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%
116.457852127851477849027842097845137847970.06
216.527916937924757920840.07
单位质量响应值RSD%判断
47708.0247946.970.36数据可信
供试品溶液-3G80SDA2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%
5min144869-448695.6295.662.645.635.662.62
247301-473015.9345.93
343951-439515.5145.51
444933-449335.6375.64
545269-452695.6795.68
644216-442165.5475.55
10min1100794-10079412.64512.452.5612.6512.462.57
2103049-10304912.92812.94
397269-9726912.20312.21
497944-9794412.28712.30
5100059-10005912.55312.56
696230-9623012.07212.08
15min1152820-15282019.17218.422.8919.2018.462.87
2151284-15128418.97919.01
3144325-14432518.10618.14
4143393-14339317.98918.02
5146396-14639618.36618.40
6142898-14289817.92717.96
20min1195236-19523624.49323.403.0024.5623.463.00
2191472-19147224.02024.08
3183550-18355023.02723.09
4181364-18136422.75222.81
5185345-18534523.25223.31
6182223-18222322.86022.92
30min1255646-25564632.07130.433.2332.1730.523.22
2247964-24796431.10731.21
3236798-23679829.70729.80
4236612-23661229.68329.78
5241601-24160130.30930.41
6236609-23660929.68329.78
45min1315099-31509939.53037.962.6439.6938.112.64
2308724-30872438.73038.88
3296447-29644737.19037.34
4295350-29535037.05237.20
5302984-30298438.01038.16
6296717-29671737.22437.37
60min1357711-35771144.87543.352.2945.1043.562.30
2352148-35214844.17844.40
3339354-33935442.57342.78
4337916-33791642.39242.60
5345285-34528543.31743.53
6340693-34069342.74042.95
90min1393258-39325849.33549.771.3349.6350.061.32
2406183-40618350.95651.25
3394862-39486249.53649.82
4393061-39306149.31049.59
5399577-39957750.12850.41
6393458-39345849.36049.64
120min1435160-43516054.59254.451.1154.9754.821.11
2442262-44226255.48255.86
3430913-43091354.05954.42
4430016-43001653.94654.31
5435848-43584854.67855.05
6429976-42997653.94154.30
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1475427-47542759.64359.670.9160.1160.130.91
2479965-47996560.21260.68
3475402-47540259.64060.09
4473666-47366659.42259.87
5480656-48065660.29960.76
6468926-46892658.82859.28
240min1492026-49202661.72562.550.8262.3063.100.81
2501965-50196562.97263.54
3499525-49952562.66663.22
4496949-49694962.34362.89
5503368-50336863.14863.71
6497572-49757262.42162.97
300min1509321-50932163.89564.450.6364.5765.110.62
2516985-51698564.85765.53
3517843-51784364.96465.62
4513463-51346364.41565.07
5512454-51245464.28864.95
6512168-51216864.25264.91
360min1517623-51762364.93765.680.8365.7266.450.82
2528884-52888466.34967.13
3526088-52608865.99966.76
4524017-52401765.73966.50
5525480-52548065.92266.70
6519097-51909765.12265.88
极限1519452-51945265.16665.891.0266.0566.771.00
2529925-52992566.48067.37
3530248-53024866.52067.40
4526728-52672866.07966.95
5517777-51777764.95665.84
6527039-52703966.11866.99
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%
116.457908357908307913297909077910027909810.03
216.527957157956587956860.01
单位质量响应值RSD%判断
48083.9548165.010.12数据可信
供试品溶液-3G80SDA2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%
5min147850-478505.9665.604.675.975.604.67
245578-455785.6835.68
346337-463375.7775.78
443852-438525.4675.47
541925-419255.2275.23
644020-440205.4885.49
10min1100754-10075412.56212.203.7712.5712.213.75
2101710-10171012.68112.69
399404-9940412.39312.40
498591-9859112.29212.30
592614-9261411.54711.56
694068-9406811.72811.74
15min1149674-14967418.66117.982.9318.6918.012.92
2147395-14739518.37718.41
3145515-14551518.14218.17
4143738-14373817.92117.95
5138347-13834717.24917.28
6140683-14068317.54017.57
20min1191275-19127523.84823.062.4223.9123.122.43
2187894-18789423.42623.49
3183801-18380122.91622.98
4186552-18655223.25923.32
5179917-17991722.43122.49
6180281-18028122.47722.53
30min1249667-24966731.12829.862.6031.2329.962.60
2241232-24123230.07630.18
3240500-24050029.98530.08
4238756-23875629.76729.87
5230936-23093628.79228.89
6236046-23604629.42929.52
45min1310444-31044438.70537.362.3038.8637.512.30
2303001-30300137.77737.93
3299758-29975837.37337.52
4299314-29931437.31737.47
5290167-29016736.17736.32
6295314-29531436.81936.96
60min1352745-35274543.97942.661.9844.2042.881.98
2345873-34587343.12243.34
3344730-34473042.98043.19
4337358-33735842.06142.27
5335147-33514741.78541.99
6337344-33734442.05942.26
90min1405321-40532150.53449.401.6350.8349.681.64
2400942-40094249.98850.27
3398737-39873749.71350.00
4392737-39273748.96549.25
5388930-38893048.49148.76
6390681-39068148.70948.98
120min1441577-44157755.05453.961.5555.4354.331.55
2434609-43460954.18654.55
3438498-43849854.67155.04
4428512-42851253.42553.79
5423525-42352552.80453.16
6430161-43016153.63153.99
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1484732-48473260.43558.871.7760.9059.321.76
2477512-47751259.53559.99
3466820-46682058.20258.66
4461352-46135257.52057.97
5468690-46869058.43558.88
6473856-47385659.07959.53
240min1502226-50222662.61662.201.1763.1862.751.17
2502188-50218862.61163.17
3505823-50582363.06463.62
4498884-49888462.19962.75
5490669-49066961.17561.71
6493313-49331361.50562.05
300min1518206-51820664.60864.091.4365.2864.741.43
2520872-52087264.94165.60
3522566-52256665.15265.81
4506102-50610263.09963.75
5508987-50898763.45964.10
6507350-50735063.25563.90
360min1528920-52892065.94465.451.8766.7266.211.86
2527289-52728965.74166.51
3539880-53988067.31068.08
4525060-52506065.46366.22
5516261-51626164.36665.11
6512325-51232563.87564.63
极限1531290-53129066.24065.701.4767.1366.581.47
2527476-52747665.76466.64
3537387-53738767.00067.88
4528764-52876465.92566.79
5514953-51495364.20365.06
6522053-52205365.08865.95
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