盐酸鲁拉西酮片项目信息
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%
110.841927371929601926951927951923251927020.13
210.831941921944741943330.11
单位质量响应值RSD%判断
17776.9417943.950.67数据可信
供试品溶液-24052101批-pH4.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min175963-7596338.18041.197.2138.1841.197.21
288201-8820144.33044.33
376415-7641538.40738.41
477567-7756738.98638.99
588043-8804344.25144.25
685470-8547042.95842.96
10min1102439-10243951.48754.295.1151.5554.355.11
2112959-11295956.77456.85
3101455-10145550.99251.06
4106027-10602753.29053.35
5114563-11456357.58057.65
6110603-11060355.59055.66
15min1118413-11841359.51561.453.8859.6661.613.89
2126963-12696363.81363.98
3115716-11571658.16058.31
4120968-12096860.79960.95
5127530-12753064.09864.27
6124024-12402462.33562.50
20min1128991-12899164.83266.273.1665.0866.533.17
2135562-13556268.13468.41
3126094-12609463.37663.62
4130184-13018465.43165.69
5137011-13701168.86369.14
6133262-13326266.97967.25
30min1141953-14195371.34772.232.8371.7072.602.84
2146833-14683373.79974.19
3137781-13778169.25069.60
4142202-14220271.47271.84
5149384-14938475.08275.47
6144120-14412072.43672.82
45min1152784-15278476.79077.902.1277.2778.402.13
2157288-15728879.05479.57
3150428-15042875.60676.07
4154053-15405377.42877.91
5159561-15956180.19780.71
6155863-15586378.33878.84
60min1159917-15991780.37682.124.1880.9882.744.17
2162790-16279081.82082.46
3157427-15742779.12479.72
4160553-16055380.69581.31
5176665-17666588.79389.44
6162972-16297281.91182.54
极限1169114-16911484.99886.161.6585.7486.921.66
2171688-17168886.29287.07
3167875-16787584.37585.10
4170778-17077885.83486.58
5175487-17548788.20189.00
6173571-17357187.23888.01
盐酸鲁拉西酮片项目信息
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%
110.841921281926251925301926421920961924040.15
210.831938791942481940640.14
单位质量响应值RSD%判断
17749.4517919.110.68数据可信
供试品溶液-24052102批-pH4.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1102367-10236751.52642.5011.2951.5342.5011.29
284872-8487242.72042.72
381345-8134540.94540.94
484751-8475142.65942.66
577345-7734538.93138.93
675933-7593338.22138.22
10min1114342-11434257.55454.413.3757.6454.483.38
2108799-10879954.76354.83
3106533-10653353.62353.69
4109338-10933855.03555.11
5104364-10436452.53152.60
6105159-10515952.93153.00
15min1127052-12705263.95161.172.7464.1361.332.75
2121682-12168261.24861.41
3119543-11954360.17160.33
4123472-12347262.14962.31
5117919-11791959.35459.51
6119490-11949060.14560.30
20min1135956-13595668.43366.042.2968.7266.302.31
2130979-13097965.92866.19
3129574-12957465.22065.48
4133468-13346867.18167.45
5127848-12784864.35264.60
6129353-12935365.10965.36
30min1146502-14650273.74171.791.6074.1472.171.61
2142475-14247571.71472.09
3140842-14084270.89271.26
4143772-14377272.36772.75
5140216-14021670.57770.94
6141975-14197571.46271.82
45min1156502-15650278.77577.441.2279.3077.941.23
2153885-15388577.45777.95
3152825-15282576.92477.41
4155600-15560078.32178.82
5151639-15163976.32776.80
6152670-15267076.84677.33
60min1162360-16236081.72380.940.8782.3881.560.88
2160705-16070580.89081.51
3158832-15883279.94780.56
4162383-16238381.73582.36
5159846-15984680.45881.06
6160754-16075480.91581.52
极限1170927-17092786.03585.450.6686.8386.210.67
2169441-16944185.28786.05
3168017-16801784.57185.32
4170948-17094886.04686.81
5169959-16995985.54886.29
6169332-16933285.23285.98
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