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%
19.855280155287225282455285825283585283840.06
29.865270805280345275570.13
单位质量响应值RSD%判断
53643.0553504.770.19数据可信
加速6月-供试品溶液-2024052811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%
5min1461579-46157977.54272.888.4977.5472.888.49
2486817-48681781.78281.78
3442168-44216874.28174.28
4406266-40626668.25068.25
5387667-38766765.12565.13
6418365-41836570.28270.28
10min1542375-54237591.11590.533.5891.2490.653.59
2569656-56965695.69895.83
3545258-54525891.59991.72
4533318-53331889.59389.71
5531684-53168489.31989.43
6511011-51101185.84685.96
15min1561233-56123394.28394.752.3594.5695.022.35
2588305-58830598.83199.13
3563764-56376494.70894.98
4561253-56125394.28694.55
5561632-56163294.35094.61
6547869-54786992.03892.30
20min1564640-56464094.85597.103.6395.2997.533.61
2594041-59404199.794100.25
3567390-56739095.31795.75
4570876-57087695.90396.32
5612777-612777102.942103.36
6558435-55843593.81394.23
30min1566967-56696795.24697.232.6295.8497.822.61
2596346-596346100.182100.81
3571216-57121695.96096.55
4574506-57450696.51397.09
5599069-599069100.639101.23
6564377-56437794.81195.38
45min1569195-56919595.62096.881.7896.3897.641.79
2595501-595501100.040100.83
3573680-57368096.37497.13
4575764-57576496.72497.46
5579378-57937897.33198.09
6566803-56680395.21995.95
60min1568895-56889595.57097.202.1896.4898.122.18
2602416-602416101.201102.16
3574490-57449096.51097.42
4576117-57611796.78397.69
5580980-58098097.60098.52
6568679-56867995.53496.42
极限1605350-605350101.694102.501.81102.77103.581.81
2626433-626433105.236106.37
3604678-604678101.581102.66
4601551-601551101.056102.12
5621696-621696104.440105.52
6601177-601177100.993102.04
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%
19.855286475291035289885287375291475289240.05
29.865274515280145277320.08
单位质量响应值RSD%判断
53697.8753522.520.24数据可信
加速6月-供试品溶液-2024052911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%
5min1463553-46355377.82173.903.6177.8273.903.61
2456648-45664876.66276.66
3433552-43355272.78472.78
4433487-43348772.77372.77
5425247-42524771.39071.39
6428762-42876271.98071.98
10min1564764-56476494.81292.352.1494.9492.482.14
2549667-54966792.27892.41
3529125-52912588.82988.95
4555341-55534193.23093.35
5549064-54906492.17692.30
6552694-55269492.78692.91
15min1600481-600481100.80897.673.10101.1097.953.10
2568716-56871695.47595.76
3553537-55353792.92793.20
4586530-58653098.46698.74
5598639-598639100.499100.77
6582790-58279097.83898.11
20min1597470-597470100.30398.982.16100.7699.422.16
2581333-58133397.59498.03
3567573-56757395.28495.71
4598117-598117100.411100.85
5599988-599988100.725101.17
6592932-59293299.54199.98
30min1616351-616351103.472101.121.77104.10101.721.77
2597319-597319100.277100.88
3586536-58653698.46799.05
4604205-604205101.433102.04
5611115-611115102.593103.20
6598497-598497100.475101.08
45min1609347-609347102.297101.781.29103.09102.561.29
2610729-610729102.529103.30
3592294-59229499.434100.18
4608219-608219102.107102.88
5614267-614267103.123103.90
6602853-602853101.206101.98
60min1611308-611308102.626102.171.18103.59103.121.18
2614883-614883103.226104.17
3596390-596390100.121101.03
4609446-609446102.313103.26
5615024-615024103.250104.20
6604638-604638101.506102.45
极限1620790-620790104.218104.542.42105.35105.662.40
2619124-619124103.938105.05
3617256-617256103.624104.70
4619170-619170103.946105.06
5651980-651980109.454110.58
6608081-608081102.084103.19
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%
19.855280405284025289425279475283915283440.08
29.865279795282055280920.04
单位质量响应值RSD%判断
53638.9853559.030.11数据可信
加速6月-供试品溶液-2024053011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%
5min1413101-41310169.36570.255.8369.3770.255.83
2439460-43946073.79173.79
3451821-45182175.86775.87
4414095-41409569.53269.53
5382666-38266664.25564.25
6409200-40920068.71068.71
10min1544455-54445591.42192.111.3391.5492.231.33
2549665-54966592.29692.42
3560704-56070494.15094.28
4548087-54808792.03192.15
5549734-54973492.30892.41
6538679-53867990.45290.57
15min1572299-57229996.09797.131.1196.3697.401.11
2577018-57701896.88997.17
3584935-58493598.21998.50
4579316-57931697.27597.54
5586389-58638998.46398.72
6570690-57069095.82796.09
20min1583881-58388198.04299.001.0498.4799.431.04
2591308-59130899.28999.73
3596192-596192100.109100.56
4589489-58948998.98399.41
5595537-59553799.999100.42
6581187-58118797.58998.01
30min1594958-59495899.902100.321.09100.49100.921.09
2601021-601021100.920101.52
3602322-602322101.138101.75
4599631-599631100.686101.28
5601391-601391100.982101.57
6585398-58539898.29698.88
45min1626125-626125105.135101.711.99105.89102.471.98
2606937-606937101.913102.68
3604671-604671101.533102.31
4602091-602091101.099101.86
5605732-605732101.711102.47
6588640-58864098.84199.59
60min1602846-602846101.226101.410.42102.16102.340.42
2605954-605954101.748102.69
3605055-605055101.597102.55
4602368-602368101.146102.08
5607009-607009101.925102.85
6600252-600252100.791101.71
极限1639428-639428107.369104.941.65108.47106.041.64
2627916-627916105.436106.55
3626853-626853105.257106.38
4623420-623420104.681105.78
5624697-624697104.895105.99
6607550-607550102.016103.10
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