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%
111.151968921969661969231968931971901969730.07
211.181967431965531966480.07
单位质量响应值RSD%判断
17665.7417589.270.31数据可信
供试品溶液-25010301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%
5min187070-8707044.34041.7616.6944.3441.7616.69
286072-8607243.83143.83
384769-8476943.16843.17
493166-9316647.44447.44
586170-8617043.88143.88
654727-5472727.86927.87
10min1116056-11605659.10059.303.4759.1759.373.46
2118640-11864060.41660.49
3109818-10981855.92456.00
4122007-12200762.13162.21
5115314-11531458.72358.80
6116825-11682559.49259.54
15min1133480-13348067.97367.093.9068.1567.263.90
2132415-13241567.43167.60
3127310-12731064.83165.00
4139247-13924770.91071.09
5133341-13334167.90368.07
6124704-12470463.50463.65
20min1144692-14469273.68374.112.7973.9774.392.79
2145991-14599174.34574.63
3139491-13949171.03471.31
4152207-15220777.51077.81
5145780-14578074.23774.52
6145020-14502073.85074.10
30min1160277-16027781.62081.652.3882.0382.062.38
2160522-16052281.74482.15
3154352-15435278.60278.99
4166309-16630984.69185.12
5160896-16089681.93582.34
6159690-15969081.32181.70
45min1172660-17266087.92688.191.5288.4788.731.52
2173935-17393588.57589.12
3168728-16872885.92386.45
4176813-17681390.04090.61
5173123-17312388.16188.71
6173846-17384688.52989.04
60min1178011-17801190.65092.361.9191.3493.041.90
2182432-18243292.90293.60
3176900-17690090.08590.75
4185114-18511494.26894.99
5180756-18075692.04892.74
6184963-18496394.19194.85
极限1187906-18790695.68995.941.2996.5396.781.29
2188377-18837795.92996.78
3183960-18396093.68094.50
4190760-19076097.14398.02
5189432-18943296.46697.31
6190001-19000196.75697.57
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%
111.151970911968681972021967731970801970030.09
211.181977611977051977330.03
单位质量响应值RSD%判断
17668.4317686.310.08数据可信
供试品溶液-25010301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%
5min186638-8663843.99544.963.3643.9944.963.35
290870-9087046.14446.14
384100-8410042.70642.71
487728-8772844.54844.55
589753-8975345.57745.58
692164-9216446.80146.80
10min1113886-11388657.83259.372.1757.9059.442.18
2119107-11910760.48360.56
3114725-11472558.25858.33
4115295-11529558.54758.62
5119081-11908160.47060.55
6119368-11936860.61560.69
15min1134501-13450168.30068.592.2968.4768.762.29
2137811-13781169.98170.16
3130710-13071066.37566.54
4132280-13228067.17267.34
5136863-13686369.49969.68
6138212-13821270.18470.36
20min1144521-14452173.38874.291.8673.6774.581.86
2147115-14711574.70575.00
3142786-14278672.50772.79
4144797-14479773.52873.81
5148823-14882375.57375.87
6149776-14977676.05776.35
30min1159635-15963581.06382.181.4881.4782.591.48
2163126-16312682.83683.25
3158143-15814380.30580.71
4163552-16355283.05283.46
5164104-16410483.33283.75
6162467-16246782.50182.92
45min1171956-17195687.32087.871.6687.8688.421.65
2175702-17570289.22289.78
3170888-17088886.77787.31
4173277-17327787.99088.54
5176940-17694089.85090.41
6169490-16949086.06786.63
60min1178638-17863890.71392.161.3191.4092.851.31
2183245-18324593.05293.76
3179383-17938391.09191.77
4180359-18035991.58792.28
5184578-18457893.72994.44
6182684-18268492.76793.47
极限1187186-18718695.05395.860.9895.8996.710.99
2189222-18922296.08796.95
3186932-18693294.92495.75
4188154-18815495.54596.39
5191992-19199297.49498.36
6189161-18916196.05696.91
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