佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
110.002164821462215422167821695216050.47
210.082156821784216760.71
单位质量响应值RSD%判断
2160.502150.400.34数据可信
供试品溶液-2025041221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%
5min17911-791132.94632.526.8332.9532.526.83
27777-777732.38832.39
38667-866736.09536.09
47974-797433.20933.21
57431-743130.94730.95
67099-709929.56529.56
10min113347-1334755.58556.835.2455.6456.885.24
213678-1367856.96457.02
314671-1467161.09961.16
414269-1426959.42559.48
513140-1314054.72354.77
612770-1277053.18253.23
15min116007-1600766.66367.883.8366.8168.033.83
216492-1649268.68368.83
317230-1723071.75771.92
416620-1662069.21669.37
516037-1603766.78866.93
615415-1541564.19864.34
20min117090-1709071.17474.083.4271.4374.343.43
218077-1807775.28475.55
318592-1859277.42977.71
418272-1827276.09676.37
517423-1742372.56072.81
617274-1727471.94072.18
30min119454-1945481.01981.332.4481.4081.722.45
219434-1943480.93581.32
320267-2026784.40584.82
419875-1987582.77283.17
519203-1920379.97380.35
618944-1894478.89579.26
45min120946-2094687.23286.661.8087.7487.191.81
220721-2072186.29586.82
321225-2122588.39488.95
421025-2102587.56188.10
520804-2080486.64187.15
620138-2013883.86784.36
60min121374-2137489.01588.821.5389.6789.491.55
221357-2135788.94489.61
321800-2180090.78991.49
421509-2150989.57790.26
521018-2101887.53288.18
620908-2090887.07487.71
90min122364-2236493.13891.611.3393.9492.421.33
221739-2173990.53591.35
322320-2232092.95593.80
422036-2203691.77292.60
521797-2179790.77691.58
621720-2172090.45691.24
极限122401-2240193.29291.321.5494.2592.281.54
221780-2178090.70691.67
321985-2198591.55992.56
422223-2222392.55193.53
521584-2158489.88990.84
621594-2159489.93190.86
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
110.002167121756218072176121818217630.27
210.082174021850217950.36
单位质量响应值RSD%判断
2176.302162.200.46数据可信
供试品溶液-2025041221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%
5min17611-761131.49529.677.7031.5029.677.70
27787-778732.22432.22
36890-689028.51228.51
47546-754631.22731.23
56417-641726.55526.55
66770-677028.01528.02
10min113512-1351255.91555.433.0555.9755.483.05
213787-1378757.05357.11
313583-1358356.20956.26
413664-1366456.54456.60
512701-1270152.55952.60
613124-1312454.30954.36
15min116429-1642967.98666.642.6668.1366.782.66
216212-1621267.08867.24
316348-1634867.65167.79
416492-1649268.24668.39
515494-1549464.11764.25
615642-1564264.72964.87
20min118207-1820775.34373.701.9975.6073.952.00
217956-1795674.30574.57
317718-1771873.32073.57
418146-1814675.09175.35
517338-1733871.74771.99
617488-1748872.36872.61
30min120159-2015983.42180.981.7483.8181.351.74
219555-1955580.92281.31
319588-1958881.05881.43
419636-1963681.25781.64
519219-1921979.53179.89
619252-1925279.66880.03
45min121077-2107787.22086.830.7887.7487.340.78
221009-2100986.93887.46
321117-2111787.38587.90
421123-2112387.41087.93
520726-2072685.76786.26
620850-2085086.28186.78
60min121953-2195390.84589.822.0691.5190.472.05
221257-2125787.96588.63
321530-2153089.09489.75
422403-2240392.70793.37
521254-2125487.95288.59
621831-2183190.34090.98
90min122315-2231592.34391.890.9893.1692.690.97
221899-2189990.62191.43
322034-2203491.18091.99
422507-2250793.13793.96
522187-2218791.81392.59
622290-2229092.23993.03
极限122251-2225192.07891.690.8593.0592.650.83
221902-2190290.63491.60
322074-2207491.34692.30
422126-2212691.56192.54
522130-2213091.57792.51
622460-2246092.94393.89
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