磷酸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500
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%
19.85 3062223062703064803057413058253061080.11
29.843070023070283070150.01
单位质量响应值RSD%判断
31076.9531200.710.29数据可信
供试品溶液-2024051421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1335921-33592198.24596.405.1498.2596.405.14
2330703-33070396.71996.72
3338673-33867399.05099.05
4317647-31764792.90192.90
5303369-30336988.72588.72
6351462-351462102.790102.79
10min1348422-348422101.901101.942.66102.45102.482.68
2353116-353116103.274103.81
3353338-353338103.339103.89
4342870-342870100.278100.79
5333640-33364097.57898.07
6360008-360008105.290105.86
15min1353183-353183103.294102.652.20104.41103.752.21
2356627-356627104.301105.41
3351590-351590102.828103.95
4341674-34167499.928101.00
5342118-342118100.058101.09
6360667-360667105.483106.64
20min1345966-345966101.183102.141.52102.87103.811.53
2353359-353359103.345105.04
3344250-344250100.681102.38
4349100-349100102.100103.73
5345054-345054100.916102.51
6357612-357612104.589106.33
极限1347503-347503101.633101.711.83103.88103.951.82
2342465-342465100.159102.42
3353866-353866103.494105.75
4338342-33834298.953101.15
5350212-350212102.425104.58
6354232-354232103.601105.92
磷酸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500
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%
19.85 3069453071903070883070263071793070860.04
29.843062133066443064280.10
单位质量响应值RSD%判断
31176.2431141.060.08数据可信
供试品溶液-2024051421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1346034-346034101.13897.742.32101.1497.742.32
2327775-32777595.80295.80
3334612-33461297.80097.80
4335229-33522997.98097.98
5338572-33857298.95798.96
6324299-32429994.78694.79
10min1345986-345986101.124101.170.74101.69101.710.74
2347341-347341101.520102.05
3348507-348507101.861102.40
4346759-346759101.350101.89
5346997-346997101.420101.97
6341214-34121499.729100.26
15min1348294-348294101.799101.160.90102.92102.260.89
2349384-349384102.117103.21
3342758-342758100.181101.29
4348886-348886101.972103.08
5342833-342833100.203101.32
6344502-344502100.690101.77
20min1341265-34126599.744100.400.69101.43102.060.68
2346194-346194101.185102.85
3344518-344518100.695102.36
4345982-345982101.123102.80
5341844-34184499.914101.58
6341178-34117899.719101.36
极限1343170-343170100.301100.211.04102.54102.441.02
2344616-344616100.724102.95
3348483-348483101.854104.08
4342372-342372100.068102.30
5340188-34018899.430101.65
6338362-33836298.896101.09
磷酸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500
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%
19.85 3066883064453063283058583055893061820.15
29.843062363057173059760.12
单位质量响应值RSD%判断
31084.4731095.120.03数据可信
供试品溶液-2024051621批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343549-343549100.63498.683.36100.6398.683.36
2344541-344541100.925100.92
3339476-33947699.44199.44
4314769-31476992.20492.20
5343195-343195100.531100.53
6335685-33568598.33198.33
10min1358066-358066104.887102.561.67105.45103.101.67
2347152-347152101.690102.25
3353301-353301103.491104.04
4346198-346198101.410101.92
5353571-353571103.570104.13
6342373-342373100.290100.84
15min1353886-353886103.662102.731.06104.80103.851.06
2348659-348659102.131103.26
3351999-351999103.110104.24
4351672-351672103.014104.09
5353837-353837103.648104.78
6344197-344197100.824101.93
20min1354927-354927103.967102.441.18105.68104.121.17
2346400-346400101.469103.16
3352119-352119103.145104.84
4352302-352302103.198104.85
5348343-348343102.039103.75
6344113-344113100.800102.46
极限1342786-342786100.411101.031.52102.71103.291.49
2340444-34044499.725101.98
3350106-350106102.555104.83
4352510-352510103.259105.48
5343897-343897100.736103.01
6339719-33971999.512101.74
磷酸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500
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%
19.85 3063203068573071063060993056433064050.20
29.843059683068363064020.21
单位质量响应值RSD%判断
31107.1131138.410.08数据可信
供试品溶液-2024051621批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347013-347013101.54197.844.71101.5497.844.71
2355265-355265103.956103.96
3327026-32702695.69395.69
4334975-33497598.01998.02
5310342-31034290.81190.81
6331521-33152197.00897.01
10min1341617-34161799.962101.432.14100.53101.972.14
2351752-351752102.928103.51
3345223-345223101.018101.55
4359136-359136105.089105.63
5340412-34041299.610100.11
6341578-34157899.951100.49
15min1343623-343623100.549101.212.20101.67102.322.19
2348408-348408101.950103.10
3348551-348551101.991103.08
4357496-357496104.609105.74
5342356-342356100.179101.24
6334872-33487297.98999.08
20min1337283-33728398.694100.862.27100.37102.522.24
2342803-342803100.309102.03
3351469-351469102.845104.50
4354473-354473103.724105.43
5347191-347191101.593103.21
6334814-33481497.97299.61
极限1337981-33798198.898101.532.01101.12103.761.99
2348141-348141101.871104.14
3345421-345421101.076103.31
4357575-357575104.632106.92
5351118-351118102.743104.92
6341661-34166199.975102.16
磷酸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500
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%
19.85 3064033070353068653055393054993062680.24
29.843068263070183069220.05
单位质量响应值RSD%判断
31093.2031191.260.23数据可信
供试品溶液-2024051721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340021-34002199.43397.535.6499.4397.535.64
2357303-357303104.487104.49
3306045-30604589.49889.50
4348885-348885102.026102.03
5323441-32344194.58594.58
6325447-32544795.17195.17
10min1351400-351400102.761101.851.50103.31102.391.51
2356732-356732104.320104.90
3341791-34179199.951100.45
4348038-348038101.778102.34
5345578-345578101.058101.58
6346234-346234101.250101.78
15min1346319-346319101.275102.281.52102.40103.391.51
2359882-359882105.241106.40
3351317-351317102.737103.79
4346752-346752101.402102.53
5346806-346806101.418102.50
6347513-347513101.624102.72
20min1343459-343459100.439101.200.86102.12102.870.83
2346162-346162101.229102.97
3351289-351289102.729104.35
4344497-344497100.742102.44
5343616-343616100.485102.14
6347306-347306101.564103.22
极限1348713-348713101.975101.452.05104.22103.692.02
2350066-350066102.371104.68
3355830-355830104.056106.25
4349277-349277102.140104.40
5335433-33543398.092100.30
6342167-342167100.061102.28
磷酸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500
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%
19.85 3061943065903061083061713061223062370.07
29.843053883051393052640.06
单位质量响应值RSD%判断
31090.0531022.760.16数据可信
供试品溶液-2024051721批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1328457-32845796.31796.033.3796.3296.033.37
2306363-30636389.83889.84
3334082-33408297.96697.97
4326817-32681795.83695.84
5331794-33179497.29697.30
6337315-33731598.91598.91
10min1349496-349496102.487101.281.19103.02101.821.20
2338605-33860599.29399.79
3348113-348113102.081102.63
4343202-343202100.641101.17
5344662-344662101.069101.61
6348274-348274102.128102.68
15min1354342-354342103.908100.992.11105.01102.082.11
2332454-33245497.48998.54
3346511-346511101.611102.72
4340967-34096799.985101.08
5346295-346295101.548102.65
6345726-345726101.381102.50
20min1340753-34075399.923100.451.61101.60102.111.57
2348290-348290102.133103.73
3350073-350073102.656104.33
4341630-341630100.180101.83
5338386-33838699.229100.89
6336262-33626298.606100.29
极限1342940-342940100.56499.632.12102.80101.852.08
2339401-33940199.526101.69
3345042-345042101.180103.43
4325932-32593295.57797.78
5340236-34023699.771101.99
6345009-345009101.171103.40
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