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%
113.592708572704762703632703682710532706230.12
213.672714512713342713920.04
单位质量响应值RSD%判断
19913.3919853.110.22数据可信
供试品溶液-B24060751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%
5min1319455-31945591.44993.192.3091.4593.192.30
2321662-32166292.08192.08
3321105-32110591.92191.92
4321146-32114691.93391.93
5337439-33743996.59796.60
6332380-33238095.14995.15
10min1332959-33295995.31595.991.1995.8296.511.19
2331823-33182394.98995.50
3330518-33051894.61695.13
4339306-33930697.13297.64
5338354-33835496.85997.40
6338951-33895197.03097.56
15min1351174-351174100.52997.662.56101.5798.712.52
2347897-34789799.591100.63
3347234-34723499.401100.44
4329800-32980094.41095.46
5334321-33432195.70596.78
6336475-33647596.32197.39
20min1352790-352790100.99295.713.21102.5997.303.16
2340670-34067097.52299.11
3325588-32558893.20594.79
4325462-32546293.16894.74
5333052-33305295.34196.95
6328408-32840894.01295.61
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%
113.592712182712642712552710852716492712940.08
213.672722452720392721420.06
单位质量响应值RSD%判断
19962.7719907.970.20数据可信
供试品溶液-B24060751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%
5min1319760-31976091.29793.351.8191.3093.351.81
2330017-33001794.22594.23
3325295-32529592.87792.88
4326054-32605493.09493.09
5323684-32368492.41792.42
6336879-33687996.18596.18
10min1330629-33062994.40095.840.9094.9196.360.90
2337659-33765996.40796.93
3336034-33603495.94396.46
4339518-33951896.93897.46
5335281-33528195.72896.24
6334840-33484095.60296.14
15min1340715-34071597.28095.841.9898.3196.901.95
2330988-33098894.50395.56
3337120-33712096.25397.30
4329718-32971894.14095.20
5345721-34572198.70999.75
6329876-32987694.18595.25
20min1343361-34336198.03594.891.8899.6196.481.84
2330764-33076494.43996.02
3328212-32821293.71095.29
4332159-33215994.83796.42
5334299-33429995.44897.04
6325328-32532892.88794.48
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%
113.592686162683742686122686612683872685300.06
213.672680552679742680140.03
单位质量响应值RSD%判断
19759.3819606.000.56数据可信
供试品溶液-B24060951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%
5min1345203-34520399.82897.292.4099.8397.292.40
2339681-33968198.23198.23
3324186-32418693.75093.75
4341148-34114898.65598.66
5328924-32892495.12095.12
6339387-33938798.14698.15
10min1352580-352580101.961101.140.54102.52101.680.54
2349799-349799101.157101.70
3347946-347946100.621101.14
4348705-348705100.841101.39
5351274-351274101.584102.11
6348145-348145100.679101.22
15min1370053-370053107.014102.202.52108.14103.302.51
2353570-353570102.248103.36
3352641-352641101.979103.06
4352128-352128101.831102.94
5348022-348022100.643101.74
6344020-34402099.486100.59
20min1352280-352280101.874100.772.00103.59102.441.98
2360594-360594104.279105.95
3344652-34465299.669101.31
4344780-34478099.706101.38
5346928-346928100.327101.98
6341465-34146598.747100.40
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%
113.592681932677032679452678732679222679270.07
213.672686202680272683240.16
单位质量响应值RSD%判断
19715.0119628.680.32数据可信
供试品溶液-B24060951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%
5min1336050-33605097.23497.151.5197.2397.161.51
2332358-33235896.16596.17
3335075-33507596.95196.95
4342662-34266299.14799.15
5339909-33990998.35098.35
6328604-32860495.07995.08
10min1349869-349869101.232101.501.02101.77102.031.01
2350664-350664101.462102.00
3348393-348393100.805101.34
4349106-349106101.011101.56
5357836-357836103.537104.08
6348807-348807100.925101.45
15min1351506-351506101.706101.931.96102.81103.031.94
2353055-353055102.154103.25
3364805-364805105.554106.65
4351367-351367101.665102.78
5348783-348783100.918102.04
6344085-34408599.558100.65
20min1348466-348466100.826100.440.47102.49102.120.47
2346103-346103100.142101.81
3345939-345939100.095101.78
4346934-346934100.383102.06
5349700-349700101.183102.87
6345728-345728100.034101.68
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%
113.592721772719982720872717862718812719860.06
213.672736112735252735680.03
单位质量响应值RSD%判断
20013.6920012.290.01数据可信
供试品溶液-B24061151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%
5min1322074-32207491.60192.831.8691.6092.831.86
2336977-33697795.83995.84
3327974-32797493.27993.28
4321499-32149991.43791.44
5328311-32831193.37593.37
6321597-32159791.46591.47
10min1346169-34616998.454100.242.1698.96100.762.15
2353330-353330100.490101.02
3345148-34514898.16398.68
4349651-34965199.44499.95
5354433-354433100.804101.32
6366034-366034104.103104.61
15min1352068-352068100.131100.922.31101.19102.002.30
2354359-354359100.783101.87
3345013-34501398.12599.19
4350287-35028799.625100.69
5358554-358554101.976103.05
6368853-368853104.905105.99
20min1352221-352221100.175100.141.16101.79101.771.16
2349927-34992799.522101.17
3345883-34588398.37299.98
4351617-351617100.003101.62
5355837-355837101.203102.85
6357061-357061101.551103.22
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%
113.592716442715952713062717992711162714920.11
213.672709452703002706220.17
单位质量响应值RSD%判断
19977.3419796.780.65数据可信
供试品溶液-B24061151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%
5min1320228-32022891.65493.221.4191.6593.221.41
2332684-33268495.21995.22
3324172-32417292.78392.78
4321993-32199392.15992.16
5328781-32878194.10294.10
6326303-32630393.39393.39
10min1345022-34502298.751100.431.2699.26100.951.25
2353968-353968101.311101.84
3354162-354162101.367101.88
4355260-355260101.681102.19
5350877-350877100.427100.95
6346137-34613799.07099.59
15min1352031-352031100.757101.570.94101.81102.650.94
2356742-356742102.105103.20
3356265-356265101.969103.05
4360005-360005103.039104.12
5352439-352439100.874101.95
6351786-351786100.687101.76
20min1351498-351498100.604100.610.84102.22102.250.83
2352055-352055100.764102.42
3354861-354861101.567103.21
4354101-354101101.349103.00
5346908-34690899.291100.93
6349668-349668100.081101.71
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