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%
113.521755517567175951754117559175630.12
213.561768817717177020.12
单位质量响应值RSD%判断
1299.041305.460.35数据可信
供试品溶液-2024081611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%
2min114250-1425078.31584.905.7378.3184.905.73
214397-1439779.12279.12
315810-1581086.88886.89
416196-1619689.00989.01
516138-1613888.69188.69
615903-1590387.39987.40
5min117781-1778197.72094.782.1097.7294.782.10
216793-1679392.29092.29
317250-1725094.80294.80
417418-1741895.72595.73
516893-1689392.84092.84
617343-1734395.31395.31
10min117516-1751696.26494.641.5896.2694.641.58
216872-1687292.72492.72
317247-1724794.78594.79
417423-1742395.75395.75
516909-1690992.92892.93
617357-1735795.39095.39
15min117523-1752396.30295.141.3996.3095.141.39
217156-1715694.28594.29
317395-1739595.59995.60
417498-1749896.16596.16
516900-1690092.87892.88
617393-1739395.58895.59
30min117494-1749496.14394.741.3596.1494.741.35
216984-1698493.34093.34
317212-1721294.59394.59
417443-1744395.86395.86
516949-1694993.14893.15
617353-1735395.36895.37
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%
113.521757117591175801760517563175820.10
213.561754517535175400.05
单位质量响应值RSD%判断
1300.441293.510.38数据可信
供试品溶液-2024081611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%
2min115249-1524984.14685.324.7184.1585.324.71
214591-1459180.51580.51
315687-1568786.56286.56
415109-1510983.37383.37
515385-1538584.89684.90
616751-1675192.43492.43
5min117432-1743296.19297.264.3296.1997.264.32
216714-1671492.23092.23
317679-1767997.55597.55
417653-1765397.41197.41
517270-1727095.29895.30
619003-19003104.860104.86
10min117573-1757396.97097.524.6096.9797.524.60
216652-1665291.88791.89
317716-1771697.75997.76
417898-1789898.76398.76
517146-1714694.61394.61
619057-19057105.158105.16
15min117552-1755296.85497.424.3896.8597.424.38
216804-1680492.72692.73
317685-1768597.58897.59
417684-1768497.58297.58
517137-1713794.56494.56
619063-19063105.192105.19
30min117787-1778798.15097.925.0398.1597.925.03
216740-1674092.37392.37
317702-1770297.68197.68
417718-1771897.77097.77
517162-1716294.70294.70
619366-19366106.864106.86
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%
113.521754017568175651757617580175660.09
213.561760817587175980.09
单位质量响应值RSD%判断
1299.261297.790.09数据可信
供试品溶液-2024081711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%
2min115780-1578086.97189.654.6886.9789.654.68
216636-1663691.68991.69
317104-1710494.26994.27
417064-1706494.04894.05
515601-1560185.98585.98
615410-1541084.93284.93
5min119258-19258106.140102.133.16106.14102.133.16
219085-19085105.187105.19
318312-18312100.926100.93
417769-1776997.93497.93
518689-18689103.004103.00
618067-1806799.57699.58
10min118457-18457101.726101.252.33101.73101.252.33
218692-18692103.021103.02
318340-18340101.081101.08
417857-1785798.41998.42
518955-18955104.470104.47
617927-1792798.80498.80
15min118516-18516102.051101.522.38102.05101.522.37
218811-18811103.677103.68
318317-18317100.954100.95
417819-1781998.20998.21
518972-18972104.564104.56
618082-1808299.65999.66
30min118458-18458101.731101.262.33101.73101.262.33
218723-18723103.192103.19
318314-18314100.937100.94
417878-1787898.53498.53
518945-18945104.415104.42
617921-1792198.77198.77
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%
113.521772117759177521776217762177510.10
213.561771817677176980.17
单位质量响应值RSD%判断
1312.941305.160.43数据可信
供试品溶液-2024081711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%
2min116324-1632489.24782.0126.8789.2582.0126.87
26976-697638.13938.14
316658-1665891.07391.07
418040-1804098.62898.63
516727-1672791.45091.45
615281-1528183.54483.54
5min119248-19248105.23399.543.41105.2399.543.41
218307-18307100.088100.09
317919-1791997.96797.97
418200-1820099.50399.50
518216-1821699.59199.59
617345-1734594.82994.83
10min118477-18477101.01899.092.49101.0299.092.49
218575-18575101.553101.55
317751-1775197.04897.05
418200-1820099.50399.50
518330-18330100.214100.21
617415-1741595.21195.21
15min118403-18403100.61399.022.21100.6199.022.21
218608-18608101.734101.73
317885-1788597.78197.78
418071-1807198.79898.80
518224-1822499.63499.63
617476-1747695.54595.54
30min118443-18443100.83299.242.30100.8399.242.30
218679-18679102.122102.12
317797-1779797.30097.30
418115-1811599.03899.04
518316-18316100.137100.14
617559-1755995.99996.00
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