非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.971875661883431877981872561880371878000.23
210.991859501865391862440.23
单位质量响应值RSD%判断
17119.4216946.680.72数据可信
供试品溶液-BXK5AZ2批-pH4.5(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min178385-7838541.38537.1712.0241.3937.1812.02
262822-6282233.16833.17
378792-7879241.60041.60
476793-7679340.54540.54
565197-6519734.42234.42
660472-6047231.92831.93
10min1154541-15454181.59479.904.1481.6679.964.14
2146860-14686077.53877.59
3151166-15116679.81279.88
4162293-16229385.68785.75
5146462-14646277.32877.39
6146697-14669777.45277.51
15min1188523-18852399.53699.641.7199.7499.841.71
2187643-18764399.07199.26
3185543-18554397.96298.16
4194342-194342102.608102.82
5186113-18611398.26398.45
6190179-190179100.410100.59
20min1192579-192579101.677101.661.07102.05102.021.07
2192361-192361101.562101.91
3189472-189472100.037100.40
4195636-195636103.291103.67
5191610-191610101.165101.52
6193645-193645102.240102.59
30min1191988-191988101.365101.861.05101.91102.391.05
2193195-193195102.002102.52
3190399-190399100.526101.06
4196438-196438103.714104.27
5192218-192218101.486102.01
6193264-193264102.039102.56
45min1191943-191943101.341101.651.05102.05102.351.05
2192467-192467101.618102.31
3189365-18936599.980100.68
4195336-195336103.133103.86
5192157-192157101.454102.14
6193901-193901102.375103.07
60min1191003-191003100.845101.291.10101.72102.161.09
2192782-192782101.784102.64
3188345-18834599.442100.31
4194375-194375102.625103.52
5191493-191493101.104101.96
6193118-193118101.962102.82
极限1190549-190549100.605100.890.96101.65101.930.96
2190484-190484100.571101.60
3188476-18847699.511100.54
4193909-193909102.379103.45
5190950-190950100.817101.84
6192205-192205101.480102.51
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.971871311865571871001871831865641869070.17
210.991855261863461859360.32
单位质量响应值RSD%判断
17038.0116918.650.50数据可信
供试品溶液-BXK5AZ2批-pH4.5(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169236-6923636.67235.804.5436.6735.804.54
268020-6802036.02836.03
370628-7062837.41037.41
468481-6848136.27236.27
561764-6176432.71532.71
667355-6735535.67635.68
10min1148243-14824378.52077.995.1178.5878.055.11
2142676-14267675.57175.63
3157955-15795583.66483.73
4150833-15083379.89279.95
5135725-13572571.88971.94
6148030-14803078.40778.47
15min1189944-189944100.60899.442.22100.8099.632.22
2187037-18703799.06899.25
3193269-193269102.369102.57
4184580-18458097.76697.96
5181727-18172796.25596.43
6189848-189848100.557100.75
20min1192242-192242101.825100.831.59102.18101.181.59
2191256-191256101.303101.65
3193487-193487102.484102.86
4187364-18736499.24199.60
5185902-18590298.46798.80
6191911-191911101.649102.01
30min1192677-192677102.055101.211.54102.58101.741.54
2190822-190822101.073101.59
3194597-194597103.072103.62
4187981-18798199.568100.09
5187323-18732399.21999.72
6193114-193114102.287102.81
45min1192279-192279101.844101.081.32102.54101.781.33
2190959-190959101.145101.83
3193853-193853102.678103.39
4188323-18832399.749100.44
5187367-18736799.24399.91
6192290-192290101.850102.55
60min1191025-191025101.180100.711.42102.05101.571.42
2189806-189806100.535101.39
3193569-193569102.528103.41
4187049-18704999.07499.93
5187090-18709099.09699.93
6192282-192282101.846102.71
极限1191503-191503101.433100.401.27102.47101.431.28
2188630-18863099.912100.94
3192491-192491101.957103.01
4187901-18790199.525100.54
5186148-18614898.59799.59
6190674-190674100.994102.03
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