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%
111.111979331979451978191982691975511979030.14
211.131997222000881999050.13
单位质量响应值RSD%判断
17813.0517960.920.59数据可信
供试品溶液-24052801批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1105349-10534952.87060.219.3652.8760.219.36
2107752-10775254.07654.08
3119765-11976560.10560.11
4125262-12526262.86462.86
5132027-13202766.25966.26
6129647-12964765.06565.06
10min1139398-13939869.95875.055.0270.0575.155.03
2142600-14260071.56571.66
3147601-14760174.07574.18
4153903-15390377.23877.34
5157275-15727578.93079.04
6156462-15646278.52278.63
15min1154061-15406177.31780.603.5677.5280.823.57
2154745-15474577.66077.87
3158083-15808379.33579.56
4163642-16364282.12582.36
5166668-16666883.64483.89
6166367-16636783.49383.73
20min1161248-16124880.92483.683.2281.2684.043.23
2160664-16066480.63180.97
3164235-16423582.42382.78
4169649-16964985.14085.51
5172481-17248186.56186.94
6172147-17214786.39486.77
30min1170466-17046685.55087.082.5886.0287.582.59
2167681-16768184.15284.63
3170846-17084685.74186.23
4175517-17551788.08588.60
5178118-17811889.39089.92
6178426-17842689.54590.07
45min1177567-17756789.11489.942.1989.7290.592.21
2173529-17352987.08787.70
3176707-17670788.68289.32
4181122-18112290.89891.56
5183040-18304091.86092.54
6183345-18334592.01392.69
60min1181576-18157691.12691.422.0091.8992.222.01
2176344-17634488.50089.26
3179805-17980590.23791.02
4184632-18463292.65993.47
5184904-18490492.79693.62
6185722-18572293.20694.03
极限1187459-18745994.07893.211.3094.9994.161.31
2181717-18171791.19692.10
3184975-18497592.83193.77
4187744-18774494.22195.19
5187812-18781294.25595.24
6184707-18470792.69793.68
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%
111.111994861993661993991985191981751989890.31
211.132031362030302030830.04
单位质量响应值RSD%判断
17910.8018246.451.32数据可信
供试品溶液-24052802批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115204-11520457.20754.179.1857.2154.179.18
291479-9147945.42645.43
3110077-11007754.66154.66
4115548-11554857.37857.38
5103925-10392551.60651.61
6118257-11825758.72358.72
10min1143743-14374371.37970.462.5171.4770.562.51
2136623-13662367.84367.92
3140954-14095469.99470.09
4142863-14286370.94271.04
5140146-14014669.59369.68
6147082-14708273.03773.13
15min1155316-15531677.12677.161.6477.3477.371.65
2151764-15176475.36275.55
3154144-15414476.54476.75
4155813-15581377.37377.59
5155740-15574077.33677.54
6159544-15954479.22579.44
20min1163305-16330581.09380.661.2981.4481.001.30
2159966-15996679.43579.75
3161690-16169080.29180.63
4162364-16236480.62680.97
5161208-16120880.05280.38
6166034-16603482.44882.80
30min1171856-17185685.33984.473.3685.8284.943.35
2169925-16992584.38084.83
3172892-17289285.85486.32
4172119-17211985.47085.95
5158934-15893478.92279.39
6174930-17493086.86687.35
45min1177672-17767288.22788.931.0088.8589.541.00
2177967-17796788.37488.96
3180498-18049889.63190.24
4179491-17949189.13189.75
5177206-17720687.99688.59
6181690-18169090.22390.86
60min1182136-18213690.44491.060.9591.2191.820.96
2182102-18210290.42791.16
3185216-18521691.97392.74
4183163-18316390.95491.72
5181837-18183790.29691.04
6185850-18585092.28893.07
极限1187028-18702892.87392.491.0193.7993.411.01
2185840-18584092.28393.17
3188660-18866093.68494.60
4185767-18576792.24793.17
5183107-18310790.92691.82
6187186-18718692.95293.89
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