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对照品来源中检所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%
19.855316475315415285825314035314225309190.25
29.865323255319495321370.05
单位质量响应值RSD%判断
53900.4153969.270.10数据可信
加速6月-供试品溶液-F56971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%
5min1413807-41380769.05167.692.3369.0567.692.33
2417523-41752369.67169.67
3406954-40695467.90867.91
4400463-40046366.82466.82
5391388-39138865.31065.31
6403773-40377367.37767.38
10min1534291-53429189.15687.571.1989.2787.691.18
2516108-51610886.12286.24
3524884-52488487.58687.70
4528158-52815888.13388.24
5520889-52088986.92087.03
6524544-52454487.53087.64
15min1555122-55512292.63291.421.4392.9091.681.43
2534773-53477389.23789.50
3544062-54406290.78791.05
4553768-55376892.40692.66
5546158-54615891.13691.39
6553266-55326692.32292.58
20min1560246-56024693.48792.701.8793.9193.111.87
2540816-54081690.24590.65
3548257-54825791.48791.90
4560567-56056793.54193.95
5553129-55312992.30092.71
6570173-57017395.14495.56
30min1564307-56430794.16593.680.5694.7494.250.56
2562134-56213493.80294.36
3562826-56282693.91894.48
4564044-56404494.12194.69
5558318-55831893.16593.72
6556861-55686192.92293.49
45min1567365-56736594.67593.391.3995.4194.111.39
2547078-54707891.29092.00
3554972-55497292.60793.33
4567310-56731094.66695.39
5560944-56094493.60494.32
6560177-56017793.47694.20
60min1569304-56930494.99994.301.8095.8995.181.78
2549285-54928591.65892.53
3579364-57936496.67797.55
4569195-56919594.98095.86
5563414-56341494.01694.89
6560318-56031893.49994.38
极限1617912-617912103.110102.021.00104.16103.050.99
2606084-606084101.136102.16
3604286-604286100.836101.87
4615779-615779102.754103.79
5616652-616652102.900103.93
6607435-607435101.362102.40
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对照品来源中检所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%
19.855323025324495327735327715326015325790.04
29.865309735306195307960.05
单位质量响应值RSD%判断
54068.9353833.270.31数据可信
加速6月-供试品溶液-F56971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%
5min1291977-29197748.70763.0913.5848.7163.1013.58
2402229-40222967.09967.10
3338545-33854556.47656.48
4402962-40296267.22267.22
5417277-41727769.61069.61
6416312-41631269.44969.45
10min1514828-51482885.88387.514.2385.9687.614.24
2531278-53127888.62788.74
3484645-48464580.84880.94
4530614-53061488.51688.63
5542823-54282390.55390.67
6543225-54322590.62090.74
15min1539764-53976490.04391.632.9390.2791.892.94
2552653-55265392.19392.45
3522920-52292087.23387.46
4550815-55081591.88692.15
5563475-56347593.99894.27
6566200-56620094.45394.72
20min1550478-55047891.83092.772.3892.2093.172.40
2558900-55890093.23593.65
3533753-53375389.04089.41
4555984-55598492.74893.16
5565777-56577794.38294.81
6571692-57169295.36995.79
30min1554899-55489992.56793.532.1093.0994.092.12
2562812-56281293.88794.46
3541340-54134090.30690.83
4560764-56076493.54694.11
5568978-56897894.91695.50
6575212-57521295.95696.54
45min1559554-55955493.34494.081.8094.0394.801.81
2565796-56579694.38595.11
3547836-54783691.38992.06
4562838-56283893.89294.62
5570045-57004595.09495.83
6577775-57777596.38497.13
60min1564973-56497394.24894.591.5295.0995.461.53
2567885-56788594.73495.62
3553340-55334092.30793.13
4565182-56518294.28395.16
5571524-57152495.34196.24
6579336-57933696.64497.55
极限1609252-609252101.635101.871.17102.63102.901.14
2604692-604692100.874101.91
3619416-619416103.330104.31
4619799-619799103.394104.43
5605820-605820101.062102.12
6604901-604901100.909101.97
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