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%
111.181966101968751967481967351965681967070.07
211.221973151972701972920.02
单位质量响应值RSD%判断
17594.5417583.960.05数据可信
供试品溶液-25010302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%
5min190728-9072846.30344.175.4846.3044.175.48
281054-8105441.36641.37
381979-8197941.83841.84
483873-8387342.80442.80
590925-9092546.40346.40
690714-9071446.29646.30
10min1124586-12458663.58261.393.8063.6661.463.80
2115967-11596759.18359.25
3115304-11530458.84558.91
4117309-11730959.86859.94
5125032-12503263.81063.89
6123561-12356163.05963.14
15min1144904-14490473.95171.822.7874.1371.992.78
2137618-13761870.23370.40
3134935-13493568.86469.03
4140346-14034671.62571.80
5144412-14441273.70073.88
6142115-14211572.52872.71
20min1157012-15701280.13077.992.4480.4478.292.45
2151100-15110077.11377.40
3147543-14754375.29875.58
4150328-15032876.71977.01
5156001-15600179.61479.92
6154968-15496879.08779.39
30min1170047-17004786.78385.411.6687.2285.841.67
2166974-16697485.21485.63
3162687-16268783.02783.43
4166037-16603784.73685.15
5169678-16967886.59487.03
6168778-16877886.13586.57
45min1179718-17971891.71891.140.9392.3091.710.94
2178767-17876791.23391.79
3175948-17594889.79490.34
4178715-17871591.20691.77
5180724-18072492.23292.82
6177654-17765490.66591.24
60min1186111-18611194.98194.640.7695.7295.370.77
2185844-18584494.84595.55
3182604-18260493.19193.89
4185965-18596594.90695.62
5186206-18620695.02995.77
6185985-18598594.91795.65
极限1190648-19064897.29697.370.6398.1998.250.63
2191052-19105297.50398.37
3188529-18852996.21597.07
4191599-19159997.78298.65
5191068-19106897.51198.41
6191829-19182997.89998.79
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%
111.181965631964641966571963801959921964110.14
211.221970331968521969420.07
单位质量响应值RSD%判断
17568.0717552.760.07数据可信
供试品溶液-25010302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%
5min187297-8729744.62547.514.2944.6247.524.29
293675-9367547.88547.89
393725-9372547.91147.91
489354-8935445.67645.68
598117-9811750.15650.16
695520-9552048.82848.83
10min1121276-12127661.99464.523.2662.0764.603.26
2127448-12744865.14965.23
3126707-12670764.77164.85
4121399-12139962.05762.13
5131414-13141467.17767.26
6129039-12903965.96366.04
15min1142870-14287073.03374.522.4073.2174.712.41
2145779-14577974.52074.71
3147238-14723875.26675.45
4140588-14058871.86672.05
5150011-15001176.68376.88
6148176-14817675.74575.94
20min1154806-15480679.13479.533.3479.4379.843.33
2158043-15804380.78981.10
3159219-15921981.39081.70
4153915-15391578.67978.98
5161049-16104982.32682.65
6146505-14650574.89175.21
30min1169757-16975786.77787.631.1987.2188.071.20
2171583-17158387.71088.16
3172846-17284688.35688.80
4168243-16824386.00386.43
5173554-17355488.71889.18
6172570-17257088.21588.66
45min1180489-18048992.26393.251.1692.8493.841.17
2182406-18240693.24393.84
3184144-18414494.13194.73
4179465-17946591.74092.31
5184965-18496594.55195.16
6183076-18307693.58694.17
60min1186745-18674595.46196.050.6396.1996.800.63
2186844-18684495.51296.26
3189397-18939796.81797.57
4187149-18714995.66896.39
5189115-18911596.67397.44
6188181-18818196.19596.94
极限1191024-19102497.64898.360.6398.5499.270.64
2193050-19305098.68499.59
3193517-19351798.92399.84
4190792-19079297.53098.42
5193425-19342598.87699.80
6192724-19272498.51799.42
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