盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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%
110.882271372273542275082273622273052273330.06
2 10.952275082274372274720.03
单位质量响应值RSD%判断
20894.5820773.700.42数据可信
供试品溶液-YD2批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1227452-22745298.06097.750.7298.0697.750.72
2225133-22513397.06097.06
3226909-22690997.82697.83
4229385-22938598.89398.89
5226510-22651097.65497.65
6224981-22498196.99496.99
10min1236347-236347101.895100.750.71102.06100.910.71
2233076-233076100.484100.65
3232925-232925100.419100.58
4235045-235045101.333101.50
5232114-232114100.070100.23
6232647-232647100.299100.46
15min1238356-238356102.761101.950.67103.09102.280.67
2237512-237512102.397102.73
3235382-235382101.479101.81
4237572-237572102.423102.76
5234264-234264100.997101.33
6235746-235746101.636101.96
20min1239304-239304103.169102.280.61103.67102.780.60
2237532-237532102.406102.91
3236327-236327101.886102.39
4238277-238277102.727103.23
5235357-235357101.468101.97
6236634-236634102.018102.52
30min1240806-240806103.817103.250.30104.49103.920.30
2239370-239370103.198103.87
3238728-238728102.921103.59
4239540-239540103.271103.95
5239294-239294103.165103.83
6239171-239171103.112103.78
极限1244942-244942105.600104.240.75106.45105.080.75
2240802-240802103.815104.66
3241227-241227103.999104.84
4242918-242918104.728105.58
5240377-240377103.632104.47
6240452-240452103.664104.50
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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%
110.882272532274082276392274432275322274550.07
2 10.952275162278162276660.10
单位质量响应值RSD%判断
20905.7920791.420.39数据可信
供试品溶液-25020801批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1224112-22411296.55395.451.1396.5595.441.13
2221186-22118695.29295.29
3224611-22461196.76896.77
4220869-22086995.15695.16
5220629-22062995.05295.05
6217848-21784893.85493.85
10min1231286-23128699.64398.671.0899.8098.831.08
2228249-22824998.33598.49
3232337-232337100.096100.26
4229375-22937598.82098.98
5226929-22692997.76697.92
6226001-22600197.36797.52
15min1234729-234729101.12799.861.29101.45100.191.28
2231451-23145199.715100.04
3236117-236117101.725102.05
4230221-23022199.18599.51
5228944-22894498.63498.96
6229302-22930298.78999.11
20min1235785-235785101.582100.951.12102.08101.441.12
2232918-232918100.347100.84
3238469-238469102.738103.24
4233534-233534100.612101.10
5234325-234325100.953101.44
6230829-23082999.44799.93
30min1238077-238077102.569101.641.49103.23102.301.48
2235014-235014101.250101.91
3242007-242007104.262104.93
4233040-233040100.399101.06
5233273-233273100.499101.15
6234133-234133100.870101.52
极限1239411-239411103.144102.701.04103.98103.531.04
2239000-239000102.967103.79
3242088-242088104.297105.14
4238619-238619102.803103.63
5235897-235897101.630102.45
6235337-235337101.389102.21
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