普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.271682516838168121683416775168170.16
213.241678716791167890.02
单位质量响应值RSD%判断
1267.291268.050.05数据可信
供试品溶液-HH6848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%
2min111412-1141264.42861.614.7564.4361.624.75
210059-1005956.78956.79
310796-1079660.95060.95
411428-1142864.51864.52
511099-1109962.66162.66
610688-1068860.34060.34
5min116610-1661093.77494.860.9293.8894.960.92
216680-1668094.16994.26
316862-1686295.19695.30
417048-1704896.24796.35
516842-1684295.08495.19
616775-1677594.70594.81
10min117665-1766599.730100.230.6899.99100.490.68
217717-17717100.023100.28
317639-1763999.58399.84
417973-17973101.469101.74
517776-17776100.357100.62
617749-17749100.204100.46
15min117762-17762100.278100.460.71100.71100.890.71
217824-17824100.628101.05
317635-1763599.56199.99
417984-17984101.531101.97
517869-17869100.882101.31
617693-1769399.888100.31
30min117702-1770299.939100.510.79100.54101.100.78
217838-17838100.707101.29
317617-1761799.459100.05
418024-18024101.757102.36
517846-17846100.752101.35
617793-17793100.453101.04
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.271673216736167191672516751167330.08
213.241677016792167810.10
单位质量响应值RSD%判断
1260.961267.450.37数据可信
供试品溶液-HH6848批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min114247-1424780.65476.513.8080.6576.513.80
213513-1351376.49976.50
314020-1402079.36979.37
413009-1300973.64673.65
513099-1309974.15574.16
613204-1320474.75074.75
5min117591-1759199.58598.750.8799.7298.880.87
217319-1731998.04598.17
317330-1733098.10898.24
417290-1729097.88198.00
517501-1750199.07699.20
617632-1763299.81799.94
10min117622-1762299.76199.490.89100.0699.780.89
217419-1741998.61198.90
317601-1760199.64299.94
417413-1741398.57798.86
517551-1755199.35999.65
617834-17834100.961101.25
15min117636-1763699.84099.270.96100.3199.720.96
217362-1736298.28998.74
317535-1753599.26899.73
417388-1738898.43698.89
517477-1747798.94099.39
617809-17809100.819101.28
30min117801-17801100.77499.311.24101.4199.931.24
217319-1731998.04598.66
317509-1750999.12199.75
417327-1732798.09198.70
517495-1749599.04299.66
617802-17802100.780101.41
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.271675116765167361676016744167510.08
213.241669416715167040.09
单位质量响应值RSD%判断
1262.321261.630.04数据可信
供试品溶液-HH6848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%
2min110847-1084761.51460.932.4161.5160.932.41
210405-1040559.00859.01
310967-1096762.19562.20
411049-1104962.66062.66
510489-1048959.48459.48
610705-1070560.70960.71
5min116758-1675895.03693.621.4695.1493.721.46
216256-1625692.18992.29
316382-1638292.90493.01
416589-1658994.07894.18
516796-1679695.25295.35
616270-1627092.26992.37
10min117800-17800100.946100.471.94101.21100.731.94
217378-1737898.55298.80
317753-17753100.679100.94
417929-17929101.677101.94
518180-18180103.101103.36
617261-1726197.88998.14
15min117875-17875101.371101.052.12101.80101.482.12
217496-1749699.22299.64
317821-17821101.065101.49
418099-18099102.641103.07
518322-18322103.906104.34
617298-1729898.09998.52
30min117899-17899101.507100.952.20102.11101.542.19
217477-1747799.11499.70
317777-17777100.815101.41
418034-18034102.273102.87
518353-18353104.082104.68
617265-1726597.91298.49
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.271670816721167321674116719167240.08
213.241668816710166990.10
单位质量响应值RSD%判断
1260.291261.250.06数据可信
供试品溶液-HH6848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%
2min110340-1034058.69558.752.2758.7058.752.27
210555-1055559.91659.92
310001-1000156.77156.77
410627-1062760.32560.32
510402-1040259.04759.05
610175-1017557.75957.76
5min116212-1621292.02892.201.9292.1392.291.92
216003-1600390.84290.94
316300-1630092.52792.62
415806-1580689.72389.82
516680-1668094.68594.78
616449-1644993.37393.47
10min117078-1707896.94498.261.8397.2098.511.82
216998-1699896.49096.74
317376-1737698.63598.88
417089-1708997.00697.26
517815-17815101.127101.38
617504-1750499.36299.61
15min117126-1712697.21698.401.5897.6398.811.58
217046-1704696.76297.17
317374-1737498.62499.04
417174-1717497.48997.90
517767-17767100.855101.28
617516-1751699.43099.85
30min117060-1706096.84298.361.6997.4298.941.69
217070-1707096.89897.47
317315-1731598.28998.87
417190-1719097.58098.15
517816-17816101.133101.73
617509-1750999.39099.97
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