奥司他韦干糖浆项目信息
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101096-202404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800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562832742833402838192838732831082834830.13
214.372839772838922839340.03
单位质量响应值RSD%判断
19469.9919758.801.05数据可信
长期18月-供试品溶液-2023071521批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1329004-32900495.38393.707.0395.3893.707.03
2314651-31465191.22191.22
3282386-28238681.86781.87
4340939-34093998.84398.84
5327088-32708894.82794.83
6345031-345031100.029100.03
10min1337921-33792197.96896.162.9298.1396.322.92
2325949-32594994.49794.65
3317609-31760992.07992.22
4336747-33674797.62797.79
5327743-32774395.01795.18
6344140-34414099.77199.94
15min1335735-33573597.33495.284.2897.6695.604.28
2320920-32092093.03993.35
3305307-30530788.51388.80
4340960-34096098.84999.18
5327062-32706294.82095.14
6341937-34193799.13299.47
20min1324661-32466194.12494.696.2494.6195.176.23
2313576-31357690.91091.37
3307003-30700389.00489.44
4331027-33102795.96996.46
5318979-31897992.47692.95
6364539-364539105.685106.18
奥司他韦干糖浆项目信息
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101096-202404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800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562833302842352829922833622844152836670.22
214.372843752838022840880.15
单位质量响应值RSD%判断
19482.6219769.521.04数据可信
长期18月-供试品溶液-2023071821批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1324257-32425793.95095.101.7393.9595.111.73
2331314-33131495.99596.00
3336328-33632897.44897.45
4329211-32921195.38695.39
5319940-31994092.70092.70
6328388-32838895.14795.15
10min1322974-32297493.57994.242.1193.7494.402.11
2330104-33010495.64495.80
3334498-33449896.91897.08
4314315-31431591.07091.23
5325223-32522394.23094.38
6324505-32450594.02294.18
15min1318639-31863992.32393.611.9292.6493.921.92
2329091-32909195.35195.67
3331200-33120095.96296.29
4315343-31534391.36891.68
5320020-32002092.72393.03
6324129-32412993.91394.23
20min1321969-32196993.28792.661.4793.7593.131.47
2322680-32268093.49393.97
3326408-32640894.57495.06
4313746-31374690.90591.37
5316784-31678491.78592.25
6317166-31716691.89692.37
奥司他韦干糖浆项目信息
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101096-202404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800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.562947022943132932472947872938762941850.22
214.372855212847772851490.19
单位质量响应值RSD%判断
20205.0119843.351.28数据可信
长期18月-供试品溶液-2023072021批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1319551-31955190.74991.671.6090.7591.671.59
2320020-32002090.88290.88
3324663-32466392.20092.20
4315858-31585889.70089.70
5329010-32901093.43593.43
6327621-32762193.04093.04
10min1334758-33475895.06793.302.2795.2293.462.27
2319139-31913990.63290.78
3323957-32395792.00092.15
4324596-32459692.18192.33
5329687-32968793.62793.78
6339138-33913896.31196.47
15min1328367-32836793.25293.141.2293.5693.451.22
2330335-33033593.81194.11
3324352-32435292.11292.42
4322086-32208691.46991.77
5330000-33000093.71694.03
6332680-33268094.47794.79
20min1335758-33575895.35192.102.2095.8292.572.19
2320336-32033690.97291.43
3321714-32171491.36391.82
4315640-31564089.63890.09
5323392-32339291.83992.31
6329104-32910493.46293.93
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