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%
1 11.011974691975161973331975861976301975070.06
2 10.971975881975451975660.02
单位质量响应值RSD%判断
17938.8718009.660.28数据可信
供试品溶液-24071601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%
5min166115-6611533.01935.5611.7433.0235.5611.73
273309-7330936.61236.61
374341-7434137.12737.13
457559-5755928.74628.75
574051-7405136.98236.98
681904-8190440.90440.90
10min1105722-10572252.79953.054.9452.8553.104.96
2108473-10847354.17354.23
3104485-10448552.18152.24
497948-9794848.91748.96
5106655-10665553.26553.33
6114009-11400956.93857.01
15min1123527-12352761.69161.214.2561.8361.364.25
2126794-12679463.32363.47
3119276-11927659.56859.72
4114594-11459457.23057.36
5122183-12218361.02061.17
6129027-12902764.43864.60
20min1134498-13449867.17066.503.7467.4266.753.75
2138107-13810768.97369.23
3129196-12919664.52364.77
4125739-12573962.79663.02
5133074-13307466.45966.71
6138343-13834369.09169.36
30min1148479-14847974.15373.013.0974.5173.373.09
2151494-15149475.65976.03
3141887-14188770.86171.22
4140047-14004769.94270.27
5145633-14563372.73173.09
6149584-14958474.70575.09
45min1160551-16055180.18279.082.4780.6679.562.47
2163144-16314481.47781.97
3154734-15473477.27777.75
4152913-15291376.36776.81
5158018-15801878.91779.40
6160661-16066180.23780.75
60min1167703-16770383.75483.101.6684.3783.711.67
2170457-17045785.12985.76
3163524-16352481.66682.27
4163250-16325081.53082.10
5165947-16594782.87783.49
6167471-16747183.63884.28
极限1179654-17965489.72289.110.6890.4889.860.69
2180164-18016489.97790.75
3177406-17740688.59989.34
4177617-17761788.70589.41
5177409-17740988.60189.35
6178321-17832189.05689.84
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