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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.431986191987861986721984391983891985810.09
212.461989521992701991110.12
单位质量响应值RSD%判断
15975.9515980.020.02数据可信
供试品溶液-25020501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%
5min1149378-14937875.38971.333.3575.3971.333.35
2137887-13788769.58969.59
3136535-13653568.90768.91
4144249-14424972.80072.80
5139891-13989170.60170.60
6140072-14007270.69270.69
10min1170452-17045286.02483.893.0486.1484.003.04
2162392-16239281.95782.06
3159943-15994380.72180.82
4170880-17088086.24086.35
5170879-17087986.24086.35
6162823-16282382.17482.28
15min1173804-17380487.71685.892.9887.9686.122.98
2166303-16630383.93184.16
3164122-16412282.83083.05
4174922-17492288.28088.52
5175416-17541688.53088.77
6166513-16651384.03784.27
20min1174626-17462688.13187.022.5988.5087.382.59
2169111-16911185.34885.70
3167041-16704184.30384.65
4177136-17713689.39889.77
5177251-17725189.45689.82
6169368-16936885.47785.83
30min1177265-17726589.46389.202.7389.9789.702.73
2173352-17335287.48887.97
3171420-17142086.51386.99
4181443-18144391.57192.08
5183403-18340392.56193.06
6173636-17363687.63188.11
45min1180385-18038591.03890.912.1591.6891.542.15
2175651-17565188.64889.26
3176845-17684589.25189.86
4184911-18491193.32293.96
5184443-18444393.08693.73
6178569-17856990.12190.74
60min1182971-18297192.34392.721.4193.1293.481.42
2179941-17994190.81391.56
3183049-18304992.38293.12
4187095-18709594.42495.21
5186215-18621593.98094.76
6183000-18300092.35793.11
极限1209171-209171105.565104.481.07106.48105.381.06
2206439-206439104.187105.07
3205211-205211103.567104.44
4206487-206487104.211105.13
5204614-204614103.266104.19
6210175-210175106.072106.96
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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.439929299488994349933899384993870.08
212.469875498634986940.09
单位质量响应值RSD%判断
7995.747920.870.67数据可信
供试品溶液-25020502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%
5min171260-7126072.20770.914.7572.2170.914.75
270910-7091071.85271.85
372189-7218973.14873.15
473001-7300173.97173.97
568611-6861169.52269.52
663909-6390964.75864.76
10min187476-8747688.63887.182.4288.7587.292.42
283149-8314984.25484.36
387286-8728688.44588.56
484099-8409985.21685.33
588462-8846289.63789.74
685770-8577086.90987.01
15min190353-9035391.55389.182.8291.7989.412.82
285157-8515786.28886.52
388594-8859489.77190.01
485123-8512386.25486.49
590915-9091592.12392.36
687897-8789789.06589.29
20min192485-9248593.71490.412.7294.0990.782.71
287186-8718688.34488.71
389144-8914490.32890.71
486244-8624487.39087.76
591539-9153992.75593.13
688757-8875789.93690.30
30min193866-9386695.11391.772.7295.6392.282.71
288071-8807189.24189.74
389916-8991691.11091.62
488267-8826789.44089.94
593227-9322794.46594.98
690057-9005791.25391.75
45min196392-9639297.67293.663.0798.3394.303.07
289098-8909890.28290.91
393095-9309594.33294.98
490079-9007991.27691.91
594818-9481896.07896.74
691108-9110892.31892.95
60min198880-98880100.19494.773.51101.0095.553.50
290122-9012291.31992.08
392832-9283294.06594.86
491574-9157492.79093.56
595988-9598897.26398.06
691753-9175392.97293.74
极限1105655-105655107.059101.213.76108.02102.143.75
295690-9569096.96197.86
398409-9840999.716100.65
499840-99840101.166102.08
5102798-102798104.164105.11
696903-9690398.19099.10
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