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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.109729997001970439722697550972240.23
210.149678397087969350.23
单位质量响应值RSD%判断
9626.149559.660.50数据可信
供试品溶液-2024112921批-恩格列净-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%
5min139498-3949837.05735.167.1037.0635.167.10
234455-3445532.32632.33
334760-3476032.61232.61
441204-4120438.65838.66
538111-3811135.75635.76
636804-3680434.53034.53
10min177680-7768072.88070.565.1672.9470.625.17
271944-7194467.49867.55
371251-7125166.84866.90
481643-8164376.59876.66
574473-7447369.87169.93
674263-7426369.67469.73
15min199882-9988293.71090.392.4493.8990.562.44
294976-9497689.10789.27
392848-9284887.11087.28
497231-9723191.22391.41
596390-9639090.43490.61
696703-9670390.72790.90
20min1100986-10098694.74693.991.1595.0894.311.14
2101559-10155995.28395.60
399157-9915793.03093.34
498539-9853992.45092.79
5100127-10012793.94094.27
6100695-10069594.47394.80
30min1100541-10054194.32894.711.6494.8395.191.62
2103505-10350597.10997.58
3100737-10073794.51294.98
498639-9863992.54493.04
5100266-10026694.07094.55
6101977-10197795.67596.16
45min1100679-10067994.45894.831.9295.1195.471.90
2103792-10379297.37898.01
3101209-10120994.95595.58
498145-9814592.08092.73
5100217-10021794.02494.66
6102432-10243296.10296.74
60min1103443-10344397.05195.422.2497.8696.222.23
2104115-10411597.68198.48
3101292-10129295.03395.81
498288-9828892.21493.02
599940-9994093.76494.56
6103166-10316696.79197.59
极限1100478-10047894.26995.032.1795.2495.992.15
2104095-10409597.66298.62
3101940-10194095.64196.58
497928-9792891.87792.84
5100325-10032594.12595.08
6102986-10298696.62297.59
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10
标示量(mg)1000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%
110.101010553100890010075631010781101143610098470.16
210.039845109830169837630.11
单位质量响应值RSD%判断
99984.8598082.051.36数据可信
供试品溶液-2024112921批-二甲双胍-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%
5min1477045-47704543.35741.186.4143.3641.186.41
2417523-41752337.94737.95
3424052-42405238.54138.54
4490740-49074044.60244.60
5461959-46195941.98641.99
6447398-44739840.66340.66
10min1853314-85331477.55575.094.9277.6375.164.92
2789624-78962471.76671.83
3782216-78221671.09371.16
4890476-89047680.93281.01
5825866-82586675.06075.13
6815500-81550074.11874.19
15min11053000-105300095.70492.442.5395.9192.642.53
2998769-99876990.77590.96
3978171-97817188.90389.09
41024976-102497693.15793.37
51024103-102410393.07793.27
61023720-102372093.04393.23
20min11060444-106044496.38095.551.2496.7495.901.23
21061300-106130096.45896.79
31036038-103603894.16294.49
41033662-103366293.94694.31
51055855-105585595.96396.31
61060743-106074396.40896.75
30min11059037-105903796.25296.051.3596.7796.561.34
21074852-107485297.69098.18
31052531-105253195.66196.15
41032740-103274093.86294.38
51055756-105575695.95496.46
61066075-106607596.89297.40
45min11054113-105411395.80596.101.6296.4996.761.60
21078707-107870798.04098.70
31055882-105588295.96696.61
41029859-102985993.60194.28
51053534-105353495.75296.42
61071848-107184897.41798.09
60min11082502-108250298.38596.592.0499.2397.422.02
21080849-108084998.23599.06
31058101-105810196.16796.97
41026784-102678493.32194.15
51051956-105195695.60996.44
61076439-107643997.83498.66
极限11051673-105167395.58395.831.7096.5996.821.68
21076034-107603497.79798.78
31056588-105658896.03097.00
41024204-102420493.08794.08
51050237-105023795.45396.44
61067876-106787697.05698.05
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