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%
112.813284743259183243493269233269283265180.47
212.853225493205993215740.43
单位质量响应值RSD%判断
25489.3125025.211.30数据可信
供试品溶液-2025030122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%
5min1358448-35844899.36598.201.7799.3798.201.78
2357926-35792699.22199.22
3347420-34742096.30896.31
4360335-36033599.88999.89
5356034-35603498.69698.70
6345386-34538695.74595.74
10min1358420-35842099.35899.570.6799.5299.730.67
2360055-36005599.81199.98
3359875-35987599.76199.92
4361617-361617100.244100.41
5360363-36036399.896100.06
6354765-35476598.34498.50
15min1361685-361685100.26399.670.75100.59100.000.75
2360233-36023399.860100.19
3358571-35857199.40099.73
4362929-362929100.608100.94
5358465-35846599.37099.70
6355390-35539098.51898.84
20min1362010-362010100.35399.440.79100.8599.940.80
2358683-35868399.43199.93
3358876-35887699.48499.98
4360727-36072799.997100.50
5358274-35827499.31799.81
6353727-35372798.05798.54
30min1357925-35792599.22099.370.9999.89100.030.99
2361501-361501100.212100.88
3358808-35880899.465100.12
4362932-362932100.608101.28
5356360-35636098.78799.45
6353167-35316797.90198.55
45min1362422-362422100.46799.690.94101.30100.520.94
2359752-35975299.727100.56
3357161-35716199.00999.83
4363045-363045100.640101.48
5361108-361108100.103100.93
6354258-35425898.20499.02
极限1363046-363046100.64099.800.70101.64100.790.70
2360231-36023199.860100.86
3359301-35930199.602100.59
4362776-362776100.565101.57
5357414-35741499.079100.07
6357329-35732999.055100.03
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%
112.813221303221403230603199103229393220360.40
212.853217843223123220480.12
单位质量响应值RSD%判断
25139.4225062.100.22数据可信
供试品溶液-2025030222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%
5min1347768-34776896.99896.771.2197.0096.771.21
2353532-35353298.60698.61
3346268-34626896.58096.58
4345203-34520396.28396.28
5348221-34822197.12497.12
6340781-34078195.04995.05
10min1353618-35361898.63098.691.1198.7998.861.11
2361432-361432100.809100.97
3352170-35217098.22698.39
4350495-35049597.75997.92
5353674-35367498.64598.81
6351693-35169398.09398.25
15min1354528-35452898.88398.611.0099.2198.941.00
2359882-359882100.377100.71
3351310-35131097.98698.31
4350085-35008597.64497.97
5353823-35382398.68799.01
6351670-35167098.08698.41
20min1354161-35416198.78198.591.0699.2799.081.06
2359635-359635100.308100.81
3349157-34915797.38597.87
4352178-35217898.22898.71
5355032-35503299.02499.51
6350627-35062797.79598.28
30min1354245-35424598.80498.761.0399.4699.411.04
2361147-361147100.730101.40
3353073-35307398.47899.13
4352143-35214398.21898.87
5353005-35300598.45999.11
6350840-35084097.85598.50
45min1355546-35554699.16798.931.1699.9999.741.16
2361155-361155100.732101.57
3350587-35058797.78498.60
4353017-35301798.46299.28
5357072-35707299.593100.41
6350689-35068997.81398.62
极限1350969-35096997.89199.091.3598.88100.071.34
2363675-363675101.435102.44
3352511-35251198.32199.30
4353780-35378098.67599.65
5358024-35802499.858100.84
6352604-35260498.34799.32
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%
112.813202383193683213553202613212973205040.26
212.853211103191473201280.44
单位质量响应值RSD%判断
25019.8324912.680.31数据可信
供试品溶液-2025030322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%
5min1330550-33055092.69292.692.0592.6992.692.05
2335598-33559894.10894.11
3325638-32563891.31591.32
4329655-32965592.44192.44
5321409-32140990.12990.13
6340320-34032095.43295.43
10min1342037-34203795.91496.110.9996.0796.270.98
2342034-34203495.91396.07
3342898-34289896.15596.31
4337478-33747894.63594.79
5347807-34780797.53297.68
6344232-34423296.52996.69
15min1343322-34332296.27496.330.9896.5996.640.97
2341372-34137295.72796.04
3344311-34431196.55196.86
4339382-33938295.16995.48
5349296-34929697.94998.26
6343425-34342596.30396.62
20min1344550-34455096.61896.401.1897.0996.871.18
2342422-34242296.02296.50
3345770-34577096.96097.43
4336619-33661994.39494.86
5348562-34856297.74398.22
6344656-34465696.64897.13
30min1345627-34562796.92096.770.7797.5697.400.78
2343445-34344596.30896.94
3345474-34547496.87797.51
4341121-34112195.65796.28
5349076-34907697.88898.53
6345800-34580096.96997.61
45min1347519-34751997.45197.011.0798.2597.811.06
2341763-34176395.83796.63
3346708-34670897.22398.02
4342630-34263096.08096.87
5351881-35188198.67499.48
6345247-34524796.81497.62
极限1349003-34900397.86797.820.8598.8398.780.85
2347063-34706397.32398.28
3351290-35129098.50899.47
4343977-34397796.45897.40
5349738-34973898.07399.04
6351921-35192198.68599.65
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