达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312019172011612013952012862002532012020.31
212.292020562024452022500.14
单位质量响应值RSD%判断
16344.6016456.470.49数据可信
供试品溶液-2025041711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%
5min1168156-16815682.43682.261.7682.4482.261.76
2164788-16478880.78580.78
3170843-17084383.75383.75
4165680-16568081.22281.22
5165574-16557481.17081.17
6171722-17172284.18484.18
10min1186711-18671191.53291.751.2291.6691.881.22
2183201-18320189.81189.93
3188020-18802092.17492.30
4188123-18812392.22492.35
5186928-18692891.63891.76
6189997-18999793.14393.27
15min1192920-19292094.57695.000.8894.8495.270.88
2193214-19321494.72094.98
3193268-19326894.74695.01
4191784-19178494.01994.28
5195040-19504095.61595.87
6196544-19654496.35296.62
20min1196329-19632996.24796.720.9396.6597.120.93
2196695-19669596.42796.82
3195983-19598396.07796.48
4195570-19557095.87596.28
5199200-19920097.65598.06
6199967-19996798.03198.44
30min1200755-20075598.41798.690.9598.9699.240.94
2200396-20039698.24198.78
3198699-19869997.40997.96
4200946-20094698.51099.06
5203646-20364699.834100.38
6203401-20340199.714100.27
45min1203574-20357499.79999.481.13100.49100.181.12
2203364-20336499.696100.39
3200383-20038398.23498.93
4199933-19993398.01498.71
5205157-205157100.575101.27
6205172-205172100.582101.29
极限1204472-204472100.23999.351.31101.08100.201.30
2201232-20123298.65199.49
3199926-19992698.01098.85
4199805-19980597.95198.79
5205720-205720100.851101.70
6204795-204795100.397101.26
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312030132027292029202025282029142028210.10
212.292017642018402018020.03
单位质量响应值RSD%判断
16476.1216420.020.25数据可信
供试品溶液-2025041711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%
5min1164004-16400480.16781.841.8080.1781.841.80
2164142-16414280.23580.23
3171140-17114083.65583.66
4167452-16745281.85381.85
5167471-16747181.86281.86
6170402-17040283.29583.29
10min1186199-18619991.01691.451.0691.1491.581.05
2183561-18356189.72789.85
3188516-18851692.14992.27
4187443-18744391.62591.75
5187961-18796191.87892.00
6188859-18885992.31792.44
15min1192942-19294294.31294.920.9894.5795.180.98
2191786-19178693.74794.00
3196419-19641996.01296.28
4195725-19572595.67395.93
5192876-19287694.28094.54
6195351-19535195.49095.75
20min1196269-19626995.93996.300.9396.3496.700.93
2194537-19453795.09295.49
3198137-19813796.85297.26
4199742-19974297.63698.04
5195941-19594195.77896.18
6197442-19744296.51296.92
30min1199656-19965697.59498.110.8798.1498.660.87
2200243-20024397.88198.42
3200675-20067598.09298.65
4203926-20392699.682100.23
5198868-19886897.20997.75
6200890-20089098.19898.75
45min1202383-20238398.92798.741.3299.6299.441.32
2199003-19900397.27597.96
3201644-20164498.56699.27
4206921-206921101.146101.85
5201019-20101998.26198.95
6201058-20105898.28098.98
极限1200815-20081598.16198.761.3599.0099.611.35
2200048-20004897.78698.62
3202147-20214798.81299.66
4207432-207432101.395102.25
5200644-20064498.07798.92
6201221-20122198.35999.21
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