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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.233849473847813849003842633843413846460.09
211.263849433846553847990.06
单位质量响应值RSD%判断
34251.6534173.980.17数据可信
高温30天-供试品溶液-24101601批-20mg-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1165488-16548843.53337.0215.2843.5337.0215.27
2129893-12989334.17034.17
3126805-12680533.35733.36
10min1125856-12585633.10827.9019.5533.1827.9619.53
284503-8450322.22922.29
3107796-10779628.35728.41
15min1252918-25291866.53361.027.9666.6661.137.97
2224917-22491759.16759.26
3218107-21810757.37557.48
20min1208193-20819354.76751.3813.4455.0151.5913.42
2165141-16514143.44243.63
3212657-21265755.94156.14
30min1283453-28345374.56571.104.4874.8971.394.49
2267704-26770470.42270.69
3259684-25968468.31268.60
45min1248039-24803965.24963.3610.6365.7063.7710.58
2212440-21244055.88456.27
3262063-26206368.93869.34
60min1298337-29833778.48076.832.1879.0477.352.19
2292222-29222276.87277.35
3285652-28565275.14475.66
极限1273093-27309371.84070.878.1072.5371.518.06
2245991-24599164.71065.31
3289127-28912776.05876.70
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.233878853879463876253872423868033875000.13
211.263876683879243877960.05
单位质量响应值RSD%判断
34505.7934440.140.14数据可信
高温30天-供试品溶液-24101601批-20mg-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min199595-9959526.00231.7415.6826.0031.7415.68
2133234-13323434.78434.78
3131937-13193734.44534.45
10min1156373-15637340.82534.9315.7640.8734.9815.72
2114639-11463929.92929.99
3130335-13033534.02734.08
15min1178725-17872546.66154.0012.3346.7754.1112.31
2228456-22845659.64459.75
3213357-21335755.70255.82
20min1257410-25741067.20360.9313.2067.3961.1313.15
2198666-19866651.86752.07
3244059-24405963.71863.92
30min1218781-21878157.11864.3210.4157.4264.6310.36
2269472-26947270.35270.65
3250861-25086165.49365.81
45min1289983-28998375.70770.979.9876.1071.389.92
2240649-24064962.82763.24
3284870-28487074.37274.79
60min1246794-24679464.43270.988.5564.9571.508.49
2292702-29270276.41776.93
3276097-27609772.08272.63
极限1297350-29735077.63075.687.2278.2676.337.17
2266258-26625869.51370.16
3306048-30604879.90180.57
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