磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.173496243510783505593487543500853500200.26
213.243513103490933502020.45
单位质量响应值RSD%判断
26577.0726450.300.34数据可信
供试品溶液-2022030801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%
5min1363776-36377696.05693.672.7996.0693.672.79
2342680-34268090.48690.49
3367534-36753497.04897.05
4344912-34491291.07591.08
5353788-35378893.41993.42
6355670-35567093.91693.92
10min1373355-37335598.58697.861.3798.7598.021.37
2364393-36439396.21996.37
3373232-37323298.55398.71
4376744-37674499.48099.63
5371407-37140798.07198.23
6364594-36459496.27296.43
15min1372436-37243698.34398.351.5498.6798.671.54
2367208-36720896.96297.27
3374937-37493799.00399.33
4381119-381119100.636100.95
5373993-37399398.75499.07
6365195-36519596.43196.75
20min1373407-37340798.59998.981.2199.0999.461.21
2376756-37675699.48499.96
3374145-37414598.79499.29
4381586-381586100.759101.24
5375420-37542099.13199.61
6367722-36772297.09897.58
30min1371402-37140298.07098.501.2998.7299.151.29
2368323-36832397.25797.90
3374141-37414198.79399.45
4380053-380053100.354101.01
5376483-37648399.411100.06
6367726-36772697.09997.74
45min1374066-37406698.77398.481.4299.5999.291.42
2366768-36676896.84697.65
3373897-37389798.72999.55
4379006-379006100.078100.90
5377467-37746799.671100.49
6366456-36645696.76497.57
极限1375560-37556099.16899.061.63100.15100.031.62
2368070-36807097.19098.15
3376323-37632399.369100.35
4382108-382108100.897101.88
5380900-380900100.578101.56
6367917-36791797.15098.11
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.173514073499273502363510353495103504230.23
213.243498433488793493610.20
单位质量响应值RSD%判断
26607.6726386.780.59数据可信
供试品溶液-2022030801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%
5min1368297-36829797.31191.766.2397.3191.766.23
2351089-35108992.76592.76
3356640-35664094.23194.23
4312754-31275482.63682.64
5364870-36487096.40696.41
6330175-33017587.23987.24
10min1373630-37363098.72196.861.4498.8897.021.45
2359974-35997495.11295.27
3365248-36524896.50696.66
4362028-36202895.65595.79
5371338-37133898.11598.28
6367417-36741797.07997.22
15min1375157-37515799.12497.651.3599.4597.961.35
2360651-36065195.29195.60
3368150-36815097.27397.59
4372336-37233698.37998.68
5371046-37104698.03898.36
6370059-37005997.77798.08
20min1376127-37612799.38098.001.5799.8798.481.57
2360517-36051795.25695.73
3368557-36855797.38097.86
4375901-37590199.32199.78
5372267-37226798.36098.85
6372131-37213198.32498.79
30min1374910-37491099.05997.961.6599.7298.601.64
2360954-36095495.37196.00
3366108-36610896.73397.38
4377244-37724499.675100.30
5373432-37343298.66899.32
6371760-37176098.22698.86
45min1374239-37423998.88197.891.6099.7098.701.59
2359654-35965495.02895.82
3367945-36794597.21898.02
4375252-37525299.14999.94
5373908-37390898.79499.61
6371988-37198898.28799.08
极限1376267-37626799.41798.371.78100.4099.331.77
2361985-36198595.64496.59
3367011-36701196.97297.94
4377062-37706299.627100.59
5378966-378966100.130101.11
6372423-37242398.40299.36
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.173500113478493484283500373510643494780.38
213.243491813489343490580.06
单位质量响应值RSD%判断
26535.9126363.900.46数据可信
供试品溶液-2022030901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%
5min1356313-35631394.31392.417.0294.3192.417.02
2306253-30625381.06281.06
3334241-33424188.47188.47
4361475-36147595.67995.68
5369990-36999097.93397.93
6366484-36648497.00597.01
10min1365633-36563396.78097.632.1996.9497.782.20
2354544-35454493.84593.98
3373079-37307998.75198.90
4370228-37022897.99698.16
5377954-377954100.041100.20
6371557-37155798.34898.51
15min1366466-36646697.00098.101.3097.3298.421.30
2364978-36497896.60696.90
3374341-37434199.08599.40
4369576-36957697.82398.15
5377722-37772299.980100.31
6370729-37072998.12998.45
20min1367132-36713297.17798.641.2797.6699.121.27
2368830-36883097.62698.08
3375036-37503699.26999.75
4370592-37059298.09298.58
5379874-379874100.549101.05
6374522-37452299.13399.62
30min1367490-36749097.27198.400.9997.9199.050.99
2370086-37008697.95898.57
3374996-37499699.25899.90
4368932-36893297.65398.30
5376956-37695699.777100.44
6372156-37215698.50699.16
45min1366786-36678697.08598.621.1097.8999.421.10
2370711-37071198.12498.90
3376289-37628999.600100.41
4371451-37145198.32099.13
5378132-378132100.088100.92
6372064-37206498.48299.30
极限1368378-36837897.50698.901.2198.4799.881.22
2369772-36977297.87598.82
3377049-37704999.801100.78
4372479-37247998.59299.57
5380459-380459100.704101.70
6373802-37380298.94299.92
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.173478693473273480053478073473523476720.09
213.243515903501913508900.29
单位质量响应值RSD%判断
26398.7926502.270.28数据可信
供试品溶液-2022030901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%
5min1357957-35795794.74592.524.6194.7592.524.61
2321861-32186185.19185.19
3366101-36610196.90196.90
4357924-35792494.73694.74
5339758-33975889.92889.93
6353708-35370893.62193.62
10min1379988-379988100.57698.331.43100.7398.481.43
2365291-36529196.68696.83
3374681-37468199.17299.33
4371538-37153898.34098.50
5367238-36723897.20297.35
6370231-37023197.99498.15
15min1378459-378459100.17299.070.81100.5099.390.82
2373668-37366898.90499.21
3375066-37506699.27499.60
4376524-37652499.66099.98
5370201-37020197.98698.30
6371883-37188398.43198.75
20min1380927-380927100.82599.171.09101.3299.661.09
2374032-37403299.00099.47
3375748-37574899.45499.95
4375814-37581499.47299.96
5368445-36844597.52198.00
6373098-37309898.75399.24
30min1379750-379750100.51399.480.96101.17100.130.96
2376863-37686399.749100.38
3377136-37713699.822100.48
4378452-378452100.170100.82
5370686-37068698.11498.75
6372266-37226698.53299.18
45min1381212-381212100.90099.470.94101.73100.280.94
2376043-37604399.532100.33
3377116-37711699.816100.64
4376573-37657399.672100.49
5371961-37196198.45299.25
6371943-37194398.44799.26
极限1382172-382172101.154100.711.97102.15101.691.95
2375335-37533599.345100.31
3377164-37716499.829100.82
4376898-37689899.759100.75
5376413-37641399.630100.60
6394949-394949104.536105.51
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