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对照品来源中检院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%
113.091635316342163801634416384163610.13
213.011647716379164280.43
单位质量响应值RSD%判断
1249.891262.720.73数据可信
供试品溶液-2024121521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%
2min117026-1702696.99594.602.0596.9994.602.05
216384-1638493.33793.34
316291-1629192.80892.81
416480-1648093.88493.88
517050-1705097.13297.13
616404-1640493.45193.45
5min118442-18442105.062102.112.30105.06102.112.30
218238-18238103.899103.90
317808-17808101.450101.45
417460-1746099.46799.47
518124-18124103.250103.25
617468-1746899.51399.51
10min117873-17873101.820101.651.96101.82101.651.96
218305-18305104.281104.28
317855-17855101.717101.72
417388-1738899.05799.06
518127-18127103.267103.27
617514-1751499.77599.77
15min118016-18016102.63599.993.14102.6399.993.14
218315-18315104.338104.34
317443-1744399.37099.37
416813-1681395.78195.78
517574-17574100.117100.12
617151-1715197.70797.71
30min118129-18129103.278100.442.70103.28100.442.70
218205-18205103.711103.71
317525-1752599.83899.84
417064-1706497.21197.21
517689-17689100.772100.77
617171-1717197.82197.82
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对照品来源中检院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%
113.091644016372163681639216405163950.18
213.011652316521165220.01
单位质量响应值RSD%判断
1252.481269.950.98数据可信
供试品溶液-2024121521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%
2min116166-1616691.73993.335.3691.7493.335.36
216807-1680795.37695.38
315419-1541987.50087.50
415843-1584389.90689.91
516501-1650193.64093.64
617945-17945101.834101.83
5min118160-18160103.054101.962.46103.05101.962.46
217916-17916101.670101.67
317626-17626100.024100.02
417609-1760999.92899.93
517730-17730100.614100.61
618761-18761106.465106.46
10min117972-17972101.988101.832.35101.99101.842.35
217954-17954101.885101.89
317635-17635100.075100.08
417643-17643100.121100.12
517717-17717100.540100.54
618749-18749106.397106.40
15min118014-18014102.226101.972.60102.23101.972.60
218052-18052102.442102.44
317635-17635100.075100.08
417581-1758199.76999.77
517696-17696100.421100.42
618831-18831106.862106.86
30min118064-18064102.510102.022.47102.51102.022.47
218096-18096102.691102.69
317634-17634100.069100.07
417672-17672100.285100.29
517634-17634100.069100.07
618771-18771106.522106.52
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对照品来源中检院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%
113.091650216512164601638316435164580.32
213.011651916373164460.63
单位质量响应值RSD%判断
1257.301264.100.39数据可信
供试品溶液-2024121621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%
2min115025-1502585.29591.183.3685.3091.183.35
216448-1644893.37393.37
316179-1617991.84691.85
415960-1596090.60390.60
516363-1636392.89192.89
616393-1639393.06193.06
5min117715-17715100.56698.152.48100.5798.152.48
217860-17860101.389101.39
317301-1730198.21698.22
416736-1673695.00895.01
517052-1705296.80296.80
617069-1706996.89996.90
10min117510-1751099.40298.202.4699.4098.202.46
217964-17964101.980101.98
317408-1740898.82398.82
416745-1674595.05995.06
517036-1703696.71196.71
617130-1713097.24597.25
15min117531-1753199.52298.933.2799.5298.933.27
218410-18410104.511104.51
317585-1758599.82899.83
416755-1675595.11695.12
517097-1709797.05897.06
617183-1718397.54697.55
30min117509-1750999.39799.043.5999.4099.043.59
218506-18506105.056105.06
317729-17729100.646100.65
416734-1673494.99795.00
517129-1712997.23997.24
617065-1706596.87696.88
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对照品来源中检院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%
113.091648716411164661651016516164780.26
213.011648716544165160.25
单位质量响应值RSD%判断
1258.821269.490.60数据可信
供试品溶液-2024121621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%
2min116358-1635892.61090.562.5792.6190.562.57
216521-1652193.53393.53
315787-1578789.37789.38
415372-1537287.02887.03
515986-1598690.50490.50
615948-1594890.28990.29
5min118332-18332103.785100.662.29103.79100.662.29
217580-1758099.52899.53
317181-1718197.26997.27
417617-1761799.73899.74
517905-17905101.368101.37
618063-18063102.263102.26
10min118302-18302103.616100.882.09103.62100.882.09
217672-17672100.049100.05
317197-1719797.36097.36
417796-17796100.751100.75
517982-17982101.804101.80
617960-17960101.679101.68
15min118176-18176102.902100.361.94102.90100.361.93
217537-1753799.28599.28
317216-1721697.46797.47
417622-1762299.76699.77
517833-17833100.960100.96
617982-17982101.804101.80
30min118229-18229103.202100.402.24103.20100.402.24
217514-1751499.15499.15
317131-1713196.98696.99
417658-1765899.97099.97
517792-17792100.728100.73
618080-18080102.359102.36
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对照品来源中检院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%
113.091639916412164291638916432164120.12
213.011639316520164560.55
单位质量响应值RSD%判断
1253.781264.870.63数据可信
供试品溶液-2024121721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%
2min115791-1579189.74392.002.1489.7492.002.14
215892-1589290.31790.32
316182-1618291.96591.96
416773-1677395.32395.32
516283-1628392.53992.54
616209-1620992.11892.12
5min117494-1749499.42198.031.0899.4298.031.08
217315-1731598.40498.40
317285-1728598.23398.23
417326-1732698.46698.47
517124-1712497.31897.32
616956-1695696.36396.36
10min117545-1754599.71198.531.4799.7198.531.47
217506-1750699.48999.49
317490-1749099.39899.40
417432-1743299.06999.07
517123-1712397.31297.31
616923-1692396.17696.18
15min117506-1750699.48998.221.7999.4998.221.79
217533-1753399.64399.64
317484-1748499.36499.36
417393-1739398.84798.85
516929-1692996.21096.21
616854-1685495.78495.78
30min117460-1746099.22897.381.4699.2397.381.46
217088-1708897.11497.11
317182-1718297.64897.65
417338-1733898.53498.53
516974-1697496.46696.47
616770-1677095.30695.31
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对照品来源中检院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%
113.091650416504163681639616512164570.42
213.011640616485164460.34
单位质量响应值RSD%判断
1257.221264.100.39数据可信
供试品溶液-2024121721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%
2min115914-1591490.34589.951.0190.3489.951.01
215597-1559788.54588.55
315750-1575089.41489.41
415804-1580489.72089.72
516028-1602890.99290.99
615976-1597690.69790.70
5min117628-17628100.075101.360.82100.08101.360.82
217928-17928101.778101.78
317835-17835101.250101.25
418050-18050102.471102.47
517772-17772100.893100.89
617916-17916101.710101.71
10min117947-17947101.886102.060.71101.89102.060.71
217852-17852101.347101.35
317832-17832101.233101.23
418163-18163103.112103.11
518010-18010102.244102.24
618066-18066102.562102.56
15min117977-17977102.057102.280.86102.06102.280.86
218018-18018102.289102.29
317847-17847101.318101.32
418301-18301103.896103.90
517931-17931101.795101.80
618027-18027102.340102.34
30min118057-18057102.511102.380.82102.51102.380.82
218023-18023102.318102.32
317808-17808101.097101.10
418270-18270103.720103.72
518008-18008102.232102.23
618043-18043102.431102.43
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