.73
10min1103890-10389025.63329.589.0425.6529.619.05
2113575-11357528.02228.05
3117382-11738228.96128.99
4122119-12211930.13030.16
5134695-13469533.23333.27
6127683-12768331.50331.53
15min1146371-14637136.11439.345.5736.1839.425.58
2152919-15291937.72937.80
3157784-15778438.93039.00
4162796-16279640.16640.24
5170014-17001441.94742.04
6166870-16687041.17241.25
20min1174918-17491843.15746.164.5643.2846.314.57
2181307-18130744.73444.87
3185075-18507545.66345.80
4189100-18910046.65646.80
5198303-19830348.92749.09
6193947-19394747.85248.00
30min1213519-21351952.68154.933.0152.8855.163.02
2217962-21796253.77753.99
3221235-22123554.58554.80
4223063-22306355.03655.26
5231832-23183257.20057.44
6228307-22830756.33056.56
45min1248810-24881061.38963.142.2961.6763.452.31
2252590-25259062.32162.62
3252498-25249862.29862.60
4256335-25633563.24563.56
5264550-26455065.27265.61
6260766-26076664.33864.66
60min1272960-27296067.34768.601.6867.7369.011.70
2274771-27477167.79468.20
3276015-27601568.10168.51
4276952-27695268.33268.75
5284819-28481970.27370.72
6282626-28262669.73270.16
90min1302808-30280874.71175.421.0375.2175.951.05
2304390-30439075.10275.62
3304205-30420575.05675.58
4303807-30380774.95875.49
5311144-31114476.76877.33
6307633-30763375.90276.45
120min1319282-31928278.77679.420.9079.4080.070.92
2321811-32181179.40080.04
3322000-32200079.44780.09
4318179-31817978.50479.16
5325944-32594480.42081.11
6324019-32401979.94580.62
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1330273-33027381.48881.310.7282.2482.100.73
2327052-32705280.69381.47
3329070-32907081.19181.97
4326902-32690280.65681.45
5332897-33289782.13582.96
6331165-33116581.70882.52
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%
116.512016392015532012332012462014042014150.09
216.492032182036322034250.15
单位质量响应值RSD%判断
12199.5812336.260.79数据可信
供试品溶液-2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%
5min120080-200809.8219.624.229.829.624.20
219498-194989.5369.54
319961-199619.7639.76
418064-180648.8358.84
520050-200509.8069.81
620322-203229.9399.94
10min145701-4570122.35221.432.8522.3721.452.86
243561-4356121.30521.32
344454-4445421.74221.76
441903-4190320.49520.51
543483-4348321.26721.28
643840-4384021.44221.46
15min165037-6503731.80931.141.6231.8631.191.62
264430-6443031.51231.56
363352-6335230.98531.04
462057-6205730.35230.40
563292-6329230.95631.01
663841-6384131.22431.28
20min180156-8015639.20438.841.0239.3138.941.02
280226-8022639.23839.34
379363-7936338.81638.92
478316-7831638.30438.40
578580-7858038.43338.54
679788-7978839.02439.13
30min1101634-10163449.70949.481.8949.8849.651.89
2104332-10433251.02851.20
399631-9963148.72948.90
4100692-10069249.24849.41
598923-9892348.38348.55
6101799-10179949.78949.96
45min1124688-12468860.98460.851.3261.2461.101.32
2127142-12714262.18562.44
3122426-12242659.87860.13
4123558-12355860.43260.68
5123558-12355860.43260.68
6125056-12505661.16461.42
60min1139633-13963368.29468.691.4468.6569.051.44
2143526-14352670.19870.56
3140405-14040568.67169.02
4139054-13905468.01168.36
5138043-13804367.51667.87
6142044-14204469.47369.83
90min1158562-15856277.55277.931.5178.0278.401.51
2162385-16238579.42279.90
3156283-15628376.43776.90
4159256-15925677.89178.35
5157660-15766077.11177.57
6161921-16192179.19579.66
120min1169008-16900882.66183.701.4183.2684.301.40
2174364-17436485.28185.89
3169577-16957782.93983.53
4171298-17129883.78184.37
5168930-16893082.62383.21
6173678-17367884.94585.55
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1175629-17562985.89986.441.4986.6487.181.48
2179783-17978387.93188.68
3174671-17467185.43186.16
4176150-17615086.15486.88
5173998-17399885.10285.83
6180158-18015888.11488.86
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%
116.512016792017352017432016612010342015700.15
216.492022772022482022620.02
单位质量响应值RSD%判断
12208.9612265.740.33数据可信
供试品溶液-2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%
5min142530-4253020.85321.545.0020.8521.545.00
247369-4736923.22523.23
344701-4470121.91721.92
444321-4432121.73121.73
543809-4380921.48021.48
640849-4084920.02820.03
10min175670-7567037.10137.631.9237.1437.671.92
275974-7597437.25037.29
378152-7815238.31838.35
477679-7767938.08638.12
578261-7826138.37238.41
674760-7476036.65536.69
15min197541-9754147.82548.171.8347.9248.271.82
295546-9554646.84746.95
3100202-10020249.13049.23
498489-9848948.29048.39
5100195-10019549.12649.23
697519-9751947.81447.91
20min1111096-11109654.47155.831.5454.6556.021.53
2113415-11341555.60855.79
3114290-11429056.03756.22
4115125-11512556.44656.63
5116135-11613556.94257.12
6113201-11320155.50355.68
30min1132364-13236464.89965.590.9265.1765.860.92
2133670-13367065.53965.81
3134595-13459565.99366.27
4133353-13335365.38465.66
5135722-13572266.54566.82
6132886-13288665.15565.42
45min1150342-15034273.71374.540.6174.0974.920.61
2152178-15217874.61474.99
3152725-15272574.88275.27
4151724-15172474.39174.77
5152650-15265074.84575.23
6152604-15260474.82275.20
60min1162156-16215679.50680.320.6880.0080.820.67
2164275-16427580.54581.05
3164307-16430780.56181.07
4163221-16322180.02880.54
5163511-16351180.17080.68
6165373-16537381.08381.58
90min1176488-17648886.53386.900.6187.1687.540.61
2178666-17866687.60188.24
3176869-17686986.72087.36
4176275-17627586.42887.07
5176542-17654286.55987.21
6178529-17852987.53488.17
120min1179918-17991888.21589.781.1888.9990.561.18
2185363-18536390.88491.67
3182719-18271989.58890.38
4182800-18280089.62890.41
5182118-18211889.29390.08
6185713-18571391.05691.84
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1185670-18567091.03591.460.9291.9692.400.91
2188389-18838992.36893.30
3185576-18557690.98991.93
4185026-18502690.71991.65
5185559-18555990.98091.92
6189060-18906092.69793.63
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