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%
112.382001531993762007062002771993711999770.30
212.422018612020632019620.08
单位质量响应值RSD%判断
16153.2316261.030.48数据可信
供试品溶液-24102201批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1130477-13047764.91966.931.7364.9266.941.73
2137203-13720368.26668.27
3134070-13407066.70766.71
4136261-13626167.79767.80
5134270-13427066.80766.81
6134855-13485567.09867.10
10min1149146-14914674.20874.831.7474.3174.931.73
2154218-15421876.73276.83
3149471-14947174.37074.47
4153082-15308276.16776.27
5148654-14865473.96374.06
6147827-14782773.55273.65
15min1151093-15109375.17776.041.6575.3976.261.65
2156650-15665077.94278.16
3151690-15169075.47475.69
4155318-15531877.27977.50
5151771-15177175.51475.73
6150473-15047374.86975.08
20min1152417-15241775.83676.781.6076.1677.101.60
2157886-15788678.55778.89
3153729-15372976.48976.81
4156882-15688278.05778.39
5152846-15284676.04976.37
6152084-15208475.67075.99
30min1154102-15410276.67477.751.7277.1178.191.72
2160427-16042779.82180.27
3156044-15604477.64078.08
4158417-15841778.82179.27
5155207-15520777.22477.66
6153426-15342676.33876.77
45min1157734-15773478.48179.231.3379.0379.781.33
2162561-16256180.88381.45
3158818-15881879.02179.58
4160672-16067279.94380.51
5158919-15891979.07179.63
6156675-15667577.95478.51
60min1158597-15859778.91180.401.7779.5881.081.77
2166259-16625982.72383.42
3161245-16124580.22880.90
4162940-16294081.07281.76
5161682-16168280.44681.12
6158776-15877679.00079.67
极限1191355-19135595.21095.181.1196.0095.981.11
2194711-19471196.87997.70
3191761-19176195.41296.21
4189308-18930894.19195.00
5191847-19184795.45496.25
6188833-18883393.95594.74
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