盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制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250
标示量(mg)40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%
111.532003072001122001612001072003532002080.06
211.582009742011592010660.07
单位质量响应值RSD%判断
17364.0917363.210.01数据可信
影响因素30天-供试品溶液-2025011721批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min177104-7710439.86139.475.9339.8639.475.93
274206-7420638.36338.36
371910-7191037.17637.18
473647-7364738.07438.07
584726-8472643.80143.80
676496-7649639.54739.55
10min1104571-10457154.06153.743.6854.1353.803.68
2103024-10302453.26153.32
3100162-10016251.78151.84
4101344-10134452.39252.46
5111046-11104657.40857.48
6103533-10353353.52453.59
15min1121428-12142862.77562.563.1262.9362.723.12
2119450-11945061.75361.91
3118111-11811161.06161.21
4118354-11835461.18661.34
5128270-12827066.31366.48
6120487-12048762.28962.44
20min1133603-13360369.07069.272.6069.3369.522.61
2134400-13440069.48269.74
3131071-13107167.76168.01
4130738-13073867.58867.84
5140397-14039772.58272.86
6133677-13367769.10869.37
30min1149255-14925577.16178.022.4277.5478.402.41
2154798-15479880.02780.40
3151266-15126678.20178.56
4145737-14573775.34375.71
5155236-15523680.25380.65
6149258-14925877.16377.54
45min1163185-16318584.36384.521.9384.8785.021.94
2165382-16538285.49986.00
3161327-16132783.40283.90
4159533-15953382.47582.97
5168537-16853787.13087.66
6162955-16295584.24484.75
60min1172319-17231989.08588.831.8589.7389.481.86
2173988-17398889.94890.60
3170636-17063688.21588.85
4166958-16695886.31386.94
5176244-17624491.11491.79
6170847-17084788.32488.97
极限1180487-18048793.30892.681.9394.1093.481.93
2181675-18167593.92294.72
3177142-17714291.57892.36
4174012-17401289.96090.73
5183685-18368594.96195.79
6178650-17865092.35893.15
盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制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250
标示量(mg)40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%
111.532019102017542015282017312015222016890.09
211.582010942013622012280.10
单位质量响应值RSD%判断
17492.5417377.200.47数据可信
影响因素30天-供试品溶液-2025011721批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1121994-12199462.81166.244.3362.8166.244.33
2129758-12975866.80966.81
3132130-13213068.03068.03
4135898-13589869.97069.97
5129999-12999966.93366.93
6122110-12211062.87162.87
10min1145467-14546774.89777.301.8575.0077.411.85
2150373-15037377.42377.53
3150110-15011077.28777.40
4152602-15260278.57078.69
5149122-14912276.77876.89
6153176-15317678.86678.97
15min1155956-15595680.29782.171.9480.5382.411.94
2160097-16009782.42982.67
3161797-16179783.30483.55
4164151-16415184.51684.76
5156821-15682180.74280.98
6158769-15876981.74581.98
20min1165975-16597585.45685.971.1385.8286.341.13
2167365-16736586.17186.55
3168296-16829686.65187.03
4169381-16938187.20987.60
5163995-16399584.43684.81
6166793-16679385.87786.25
30min1172311-17231188.71889.941.1289.2290.461.12
2174821-17482190.01090.53
3175092-17509290.15090.68
4177247-17724791.25991.79
5172552-17255288.84289.36
6176105-17610590.67191.19
45min1179674-17967492.50992.751.0393.1693.421.03
2181173-18117393.28193.95
3181893-18189393.65194.33
4178427-17842791.86792.55
5177622-17762291.45292.12
6182011-18201193.71294.38
60min1183471-18347194.46494.940.7295.2795.760.72
2184767-18476795.13195.96
3185732-18573295.62896.46
4184923-18492395.21196.05
5182204-18220493.81194.63
6185240-18524095.37596.20
极限1187600-18760096.59096.610.8797.5597.590.87
2189114-18911497.36998.35
3188771-18877197.19398.18
4187064-18706496.31497.31
5184715-18471595.10496.08
6188589-18858997.09998.08
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