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%
111.181945231941961942661927451945091940480.39
211.221943491935081939280.31
单位质量响应值RSD%判断
17356.7117284.140.30数据可信
供试品溶液-25010302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%
5min1102226-10222652.98156.784.4752.9856.784.47
2108458-10845856.21056.21
3113980-11398059.07259.07
4107043-10704355.47755.48
5109905-10990556.96056.96
6115778-11577860.00460.00
10min1152165-15216578.86279.581.4478.9579.681.45
2151510-15151078.52378.62
3155775-15577580.73380.83
4151454-15145478.49478.59
5153843-15384379.73279.83
6156535-15653581.12781.23
15min1172592-17259289.44989.090.8289.6789.320.82
2169838-16983888.02288.25
3173389-17338989.86290.10
4170808-17080888.52588.75
5173172-17317289.75089.98
6171639-17163988.95589.19
20min1182954-18295494.81994.210.5795.1994.590.57
2180632-18063293.61693.99
3181795-18179594.21994.60
4180544-18054493.57093.94
5182796-18279694.73895.11
6181986-18198694.31894.70
30min1191722-19172299.36498.670.5999.8999.200.59
2188884-18888497.89398.42
3190309-19030998.63199.17
4190164-19016498.55699.08
5191596-19159699.29899.83
6189571-18957198.24998.79
45min1196772-196772101.981100.850.66102.67101.540.65
2193218-193218100.139100.83
3194214-194214100.655101.36
4194127-194127100.610101.30
5195294-195294101.215101.92
6193877-193877100.480101.18
60min1198592-198592102.924101.550.76103.79102.410.75
2194858-194858100.989101.85
3195171-195171101.151102.02
4195290-195290101.213102.07
5196753-196753101.971102.84
6194930-194930101.026101.90
极限1198048-198048102.642102.061.09103.68103.091.08
2195732-195732101.442102.47
3195420-195420101.280102.32
4196757-196757101.973103.00
5200652-200652103.992105.03
6194922-194922101.022102.06
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%
111.181941241944281941711938351942391941590.12
211.221956541938411947480.66
单位质量响应值RSD%判断
17366.6417357.220.04数据可信
供试品溶液-25010302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%
5min1109970-10997056.85857.311.5756.8657.311.57
2112846-11284658.34558.34
3111126-11112657.45557.46
4108004-10800455.84155.84
5112295-11229558.06058.06
6110849-11084957.31257.31
10min1152088-15208878.63479.051.1178.7379.141.11
2155268-15526880.27880.38
3153102-15310279.15879.25
4151078-15107878.11278.20
5154431-15443179.84579.94
6151390-15139078.27378.37
15min1168655-16865587.19988.430.9687.4388.660.96
2172686-17268689.28389.51
3170930-17093088.37688.60
4170464-17046488.13588.36
5173087-17308789.49189.72
6170430-17043088.11788.34
20min1178256-17825692.16393.081.2092.5393.461.20
2182738-18273894.48194.86
3179950-17995093.03993.41
4178829-17882992.46092.83
5182564-18256494.39194.77
6177859-17785991.95892.33
30min1185957-18595796.14597.261.1196.6797.791.11
2191490-19149099.00699.54
3186957-18695796.66297.19
4186568-18656896.46196.99
5189466-18946697.95998.50
6188276-18827697.34497.87
45min1191046-19104698.77699.581.2099.46100.271.19
2196812-196812101.757102.46
3190871-19087198.68699.38
4191733-19173399.13199.82
5193642-193642100.118100.82
6191449-19144998.98499.67
60min1193066-19306699.821100.081.37100.67100.941.36
2197226-197226101.971102.84
3190885-19088598.69399.55
4191070-19107098.78999.64
5196260-196260101.472102.34
6192885-19288599.727100.58
极限1192847-19284799.707100.551.27100.72101.581.27
2198712-198712102.740103.78
3192814-19281499.690100.71
4192586-19258699.572100.59
5196190-196190101.436102.47
6193746-193746100.172101.19
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