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%
1 12.311991171989931979851997391989961989660.32
2 12.271987752002301995020.52
单位质量响应值RSD%判断
16162.9616259.330.43数据可信
供试品溶液-WK2927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%
5min1159927-15992779.31761.7418.0979.3261.7418.09
293331-9333146.28846.29
3118468-11846858.75558.76
4138291-13829168.58768.59
5120384-12038459.70659.71
6116499-11649957.77957.78
10min1192457-19245795.45193.831.0195.5793.931.02
2187723-18772393.10393.17
3189571-18957194.02094.11
4187063-18706392.77692.88
5188735-18873593.60593.69
6189640-18964094.05494.14
15min1193850-19385096.14296.370.9396.4096.600.93
2193636-19363696.03696.24
3193362-19336295.90096.13
4192190-19219095.31895.56
5195550-19555096.98597.21
6197252-19725297.82998.06
20min1193876-19387696.15596.371.3196.5696.751.30
2194382-19438296.40696.76
3194790-19479096.60896.98
4189747-18974794.10794.49
5195886-19588697.15297.53
6197196-19719697.80198.18
30min1192374-19237495.41096.261.4295.9696.781.40
2194526-19452696.47796.97
3194856-19485696.64197.16
4189563-18956394.01694.54
5196088-19608897.25297.77
6197133-19713397.77098.29
45min1192988-19298895.71496.431.5096.4197.101.48
2196065-19606597.24097.88
3194424-19442496.42697.09
4189389-18938993.92994.60
5196633-19663397.52298.19
6197083-19708397.74598.41
60min1192875-19287595.65896.141.4096.5096.951.38
2195802-19580297.11097.90
3193056-19305695.74896.56
4189278-18927893.87494.68
5196563-19656397.48798.30
6195506-19550696.96397.78
极限1192936-19293695.68896.091.4796.6797.041.46
2195566-19556696.99397.93
3193082-19308295.76196.71
4188756-18875693.61594.56
5196520-19652097.46698.43
6195587-19558797.00397.96
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%
1 12.311981451992551976481978611992241984270.39
2 12.271982911994361988640.41
单位质量响应值RSD%判断
16119.1716207.330.39数据可信
供试品溶液-WK2927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%
5min1156622-15662277.90865.2718.1177.9165.2818.11
2137428-13742868.36168.36
3135312-13531267.30867.31
4109326-10932654.38254.38
5152147-15214775.68275.68
696509-9650948.00648.01
10min1198547-19854798.76395.041.9898.8895.141.99
2190392-19039294.70694.81
3188411-18841193.72193.82
4190698-19069894.85994.94
5188673-18867393.85193.96
6189625-18962594.32594.40
15min1200058-20005899.51597.681.1299.7897.921.12
2195944-19594497.46897.71
3195334-19533497.16597.41
4197735-19773598.35998.58
5193998-19399896.50096.75
6195128-19512897.06297.28
20min1200216-20021699.59397.941.25100.0198.331.25
2196159-19615997.57597.97
3195482-19548297.23897.63
4199695-19969599.33499.71
5194451-19445196.72597.12
6195330-19533097.16397.52
30min1201601-201601100.28297.941.53100.8598.481.53
2196195-19619597.59398.13
3195767-19576797.38097.91
4199418-19941899.19699.72
5193779-19377996.39196.94
6194638-19463896.81897.32
45min1203608-203608101.28098.031.86101.9998.711.86
2196284-19628497.63798.32
3194323-19432396.66297.34
4199029-19902999.00399.67
5194364-19436496.68297.37
6194808-19480896.90397.55
60min1201978-201978100.47097.761.67101.3498.581.67
2195678-19567897.33698.17
3194459-19445996.72997.55
4198985-19898598.98199.80
5194260-19426096.63097.46
6193780-19378096.39297.19
极限1201324-201324100.14497.601.55101.1698.581.55
2196294-19629497.64298.62
3193590-19359096.29797.27
4197973-19797398.47799.44
5194291-19429196.64697.62
6193787-19378796.39597.34
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