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101096-202404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0.761
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952816512814832817162820882819962817870.09
214.982817632818082817860.02
单位质量响应值RSD%判断
18848.6318810.810.15数据可信
长期24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%
5min1279582-27958284.49096.896.6784.4996.886.67
2329370-32937099.53699.54
3342104-342104103.385103.38
4327835-32783599.07299.07
5322950-32295097.59697.60
6321752-32175297.23497.23
10min1311263-31126394.064102.665.1294.53103.205.12
2343186-343186103.712104.26
3363664-363664109.900110.47
4339840-339840102.700103.25
5347718-347718105.081105.62
6332645-332645100.526101.07
15min1309437-30943793.513101.094.9594.50102.204.96
2331045-331045100.043101.17
3356559-356559107.753108.94
4338829-338829102.395103.52
5346154-346154104.608105.73
6325059-32505998.23499.33
20min1306982-30698292.771101.475.3394.28103.135.33
2341567-341567103.222104.91
3360190-360190108.850110.63
4342998-342998103.655105.34
5336480-336480101.685103.39
6326301-32630198.609100.25
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101096-202404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0.761
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952813292818372813562811272808572813010.13
214.982848512845892847200.07
单位质量响应值RSD%判断
18816.1219006.680.72数据可信
长期24月-供试品溶液-2023071821批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1289980-28998087.25693.333.3287.2693.333.32
2312670-31267094.08494.08
3319646-31964696.18396.18
4314235-31423594.55594.55
5312886-31288694.14994.15
6311512-31151293.73593.74
10min1308824-30882492.92696.192.2093.4196.712.20
2321857-32185796.84897.37
3325856-32585698.05198.59
4327903-32790398.66799.19
5316606-31660695.26895.79
6316929-31692995.36595.89
15min1313091-31309194.21096.761.5695.2197.821.58
2324218-32421897.55998.62
3327569-32756998.56799.65
4324167-32416797.54398.62
5320179-32017996.34397.40
6320210-32021096.35397.40
20min1310404-31040493.40295.281.4494.9396.871.44
2320650-32065096.48598.09
3318143-31814395.73197.36
4321996-32199696.89098.51
5312593-31259394.06195.65
6316082-31608295.11096.70
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101096-202404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0.761
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952809052810612806222810732815582810440.13
214.982816232816102816160.01
单位质量响应值RSD%判断
18798.9318799.470.01数据可信
长期24月-供试品溶液-2023072021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1289907-28990787.75388.931.6687.7588.921.66
2292598-29259888.56788.57
3292227-29222788.45588.45
4298634-29863490.39490.39
5300754-30075491.03691.04
6288563-28856387.34687.35
10min1311026-31102694.14594.600.9794.6395.100.97
2315110-31511095.38195.87
3315053-31505395.36495.86
4311340-31134094.24094.74
5314952-31495295.33495.84
6307764-30776493.15893.64
15min1306474-30647492.76794.392.3193.7895.412.29
2319030-31903096.56897.59
3304566-30456692.19093.21
4321732-32173297.38698.41
5312552-31255294.60795.64
6306684-30668492.83193.83
20min1310430-31043093.96594.101.2795.4995.641.26
2315375-31537595.46297.02
3306429-30642992.75494.29
4313409-31340994.86796.43
5313551-31355194.91096.47
6306083-30608392.64994.17
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