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 3115653120443121293115433114093117380.11
29.843111353116713114030.13
单位质量响应值RSD%判断
31648.5331646.650.01数据可信
供试品溶液-2024042921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%
5min1314293-31429390.44294.053.1990.4494.053.19
2320408-32040892.20192.20
3317946-31794691.49391.49
4337953-33795397.25097.25
5336103-33610396.71896.72
6334310-33431096.20296.20
10min1350744-350744100.931101.433.17101.43101.953.17
2343496-34349698.84599.36
3343070-34307098.72399.23
4371296-371296106.845107.39
5359978-359978103.588104.13
6346196-34619699.622100.16
15min1356907-356907102.705101.313.88103.77102.403.86
2337080-33708096.99998.06
3342136-34213698.45499.51
4374927-374927107.890109.02
5356120-356120102.478103.59
6345285-34528599.360100.45
20min1357886-357886102.986101.673.34104.62103.323.33
2339664-33966497.74399.34
3344770-34477099.212100.82
4372942-372942107.319109.05
5355872-355872102.407104.09
6348748-348748100.357102.00
极限1352845-352845101.536100.363.87103.74102.573.85
2329037-32903794.68596.83
3344815-34481599.225101.38
4368869-368869106.147108.48
5354953-354953102.142104.39
6341930-34193098.395100.59
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 3111063111463108093105803106993108680.09
29.843121113115803118460.13
单位质量响应值RSD%判断
31560.2031691.670.30数据可信
供试品溶液-2024042921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%
5min1335441-33544196.59494.805.8496.5994.805.84
2302904-30290487.22587.22
3307819-30781988.64088.64
4343640-34364098.95598.95
5336249-33624996.82796.83
6349128-349128100.535100.54
10min1357498-357498102.945101.384.47103.48101.904.47
2332421-33242195.72496.21
3334032-33403296.18896.68
4361837-361837104.195104.74
5354656-354656102.127102.67
6371848-371848107.078107.64
15min1351505-351505101.220101.064.68102.33102.154.68
2336424-33642496.87797.89
3331113-33111395.34896.37
4358930-358930103.358104.49
5350689-350689100.985102.09
6376984-376984108.557109.71
20min1359387-359387103.489101.704.51105.16103.354.52
2334930-33493096.44798.00
3334723-33472396.38797.94
4360547-360547103.823105.53
5353860-353860101.898103.56
6375548-375548108.143109.90
极限1351666-351666101.26699.984.22103.51102.204.23
2334168-33416896.22798.32
3328252-32825294.52496.62
4353851-353851101.895104.17
5346223-34622399.699101.93
6369065-369065106.276108.63
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 3114493108413112373109213105933110080.11
29.843105413098753102080.16
单位质量响应值RSD%判断
31574.4231525.200.12数据可信
供试品溶液-2024042921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1313893-31389390.60793.903.0690.6193.903.06
2323030-32303093.24493.24
3329719-32971995.17595.17
4315205-31520590.98590.99
5330121-33012195.29195.29
6339908-33990898.11698.12
10min1349920-349920101.006102.332.74101.51102.862.74
2353399-353399102.010102.53
3353428-353428102.019102.55
4339828-33982898.09398.60
5364690-364690105.269105.80
6365857-365857105.606106.15
15min1351545-351545101.475102.672.25102.54103.762.25
2353546-353546102.053103.14
3356359-356359102.865103.96
4344146-34414699.339100.39
5361295-361295104.290105.40
6367176-367176105.987107.12
20min1349572-349572100.906102.702.80102.53104.362.80
2353979-353979102.178103.83
3351024-351024101.325102.99
4344282-34428299.379100.98
5366840-366840105.890107.58
6369060-369060106.531108.25
极限1344045-34404599.310102.123.17101.50104.363.16
2352457-352457101.738103.96
3351031-351031101.327103.56
4341470-34147098.567100.72
5363107-363107104.813107.09
6370656-370656106.992109.30
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