普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0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%
113.521724917290173501731117550173500.68
213.561732617359173420.14
单位质量响应值RSD%判断
1283.281278.910.25数据可信
供试品溶液-2024081211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%
2min114024-1402478.34586.025.5878.3486.025.58
215814-1581488.34588.34
316256-1625690.81490.81
415485-1548586.50786.51
516070-1607089.77589.77
614739-1473982.33982.34
5min117961-17961100.33997.402.80100.3497.402.80
216953-1695394.70894.71
317425-1742597.34497.34
417368-1736897.02697.03
518029-18029100.719100.72
616870-1687094.24494.24
10min117326-1732696.79197.022.3496.7997.022.34
217066-1706695.33995.34
317391-1739197.15597.15
417416-1741697.29497.29
518089-18089101.054101.05
616910-1691094.46794.47
15min117410-1741097.26197.181.9997.2697.181.99
217127-1712795.68095.68
317453-1745397.50197.50
417260-1726096.42396.42
518034-18034100.747100.75
617092-1709295.48495.48
30min117592-1759298.27797.062.4098.2897.062.39
217095-1709595.50195.50
317149-1714995.80395.80
417385-1738597.12197.12
518082-18082101.015101.01
616944-1694494.65794.66
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0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%
113.521734417293172941722817231172780.29
213.561727117201172360.29
单位质量响应值RSD%判断
1277.961271.090.39数据可信
供试品溶液-2024081211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%
2min114799-1479983.10185.913.7583.1085.913.75
214745-1474582.79882.80
315241-1524185.58385.58
416283-1628391.43491.43
515130-1513084.96084.96
615596-1559687.57687.58
5min117864-17864100.31297.812.99100.3197.822.99
217106-1710696.05596.06
316655-1665593.52393.52
417407-1740797.74697.75
517377-1737797.57797.58
618106-18106101.671101.67
10min117358-1735897.47198.372.4297.4798.372.42
217431-1743197.88097.88
316985-1698595.37695.38
417857-17857100.273100.27
517308-1730897.19097.19
618166-18166102.008102.01
15min117250-1725096.86498.752.8596.8698.752.84
217551-1755198.55498.55
316993-1699395.42195.42
418072-18072101.480101.48
517363-1736397.49997.50
618290-18290102.704102.70
30min117365-1736597.51099.612.4197.5199.612.41
217758-1775899.71799.72
317305-1730597.17397.17
418251-18251102.485102.49
517503-1750398.28598.28
618253-18253102.496102.50
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0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%
113.521723517383173991749417407173840.54
213.561713017205171680.31
单位质量响应值RSD%判断
1285.801266.081.10数据可信
供试品溶液-2024081511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%
2min115883-1588389.09485.314.5789.0985.314.57
216289-1628991.37191.37
314793-1479382.98082.98
414698-1469882.44782.45
514879-1487983.46283.46
614713-1471382.53182.53
5min119251-19251107.98698.265.17107.9998.265.17
217707-1770799.32599.33
316966-1696695.16995.17
417316-1731697.13297.13
516847-1684794.50194.50
617011-1701195.42195.42
10min118877-18877105.88897.864.35105.8997.864.35
217624-1762498.86098.86
316941-1694195.02995.03
417267-1726796.85796.86
516784-1678494.14894.15
617177-1717796.35296.35
15min118797-18797105.44098.124.43105.4498.124.43
217869-17869100.234100.23
317169-1716996.30896.31
417538-1753898.37798.38
516619-1661993.22293.22
616959-1695995.13095.13
30min118936-18936106.21997.794.71106.2297.794.71
217693-1769399.24799.25
317102-1710295.93295.93
417284-1728496.95396.95
516590-1659093.06093.06
616995-1699595.33295.33
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0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%
113.521738617306173871727117351173400.30
213.561713817263172000.52
单位质量响应值RSD%判断
1282.541268.440.79数据可信
供试品溶液-2024081511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%
2min115101-1510184.73588.997.6484.7388.987.64
217130-1713096.12096.12
317629-1762998.92098.92
414680-1468082.37282.37
515357-1535786.17186.17
615254-1525485.59385.59
5min117849-17849100.15499.975.16100.1599.975.16
218824-18824105.625105.63
318921-18921106.169106.17
416675-1667593.56793.57
517609-1760998.80798.81
617016-1701695.48095.48
10min117707-1770799.357100.205.0399.36100.205.03
218922-18922106.175106.17
318928-18928106.209106.21
416721-1672193.82593.82
517630-1763098.92598.93
617237-1723796.72096.72
15min117666-1766699.12799.965.3599.1399.965.35
218930-18930106.220106.22
318921-18921106.169106.17
416671-1667193.54493.54
517738-1773899.53199.53
616957-1695795.14995.15
30min117398-1739897.62399.605.3797.6299.605.37
218855-18855105.799105.80
318948-18948106.321106.32
416648-1664893.41593.42
517620-1762098.86998.87
617028-1702895.54795.55
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