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%
112.269942699401994669917099167993260.15
212.339993799839998880.07
单位质量响应值RSD%判断
8101.638101.220.01数据可信
供试品溶液-25032603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%
5min183710-8371083.07582.243.5683.0882.243.56
277771-7777177.18177.18
384599-8459983.95883.96
480948-8094880.33480.33
585307-8530784.66084.66
684903-8490384.25984.26
10min194841-9484194.12292.282.3194.2592.412.31
289507-8950788.82888.94
394621-9462193.90494.03
491292-9129290.60090.72
594291-9429193.57693.70
693379-9337992.67192.80
15min194881-9488194.16293.782.4294.4394.042.42
291118-9111890.42790.68
397340-9734096.60296.87
492639-9263991.93792.19
596191-9619195.46295.73
694826-9482694.10794.37
20min195706-9570694.98095.393.9095.3995.793.89
291611-9161190.91691.30
3102821-102821102.041102.45
494207-9420793.49393.89
596831-9683196.09796.51
695517-9551794.79395.20
30min197077-9707796.34195.262.0496.8995.802.05
292665-9266591.96292.48
397758-9775897.01797.58
494688-9468893.97094.50
597384-9738496.64697.20
696362-9636295.63196.18
45min198971-9897198.22197.151.4198.9197.841.42
295841-9584195.11495.77
399466-9946698.71299.42
496717-9671795.98496.66
598385-9838597.63998.34
697956-9795697.21397.91
60min1100162-10016299.40397.972.49100.2498.802.49
294982-9498294.26295.06
3102266-102266101.491102.35
497524-9752496.78597.60
598896-9889698.14698.99
698481-9848197.73498.57
极限1102779-102779102.000101.611.39102.99102.591.38
2102985-102985102.204103.15
3104327-104327103.536104.55
4102783-102783102.004102.97
5100709-10070999.945100.94
6100716-10071699.952100.94
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%
112.261994082001411997751993261996221996540.17
212.332010512007592009050.11
单位质量响应值RSD%判断
16284.9916294.000.04数据可信
供试品溶液-25032601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%
5min1165614-16561481.74279.534.0681.7479.544.06
2160402-16040279.17079.17
3171996-17199684.89284.89
4154761-15476176.38576.39
5156465-15646577.22677.23
6157605-15760577.78977.79
10min1177836-17783687.77487.222.8287.9087.332.82
2175911-17591186.82486.94
3185976-18597691.79291.92
4172272-17227285.02885.14
5175268-17526886.50786.62
6172959-17295985.36785.48
15min1180086-18008688.88588.362.5589.1488.612.55
2179036-17903688.36788.62
3187346-18734692.46892.73
4174718-17471886.23686.48
5177329-17732987.52487.77
6175579-17557986.66086.91
20min1181584-18158489.62488.632.5690.0189.022.57
2179165-17916588.43088.81
3187744-18774492.66593.07
4175260-17526086.50386.87
5177585-17758587.65188.03
6176123-17612386.92987.30
30min1184718-18471891.17189.982.7891.6990.502.78
2181070-18107089.37189.88
3191313-19131394.42694.97
4177573-17757387.64588.15
5180782-18078289.22989.74
6178405-17840588.05588.56
45min1184024-18402490.82990.762.5491.4991.412.55
2183185-18318590.41591.06
3192728-19272895.12595.81
4179004-17900488.35188.98
5182672-18267290.16190.80
6181685-18168589.67490.31
60min1186362-18636291.98392.093.3292.7892.873.31
2184514-18451491.07191.85
3198324-19832497.88798.71
4181951-18195189.80590.57
5186959-18695992.27793.05
6181334-18133489.50190.27
极限1204987-204987101.175102.281.34102.11103.211.35
2208926-208926103.120104.04
3211563-211563104.421105.39
4205297-205297101.328102.23
5208075-208075102.700103.62
6204546-204546100.958101.86
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%
112.261997421996841999381996962000691998260.09
212.332007522004892006200.10
单位质量响应值RSD%判断
16299.0216270.880.13数据可信
供试品溶液-25032602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%
5min1162370-16237080.16381.642.7180.1681.642.71
2167243-16724382.56982.57
3166418-16641882.16282.16
4163926-16392680.93280.93
5172548-17254885.18885.19
6159629-15962978.81078.81
10min1178966-17896688.35790.571.7888.4890.691.78
2185856-18585691.75991.88
3183511-18351190.60190.72
4183276-18327690.48590.61
5188063-18806392.84892.98
6180997-18099789.36089.48
15min1181544-18154489.63091.501.2089.8891.761.20
2187705-18770592.67192.93
3185527-18552791.59691.86
4184589-18458991.13391.39
5187304-18730492.47392.74
6185384-18538491.52691.78
20min1181774-18177489.74391.761.3890.1392.151.38
2189203-18920393.41193.81
3185933-18593391.79792.19
4185798-18579891.73092.12
5187706-18770692.67293.08
6184680-18468091.17891.57
30min1183252-18325290.47392.851.6590.9993.381.66
2190491-19049194.04794.59
3187962-18796292.79893.33
4186306-18630691.98192.51
5192052-19205294.81895.36
6188355-18835592.99293.52
45min1184864-18486491.26993.601.4691.9394.281.46
2192191-19219194.88695.57
3189249-18924993.43494.11
4188359-18835992.99493.66
5191976-19197694.78095.47
6190909-19090994.25394.92
60min1186199-18619991.92894.571.6392.7295.381.63
2193386-19338695.47696.30
3190993-19099394.29595.11
4190214-19021493.91094.72
5194291-19429195.92396.75
6194176-19417695.86696.67
极限1206685-206685102.042102.171.64102.97103.121.63
2208454-208454102.915103.88
3203474-203474100.457101.41
4209971-209971103.664104.61
5210617-210617103.983104.96
6202482-20248299.967100.92
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