二甲双胍恩格列净片项目信息
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.209723297141972229737596963971870.16
210.109470494412945580.22
单位质量响应值RSD%判断
9528.149362.181.25数据可信
供试品溶液-2024092321批-恩格列净-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%
5min136335-3633534.27542.1022.8234.2842.1022.82
235633-3563333.61333.61
342956-4295640.52140.52
440107-4010737.83437.83
550461-5046147.60147.60
662276-6227658.74658.75
10min177691-7769173.28778.739.6973.3478.809.70
274219-7421970.01270.07
381769-8176977.13477.20
480481-8048175.91975.98
592266-9226687.03687.12
694357-9435789.00989.11
15min197733-9773392.19391.461.2492.3791.661.24
295238-9523889.84090.01
397013-9701391.51491.71
497828-9782892.28392.47
598146-9814692.58392.81
695750-9575090.32390.57
20min199178-9917893.55693.572.4693.8993.922.43
298645-9864593.05493.38
3103593-10359397.72198.07
498890-9889093.28593.63
598761-9876193.16393.54
696090-9609090.64391.04
30min1100030-10003094.36093.201.2494.8593.711.21
299369-9936993.73794.21
398620-9862093.03093.54
499589-9958993.94494.44
598639-9863993.04893.58
696579-9657991.10591.65
45min1106726-106726100.67794.153.55101.3294.823.51
299007-9900793.39594.03
398684-9868493.09093.76
499406-9940693.77194.43
598559-9855992.97293.66
696465-9646590.99791.70
60min1101129-10112995.39793.291.4596.2194.111.43
298575-9857592.98893.78
399341-9934193.71094.53
499065-9906593.45094.26
598578-9857892.99093.83
696701-9670191.22092.07
极限1102133-10213396.34495.181.1197.3296.161.08
2101559-10155995.80296.75
3101197-10119795.46196.44
4101389-10138995.64296.61
599989-9998994.32195.32
699150-9915093.53094.53
二甲双胍恩格列净片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.196099236112916106816112916105136107400.10
210.095921825929865925840.10
单位质量响应值RSD%判断
59935.2358729.831.44数据可信
供试品溶液-2024092321批-二甲双胍-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%
5min1300946-30094645.65453.2818.2345.6553.2818.23
2291597-29159744.23644.24
3342210-34221051.91451.91
4323266-32326649.04049.04
5387680-38768058.81258.81
6461775-46177570.05370.05
10min1544241-54424182.56387.637.4182.6487.727.42
2530068-53006880.41380.49
3567891-56789186.15186.24
4563724-56372485.51985.60
5627182-62718295.14595.24
6632689-63268995.98196.10
15min1648144-64814498.32597.670.9498.5497.900.92
2641693-64169397.34797.55
3644165-64416597.72297.95
4649675-64967598.55898.78
5646115-64611598.01898.27
6632958-63295896.02296.30
20min1650132-65013298.62797.931.4199.0098.331.38
2654361-65436199.26999.64
3643941-64394197.68898.08
4652170-65217098.93699.32
5643350-64335097.59898.02
6629390-62939095.48095.92
30min1648552-64855298.38797.861.3098.9398.421.27
2650869-65086998.73999.27
3644453-64445397.76698.32
4653423-65342399.12699.68
5643421-64342197.60998.19
6629894-62989495.55796.15
45min1651882-65188298.89397.711.3399.6098.441.30
2650210-65021098.63999.34
3643158-64315897.56998.29
4648197-64819798.33399.05
5642803-64280397.51598.26
6628388-62838895.32896.08
60min1647634-64763498.24897.411.3499.1298.301.31
2649396-64939698.51599.38
3642248-64224897.43198.31
4646623-64662398.09598.98
5640847-64084797.21898.13
6625958-62595894.96095.87
极限1645341-64534197.90097.101.1298.9398.151.09
2646509-64650998.07799.11
3639650-63965097.03798.08
4644216-64421697.73098.78
5637359-63735996.68997.76
6627395-62739595.17896.25
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