奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
113.592684462684272683972681912680102682940.08
213.672697812693692695750.11
单位质量响应值RSD%判断
19742.0219720.190.08数据可信
长期12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%
5min1319114-31911492.05690.653.6892.0690.653.69
2331526-33152695.63695.64
3316233-31623391.22491.22
4297470-29747085.81285.81
5314607-31460790.75590.76
6306465-30646588.40788.41
10min1331458-33145895.61693.472.5696.1393.982.56
2327499-32749994.47495.01
3319572-31957292.18892.69
4316111-31611191.18991.67
5334546-33454696.50797.01
6314978-31497890.86291.35
15min1330750-33075095.41294.262.6996.4595.282.69
2331040-33104095.49696.55
3330379-33037995.30596.32
4315423-31542390.99191.97
5336714-33671497.13398.17
6316244-31624491.22892.22
20min1331324-33132495.57894.593.5397.1596.143.51
2328942-32894294.89196.48
3325462-32546293.88795.44
4317029-31702991.45492.94
5348020-348020100.394101.97
6316631-31663191.33992.84
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
113.592696452695762696632691082690172694020.12
213.672714322713832714080.02
单位质量响应值RSD%判断
19823.5519854.280.11数据可信
长期12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%
5min1319893-31989391.77990.484.2291.7890.484.22
2312254-31225489.58789.59
3328526-32852694.25694.26
4308262-30826288.44288.44
5329014-32901494.39694.40
6294325-29432584.44384.44
10min1328072-32807294.12593.871.9094.6494.371.91
2331286-33128695.04795.55
3332516-33251695.40095.92
4318394-31839491.34991.84
5332221-33222195.31695.84
6320540-32054091.96492.43
15min1321259-32125992.17193.892.1393.2094.912.13
2331156-33115695.01096.04
3335509-33550996.25997.31
4318391-31839191.34892.35
5333067-33306795.55896.61
6324034-32403492.96793.95
20min1325120-32512093.27893.242.0994.8294.792.09
2331842-33184295.20796.76
3329076-32907694.41396.00
4314330-31433090.18391.69
5329984-32998494.67496.26
6319666-31966691.71493.21
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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%
113.592671112671442671862673882673402672340.05
213.672687572683292685430.12
单位质量响应值RSD%判断
19664.0219644.700.07数据可信
长期12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%
5min1315413-31541391.34391.072.7791.3491.072.77
2299126-29912686.62686.63
3311276-31127690.14590.15
4324651-32465194.01894.02
5318979-31897992.37692.38
6317376-31737691.91291.91
10min1326066-32606694.42896.453.1294.9496.963.11
2320058-32005892.68893.17
3338806-33880698.11898.62
4332867-33286796.39896.92
5330667-33066795.76196.27
6349783-349783101.297101.81
15min1336397-33639797.42097.862.6698.4598.902.65
2335478-33547897.15498.15
3342210-34221099.104100.15
4326906-32690694.67295.73
5333354-33335496.53997.58
6353250-353250102.301103.37
20min1338689-33868998.08497.663.2799.6699.243.24
2340272-34027298.542100.08
3340088-34008898.489100.09
4326835-32683594.65196.23
5323274-32327493.62095.20
6354090-354090102.544104.19
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