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%
19.853025713025993030253028013027513027490.07
29.842969222969082969150.01
单位质量响应值RSD%判断
30735.9430174.291.31数据可信
供试品溶液-2024051421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%
5min1328679-32867998.29398.341.9098.2998.341.90
2326277-32627797.57597.57
3341299-341299102.067102.07
4326456-32645697.62897.63
5324920-32492097.16997.17
6325451-32545197.32897.33
10min1332397-33239799.405102.441.8899.95102.991.88
2346616-346616103.657104.20
3350120-350120104.705105.27
4346436-346436103.604104.15
5340229-340229101.747102.29
6339551-339551101.545102.09
15min1340443-340443101.811102.321.17102.91103.431.16
2346249-346249103.548104.67
3342263-342263102.356103.50
4346169-346169103.524104.64
5342131-342131102.316103.42
6335581-335581100.357101.46
20min1334381-33438199.998101.151.63101.66102.841.62
2339360-339360101.487103.18
3348498-348498104.220105.94
4335081-335081100.208101.90
5338261-338261101.159102.83
6333844-33384499.838101.50
极限1336050-336050100.498101.101.28102.72103.351.26
2340220-340220101.745104.00
3338402-338402101.201103.50
4345183-345183103.229105.48
5335721-335721100.399102.63
6332826-33282699.533101.75
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%
19.853030543031133031533029383030573030630.03
29.843028073023443025760.11
单位质量响应值RSD%判断
30767.8230749.590.05数据可信
供试品溶液-2024051421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%
5min1343315-343315101.64894.773.90101.6594.773.90
2313686-31368692.87692.88
3322656-32265695.53295.53
4315357-31535793.37093.37
5307265-30726590.97590.97
6318202-31820294.21394.21
10min1348485-348485103.17999.511.85103.74100.041.86
2335924-33592499.46099.98
3332966-33296698.58499.11
4331994-33199498.29698.82
5333857-33385798.84899.35
6333342-33334298.69599.22
15min1354459-354459104.948100.172.43106.09101.252.43
2338388-338388100.189101.26
3336269-33626999.562100.64
4333943-33394398.87399.94
5334924-33492499.164100.22
6331963-33196398.28799.36
20min1343118-343118101.59099.221.47103.31100.851.47
2336657-33665799.677101.30
3332114-33211498.33299.96
4328641-32864197.30498.92
5336151-33615199.527101.13
6333959-33395998.878100.50
极限1338118-338118100.11098.540.93102.39100.730.95
2334275-33427598.972101.15
3331597-33159798.179100.36
4329047-32904797.42499.58
5331910-33191098.271100.43
6332008-33200898.300100.47
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%
19.853042653045473044203041843042263043280.05
29.843022483019333020900.08
单位质量响应值RSD%判断
30896.2430700.200.46数据可信
供试品溶液-2024051621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%
5min1310120-31012091.70395.133.5991.7095.123.59
2339142-339142100.285100.28
3329397-32939797.40397.40
4318817-31881794.27594.27
5323477-32347795.65395.65
6309204-30920491.43291.43
10min1326739-32673996.61797.991.5197.1398.521.51
2337655-33765599.845100.40
3335388-33538899.17599.72
4329626-32962697.47197.99
5325156-32515696.14996.68
6333686-33368698.67299.18
15min1330509-33050997.73298.302.7498.7899.372.73
2345852-345852102.269103.38
3339985-339985100.534101.63
4324904-32490496.07597.14
5321763-32176395.14696.21
6331476-33147698.01899.07
20min1325016-32501696.10896.631.9697.7098.251.95
2331414-33141498.00099.68
3331466-33146698.01599.67
4325932-32593296.37997.98
5315246-31524693.21994.81
6331570-33157098.04699.65
极限1327016-32701696.69997.511.6598.8299.661.65
2337575-33757599.822102.05
3330421-33042197.70699.90
4323793-32379395.74697.88
5325261-32526196.18098.29
6334412-33441298.886101.03
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%
19.853025523023693025083022673024103024210.04
29.843019063017753018400.04
单位质量响应值RSD%判断
30702.6430674.800.07数据可信
供试品溶液-2024051621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%
5min1323059-32305995.86995.793.5795.8795.783.57
2326413-32641396.86496.86
3333046-33304698.83398.83
4319719-31971994.87894.88
5301835-30183589.57189.57
6332612-33261298.70498.70
10min1326745-32674596.96398.731.5397.5099.261.52
2331505-33150598.37598.91
3334951-33495199.39899.95
4327132-32713297.07897.60
5337849-337849100.258100.76
6338049-338049100.317100.87
15min1322299-32229995.64497.641.4496.7198.721.44
2327309-32730997.13098.21
3335851-33585199.665100.77
4327360-32736097.14598.21
5328578-32857897.50798.56
6332683-33268398.72599.83
20min1325075-32507596.46797.571.8898.0799.191.87
2323693-32369396.05797.68
3333493-33349398.965100.62
4322968-32296895.84297.45
5328887-32888797.59999.19
6338534-338534100.461102.12
极限1322134-32213495.59597.241.3097.7399.401.29
2325880-32588096.70698.86
3334517-33451799.269101.47
4326499-32649996.89099.03
5330318-33031898.023100.16
6326663-32666396.93999.15
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%
19.853027723027463027553027553026173027290.03
29.843015103015393015240.01
单位质量响应值RSD%判断
30733.9130642.680.22数据可信
供试品溶液-2024051721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%
5min1323693-32369396.05999.182.9696.0699.182.96
2350783-350783104.098104.10
3337246-337246100.081100.08
4324751-32475196.37396.37
5335846-33584699.66599.67
6332976-33297698.81498.81
10min1338596-338596100.481100.812.45101.01101.362.45
2356324-356324105.742106.32
3334485-33448599.26199.82
4337943-337943100.288100.82
5335650-33565099.607100.16
6335195-33519599.472100.02
15min1347989-347989103.269100.652.54104.36101.762.52
2345276-345276102.464103.63
3346128-346128102.716103.82
4328165-32816597.38698.48
5337229-337229100.076101.18
6330118-33011897.96599.07
20min1342634-342634101.680101.963.54103.35103.633.50
2348957-348957103.556105.29
3343806-343806102.027103.71
4332427-33242798.651100.28
5363632-363632107.911109.57
6330055-33005597.94799.59
极限1332472-33247298.66498.892.98100.89101.122.95
2350848-350848104.117106.43
3337855-337855100.261102.51
4327237-32723797.11099.29
5326143-32614396.78699.05
6324784-32478496.38298.57
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%
19.852958382963022960802960362958902960290.07
29.843017913016473017190.04
单位质量响应值RSD%判断
30053.7130662.501.42数据可信
供试品溶液-2024051721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%
5min1322577-32257796.77899.252.1796.7899.252.17
2329508-32950898.85898.86
3331126-33112699.34399.34
4324811-32481197.44897.45
5334422-334422100.332100.33
6342513-342513102.759102.76
10min1313885-31388594.17099.702.8594.71100.252.84
2338450-338450101.540102.09
3338143-338143101.448102.00
4333730-333730100.124100.67
5338126-338126101.443102.00
6331477-33147799.448100.02
15min1310736-31073693.22698.863.3794.2999.973.35
2342986-342986102.901104.01
3333171-33317199.957101.07
4326344-32634497.90899.01
5336792-336792101.043102.16
6327158-32715898.15399.28
20min1312419-31241993.73198.983.3195.31100.643.30
2334484-334484100.351102.04
3331850-33185099.560101.23
4322144-32214496.64898.29
5343052-343052102.921104.60
6335550-335550100.670102.34
极限1302823-30282390.85298.203.7792.95100.403.75
2332880-33288099.869102.11
3330301-33030199.096101.32
4331923-33192399.582101.76
5337233-337233101.175103.43
6328710-32871098.618100.85
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