塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.661433852143389914334581432504143358814334600.04
29.601433378143414414337610.04
单位质量响应值RSD%判断
148391.30149350.100.46数据可信
中间条件18月-供试品溶液-2023010711批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1273062-27306218.26917.418.5218.2717.418.52
2246514-24651416.49316.49
3241624-24162416.16616.17
4265174-26517417.74117.74
5238906-23890615.98415.98
6295990-29599019.80319.80
10min1586793-58679339.25939.416.8239.3039.456.82
2567951-56795137.99838.03
3559646-55964637.44337.48
4608406-60840640.70540.74
5552032-55203236.93336.97
6659815-65981544.14544.18
15min1867801-86780158.06058.085.6558.1758.195.65
2837041-83704156.00256.11
3836892-83689255.99256.10
4887656-88765659.38859.50
5823461-82346155.09355.20
6955725-95572563.94264.07
20min11088797-108879772.84573.094.8573.0873.324.85
21067746-106774671.43771.66
31057147-105714770.72870.95
41104515-110451573.89774.13
51044953-104495369.91270.13
61191206-119120679.69779.95
30min11373024-137302491.86192.522.7992.2492.892.80
21361438-136143891.08691.45
31358035-135803590.85891.22
41395373-139537393.35793.74
51353955-135395590.58690.94
61455200-145520097.35997.77
45min11479375-147937598.97799.510.7999.54100.070.80
21482422-148242299.18199.73
31473552-147355298.58799.13
41505646-1505646100.734101.30
51487193-148719399.500100.04
61496003-1496003100.089100.70
60min11486380-148638099.44599.700.71100.20100.460.72
21482089-148208999.15899.90
31479414-147941498.97999.72
41508559-1508559100.929101.70
51489756-148975699.671100.41
61494890-1494890100.015100.82
极限11485962-148596299.41799.860.80100.37100.820.81
21483156-148315699.230100.17
31489142-148914299.630100.57
41516120-1516120101.435102.41
51489289-148928999.640100.58
61491480-149148099.787100.80
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100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%
19.661435049143384514341281438038143447414351070.12
29.601433430143365214335410.02
单位质量响应值RSD%判断
148561.80149327.190.37数据可信
中间条件18月-供试品溶液-2023010711批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1234280-23428015.66719.4614.5815.6719.4614.58
2265881-26588117.78017.78
3321250-32125021.48221.48
4353523-35352323.64023.64
5274031-27403118.32518.32
6296725-29672519.84219.84
10min1553292-55329236.99942.8410.9837.0342.8810.99
2608280-60828040.67640.71
3688661-68866146.05146.09
4743800-74380049.73949.79
5588708-58870839.36739.40
6660952-66095244.19944.24
15min1837229-83722955.98662.418.9556.0962.548.96
2887496-88749659.34859.46
3980603-98060365.57465.71
41063985-106398571.15071.30
5872950-87295058.37558.49
6957573-95757364.03464.16
20min11060066-106006670.88877.477.8171.1077.727.82
21106128-110612873.96874.20
31201386-120138680.33880.60
41302826-130282687.12187.41
51089827-108982772.87873.11
61190956-119095679.64079.90
30min11359979-135997990.94394.893.3291.3095.293.34
21397508-139750893.45393.84
31451085-145108597.03597.46
41471532-147153298.40398.87
51376090-137609092.02192.40
61457469-145746997.46297.88
45min11466020-146602098.03499.320.9798.5899.920.97
21504660-1504660100.618101.19
31491213-149121399.719100.34
41474411-147441198.59599.26
51479935-147993598.96599.53
61495428-1495428100.001100.61
60min11471624-147162498.40999.520.9999.15100.320.98
21508977-1508977100.907101.68
31492476-149247699.803100.62
41472701-147270198.48199.34
51486020-148602099.372100.13
61497921-1497921100.167100.98
极限11474088-147408898.57499.871.1599.51100.861.15
21518226-1518226101.525102.50
31503797-1503797100.560101.58
41475833-147583398.69099.74
51489008-148900899.571100.53
61500160-1500160100.317101.33
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