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%
1 9.855327765327585322835330055323745326390.06
2 9.865318275322435320350.06
单位质量响应值RSD%判断
54075.0353958.920.16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%
5min1456007-45600775.97773.295.3675.9873.295.36
2464112-46411277.32877.33
3436838-43683872.78472.78
4399837-39983766.61966.62
5428844-42884471.45271.45
6453650-45365075.58575.58
10min1569977-56997794.96691.502.7295.0991.622.73
2548417-54841791.37491.50
3551247-55124791.84691.97
4540047-54004789.98090.09
5526746-52674687.76487.88
6558732-55873293.09393.22
15min1593125-59312598.82395.682.1699.1195.962.16
2571047-57104795.14595.43
3574243-57424395.67795.95
4572231-57223195.34295.60
5555183-55518392.50292.77
6579819-57981996.60696.89
20min1597332-59733299.52496.492.0499.9796.922.03
2575758-57575895.93096.37
3574316-57431695.68996.12
4581283-58128396.85097.27
5561890-56189093.61994.04
6584038-58403897.30997.75
30min1599372-59937299.86496.972.04100.4897.572.04
2577851-57785196.27896.88
3576535-57653596.05996.65
4586313-58631397.68898.27
5564519-56451994.05794.63
6587564-58756497.89798.50
45min1600947-600947100.12697.192.10100.9197.952.10
2578998-57899896.46997.23
3578454-57845496.37997.13
4589010-58901098.13898.88
5564904-56490494.12194.85
6587651-58765197.91198.68
60min1601529-601529100.22397.402.05101.1798.322.05
2581431-58143196.87597.80
3579272-57927296.51597.43
4590269-59026998.34799.26
5566104-56610494.32195.21
6588840-58884098.10999.04
极限1629986-629986104.965103.431.70106.08104.511.70
2628416-628416104.703105.79
3630361-630361105.027106.10
4617959-617959102.961104.03
5604892-604892100.784101.83
6613100-613100102.151103.25
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%
1 9.855320005320925321115320015317585319920.03
2 9.865324015322965323480.02
单位质量响应值RSD%判断
54009.3453990.670.03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%
5min1439149-43914973.19174.254.3873.1974.254.39
2455058-45505875.84375.84
3410289-41028968.38168.38
4467139-46713977.85677.86
5452883-45288375.48075.48
6448429-44842974.73874.74
10min1567699-56769994.61694.152.7294.7494.272.72
2547991-54799191.33291.46
3545505-54550590.91791.03
4578820-57882096.47096.60
5582553-58255397.09297.22
6566784-56678494.46494.59
15min1594259-59425999.04398.472.6999.3298.752.69
2567965-56796594.66194.94
3576153-57615396.02596.29
4599817-59981799.969100.26
5610959-610959101.826102.11
6595787-59578799.29899.58
20min1601695-601695100.282100.322.56100.73100.772.56
2579645-57964596.60797.04
3590552-59055298.42598.85
4609088-609088101.515101.97
5623771-623771103.962104.42
6606872-606872101.145101.59
30min1604527-604527100.754101.441.99101.37102.061.99
2591891-59189198.64899.25
3599627-59962799.938100.53
4616980-616980102.830103.46
5624327-624327104.054104.69
6614598-614598102.433103.05
45min1605998-605998101.000102.341.56101.78103.121.56
2599236-59923699.873100.63
3617049-617049102.841103.60
4619610-619610103.268104.07
5624863-624863104.144104.95
6617533-617533102.922103.71
60min1605948-605948100.991102.031.58101.94102.981.58
2600896-600896100.149101.08
3604036-604036100.673101.60
4619985-619985103.331104.30
5623450-623450103.908104.89
6618794-618794103.132104.09
极限1606379-606379101.063102.881.23102.18104.011.24
2615278-615278102.546103.64
3611225-611225101.871102.97
4621654-621654103.609104.75
5624806-624806104.134105.29
6624464-624464104.077105.21
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%
1 9.855354895349665352395350035347625350920.06
2 9.865324865327535326200.04
单位质量响应值RSD%判断
54324.0654018.260.40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%
5min1436575-43657572.53371.045.4272.5371.045.42
2454596-45459675.52775.53
3450196-45019674.79674.80
4420005-42000569.78069.78
5401448-40144866.69766.70
6402758-40275866.91566.91
10min1560196-56019693.07293.591.7593.1993.701.75
2555796-55579692.34192.47
3561321-56132193.25993.38
4574792-57479295.49795.61
5551935-55193591.69991.81
6575726-57572695.65295.76
15min1590355-59035598.08298.551.9098.3698.821.89
2579382-57938296.25996.54
3589679-58967997.97098.25
4606459-606459100.758101.03
5585929-58592997.34797.61
6607060-607060100.858101.13
20min1600733-60073399.807100.261.69100.25100.701.69
2587893-58789397.67398.11
3602940-602940100.173100.62
4613706-613706101.962102.41
5599681-59968199.632100.06
6615717-615717102.296102.74
30min1612077-612077101.691101.441.61102.30102.041.60
2593257-59325798.56599.17
3609422-609422101.250101.86
4617979-617979102.672103.29
5609065-609065101.191101.78
6621407-621407103.241103.85
45min1619299-619299102.891102.591.02103.67103.361.02
2606108-606108100.700101.47
3617903-617903102.659103.44
4620140-620140103.031103.82
5616378-616378102.406103.17
6624999-624999103.838104.62
60min1621927-621927103.328102.881.21104.27103.831.20
2604742-604742100.473101.41
3620626-620626103.112104.06
4620029-620029103.012103.97
5621607-621607103.275104.21
6626561-626561104.098105.05
极限1638615-638615106.100106.250.94107.22107.360.93
2637961-637961105.992107.09
3636904-636904105.816106.94
4632315-632315105.054106.18
5650261-650261108.035109.14
6640981-640981106.493107.62
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