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%
1 16.453972254008123976633977834003863987740.43
2 16.524009263986253997760.41
单位质量响应值RSD%判断
24241.5824199.520.13数据可信
供试品溶液-3F70SDB1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%
5min139699-396999.8349.418.709.839.418.70
231335-313357.7627.76
338593-385939.5609.56
439552-395529.7989.80
539977-399779.9039.90
638729-387299.5949.59
10min183122-8312220.59120.173.6220.6120.183.63
275592-7559218.72618.74
381538-8153820.19920.21
483277-8327720.63020.65
583148-8314820.59820.61
681739-8173920.24920.26
15min1116154-11615428.77428.552.4028.8228.602.40
2109814-10981427.20427.25
3115397-11539728.58728.64
4117278-11727829.05329.10
5117095-11709529.00729.06
6115809-11580928.68928.74
20min1144671-14467135.83835.742.1235.9435.832.11
2138486-13848634.30634.40
3144476-14447635.79035.89
4147603-14760336.56536.66
5145228-14522835.97636.08
6145070-14507035.93736.03
30min1184443-18444345.69146.241.8745.8546.401.87
2181239-18123944.89745.04
3186074-18607446.09546.25
4190468-19046847.18347.34
5189697-18969746.99247.15
6188141-18814146.60746.76
45min1229804-22980456.92857.321.4457.1657.551.44
2226128-22612856.01756.24
3230945-23094557.21157.44
4231708-23170857.40057.64
5234996-23499658.21458.45
6234768-23476858.15858.39
60min1259916-25991664.38765.461.4564.7265.791.45
2259350-25935064.24764.56
3264454-26445465.51265.84
4265911-26591165.87266.21
5268245-26824566.45166.79
6267562-26756266.28166.61
90min1300330-30033074.39975.851.6074.8476.281.60
2301265-30126574.63075.05
3305656-30565675.71876.16
4306631-30663175.96076.40
5312722-31272277.46977.91
6310441-31044176.90477.35
120min1329713-32971381.67882.411.6282.2482.981.62
2325597-32559780.65881.20
3329928-32992881.73182.30
4334342-33434282.82483.40
5340707-34070784.40184.98
6335843-33584383.19683.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1350698-35069886.87689.481.8487.5790.181.83
2359968-35996889.17389.85
3358237-35823788.74489.44
4366559-36655990.80591.51
5369524-36952491.54092.25
6362359-36235989.76590.47
240min1373106-37310692.42793.411.2193.2794.261.21
2377096-37709693.41694.24
3370639-37063991.81692.66
4379073-37907393.90594.77
5383160-38316094.91895.79
6379249-37924993.94994.81
极限1377832-37783293.59894.111.0294.5995.121.02
2376213-37621393.19794.18
3375788-37578893.09294.09
4382120-38212094.66095.68
5385307-38530795.45096.48
6382132-38213294.66395.68
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%
1 16.454015763991154020144017473990244006950.38
2 16.524029504013514021500.29
单位质量响应值RSD%判断
24358.3624343.220.05数据可信
供试品溶液-3F70SDB1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%
5min140029-400299.8639.621.519.869.621.48
238904-389049.5869.59
339468-394689.7259.72
438424-384249.4689.47
538874-388749.5789.58
638666-386669.5279.53
10min183437-8343720.55920.381.3920.5820.401.40
280502-8050219.83619.85
383555-8355520.58820.60
483359-8335920.54020.56
582851-8285120.41420.43
682567-8256720.34420.36
15min1116967-11696728.82128.822.4128.8728.872.41
2113259-11325927.90727.96
3121897-12189730.03530.09
4116767-11676728.77128.82
5117174-11717428.87228.92
6115720-11572028.51328.56
20min1144733-14473335.66235.351.1135.7635.451.10
2140627-14062734.65034.75
3143235-14323535.29335.39
4144785-14478535.67535.77
5144406-14440635.58135.68
6142980-14298035.23035.33
30min1186476-18647645.94745.770.6846.1145.930.69
2183223-18322345.14645.30
3185919-18591945.81045.97
4186446-18644645.94046.10
5186452-18645245.94246.10
6185963-18596345.82145.98
45min1233328-23332857.49257.151.3657.7357.391.36
2225825-22582555.64355.87
3232162-23216257.20457.44
4232241-23224157.22457.46
5233493-23349357.53257.77
6234673-23467357.82358.06
60min1265490-26549065.41665.130.9665.7565.460.96
2259178-25917863.86164.18
3265460-26546065.40965.74
4265289-26528965.36765.70
5265072-26507265.31365.64
6265479-26547965.41465.74
90min1305788-30578875.34675.550.8375.7975.990.83
2302532-30253274.54374.97
3308143-30814375.92676.37
4305421-30542175.25575.69
5309219-30921976.19176.63
6308604-30860476.04076.48
120min1326827-32682780.53082.391.3881.0982.961.38
2331221-33122181.61282.16
3337238-33723883.09583.66
4334519-33451982.42582.99
5338733-33873383.46384.03
6337808-33780883.23583.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1367840-36784090.63590.530.5691.3391.230.56
2365018-36501889.94090.63
3368634-36863490.83191.54
4364800-36480089.88690.59
5368378-36837890.76891.47
6369822-36982291.12491.83
240min1382464-38246494.23993.880.7395.0994.730.72
2378637-37863793.29694.13
3383760-38376094.55895.41
4379269-37926993.45194.30
5377820-37782093.09493.95
6384071-38407194.63595.49
极限1388203-38820395.65394.950.7996.6695.960.78
2380304-38030493.70694.70
3384499-38449994.74095.75
4384399-38439994.71595.72
5388383-38838395.69796.71
6386294-38629495.18296.20
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%
1 16.454035974087074048854085974028894057350.68
2 16.524036064015874025960.36
单位质量响应值RSD%判断
24664.7424370.220.85数据可信
供试品溶液-3F70SDB1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%
5min152667-5266712.88913.173.5012.8913.173.49
251896-5189612.70112.70
356565-5656513.84313.84
453330-5333013.05213.05
555696-5569613.63113.63
652665-5266512.88912.89
10min1102316-10231625.04025.431.4825.0625.461.48
2103005-10300525.20925.23
3106557-10655726.07826.10
4104763-10476325.63925.66
5103074-10307425.22625.25
6103847-10384725.41525.44
15min1143608-14360835.14635.611.5335.2135.671.52
2144739-14473935.42235.49
3149543-14954336.59836.66
4145965-14596535.72235.79
5145588-14558835.63035.69
6143544-14354435.13035.19
20min1178036-17803643.57143.280.8043.6943.410.79
2175270-17527042.89443.02
3178824-17882443.76443.89
4176526-17652643.20243.33
5177038-17703843.32743.45
6175497-17549742.95043.07
30min1216960-21696053.09753.551.1453.2953.741.14
2217856-21785653.31653.51
3221604-22160454.23454.43
4218066-21806653.36853.56
5222177-22217754.37454.57
6216175-21617552.90553.10
45min1255513-25551362.53263.110.9862.8263.400.98
2257614-25761463.04663.33
3262520-26252064.24764.54
4256448-25644862.76163.05
5258566-25856663.27963.57
6256608-25660862.80063.08
60min1281653-28165368.93069.961.1369.3270.351.13
2288826-28882670.68571.07
3289951-28995170.96071.36
4284782-28478269.69570.08
5286801-28680170.18970.58
6283249-28324969.32069.71
90min1317464-31746477.69478.510.8778.2079.020.87
2321695-32169578.72979.23
3325515-32551579.66480.18
4318786-31878678.01778.52
5320822-32082278.51579.02
6320517-32051778.44178.94
120min1335884-33588482.20283.300.9382.8383.930.93
2340887-34088783.42684.06
3345277-34527784.50085.15
4340051-34005183.22183.86
5341505-34150583.57784.22
6338522-33852282.84783.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1361605-36160588.49688.450.2889.2689.230.28
2360893-36089388.32289.10
3362105-36210588.61989.41
4361020-36102088.35389.13
5362855-36285588.80289.58
6360035-36003588.11288.88
240min1375435-37543591.88191.491.0692.8092.411.05
2375168-37516891.81692.74
3374428-37442891.63592.57
4366046-36604689.58390.50
5377218-37721892.31793.24
6374609-37460991.67992.60
极限1374116-37411691.55891.500.6892.6392.580.68
2371975-37197591.03492.11
3378153-37815392.54693.64
4371707-37170790.96992.04
5375268-37526891.84092.92
6372054-37205491.05492.12
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