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500
标示量(mg)20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%
111.193860583862193859223856913854103858600.09
211.173842773839633841200.06
单位质量响应值RSD%判断
34482.5734388.540.20数据可信
供试品溶液-BXK2XG1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%
5min1175961-17596145.95241.3514.2145.9541.3514.21
2138450-13845036.15636.16
3183798-18379847.99948.00
4144201-14420137.65837.66
5132204-13220434.52534.52
6175499-17549945.83145.83
10min1321506-32150683.96182.276.5184.0482.346.52
2304550-30455079.53379.59
3344052-34405289.84989.93
4304467-30446779.51179.57
5286686-28668674.86874.93
6328850-32885085.87985.96
15min1362959-36295994.78693.422.1095.0093.622.11
2354918-35491892.68792.88
3366203-36620395.63495.86
4355977-35597792.96393.16
5345122-34512290.12890.31
6361073-36107394.29494.51
20min1372716-37271697.33495.981.1597.7196.351.16
2366834-36683495.79896.15
3371468-37146897.00997.40
4365758-36575895.51795.87
5361038-36103894.28594.62
6367470-36747095.96496.34
30min1374723-37472397.85996.630.8498.4097.150.86
2368583-36858396.25596.76
3372722-37272297.33697.89
4367984-36798496.09996.61
5366501-36650195.71196.20
6369623-36962396.52797.06
45min1374812-37481297.88296.540.9598.5897.220.96
2369229-36922996.42497.09
3372859-37285997.37298.08
4366165-36616595.62496.29
5366504-36650495.71296.36
6368357-36835796.19696.89
60min1373333-37333397.49696.530.8798.3697.380.89
2369065-36906596.38197.21
3373472-37347297.53298.41
4365960-36596095.57096.40
5366584-36658495.73396.54
6369476-36947696.48897.35
极限1372686-37268697.32796.310.8498.3597.310.86
2368189-36818996.15297.14
3372021-37202197.15398.19
4365171-36517195.36496.35
5365858-36585895.54496.51
6368767-36876796.30397.32
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500
标示量(mg)20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%
111.193846163845333846103845753842173845100.05
211.173845413844573844990.02
单位质量响应值RSD%判断
34361.9334422.470.13数据可信
供试品溶液-BXK2XG1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%
5min1190662-19066249.85440.8119.6849.8540.8119.68
2141887-14188737.10037.10
3162905-16290542.59642.60
4138838-13883836.30336.30
5189314-18931449.50149.50
6112854-11285429.50929.51
10min1351975-35197592.03481.886.8692.1281.956.86
2307408-30740880.38080.44
3305788-30578879.95780.03
4319194-31919483.46283.52
5306332-30633280.09980.18
6288180-28818075.35375.40
15min1359483-35948393.99792.511.3194.2392.711.31
2349647-34964791.42591.62
3350052-35005291.53191.74
4358238-35823893.67193.87
5349485-34948591.38391.60
6355843-35584393.04593.22
20min1359756-35975694.06894.830.8594.4695.180.83
2363837-36383795.13595.48
3363878-36387895.14695.50
4363828-36382895.13395.49
5358204-35820493.66294.03
6366456-36645695.82096.15
30min1360678-36067894.30995.400.9794.8695.920.95
2367122-36712295.99496.50
3364534-36453495.31895.83
4364466-36446695.30095.81
5361909-36190994.63195.16
6370400-37040096.85197.34
45min1360532-36053294.27195.351.0994.9896.021.07
2367095-36709595.98796.65
3364375-36437595.27695.95
4364415-36441595.28795.96
5360587-36058794.28694.97
6370875-37087596.97697.63
60min1359521-35952194.00795.231.1694.8796.061.13
2366048-36604895.71496.54
3363699-36369995.09995.93
4365460-36546095.56096.39
5359804-35980494.08194.92
6370642-37064296.91597.73
极限1359278-35927893.94395.381.1094.9696.371.08
2365995-36599595.70096.69
3362954-36295494.90595.90
4364116-36411695.20896.20
5364767-36476795.37996.37
6371471-37147197.13298.11
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