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%
111.091881871877541876021877401875671877700.14
211.071859711859091859400.03
单位质量响应值RSD%判断
16931.4716796.750.57数据可信
供试品溶液-BXK34K1批-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%
5min149581-4958126.46122.8322.0026.4622.8322.00
256241-5624130.01530.02
344566-4456623.78423.78
436666-3666619.56819.57
529960-2996015.98915.99
639622-3962221.14621.15
10min1102455-10245554.67957.778.8654.7257.818.87
2124021-12402166.18866.24
3114090-11409060.88860.93
4106481-10648156.82756.86
596671-9667151.59251.62
6105751-10575156.43856.47
15min1128930-12893068.80872.525.6368.9472.665.64
2147709-14770978.83078.99
3140233-14023374.84074.98
4133571-13357171.28571.41
5127154-12715467.86067.97
6137750-13775073.51573.64
20min1143977-14397776.83980.143.9177.0980.393.92
2159339-15933985.03785.33
3151844-15184481.03781.30
4147664-14766478.80679.05
5144695-14469577.22277.45
6153420-15342081.87882.13
30min1161354-16135486.11286.932.3786.4987.322.39
2169359-16935990.38590.82
3161778-16177886.33986.74
4160622-16062285.72286.10
5158744-15874484.71985.07
6165465-16546588.30688.69
45min1170677-17067791.08890.081.8391.6190.621.84
2172457-17245792.03892.62
3167293-16729389.28289.83
4165559-16555988.35788.88
5165450-16545088.29888.79
6171326-17132691.43491.97
60min1173572-17357292.63390.971.8193.3191.651.82
2173564-17356492.62993.37
3168375-16837589.85990.55
4167564-16756489.42790.09
5167137-16713789.19989.84
6172499-17249992.06092.75
极限1182713-18271397.51196.530.9798.3497.360.99
2182023-18202397.14398.04
3181354-18135496.78697.63
4179322-17932295.70296.52
5178178-17817895.09195.88
6181625-18162596.93197.77
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%
111.091853751855751857371856811854751855690.08
211.071846911848481847700.07
单位质量响应值RSD%判断
16733.0016691.060.18数据可信
供试品溶液-BXK3152批-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%
5min123297-2329712.54619.3229.7912.5519.3229.79
243268-4326823.30123.30
344176-4417623.79023.79
421063-2106311.34311.34
542524-4252422.90122.90
640928-4092822.04122.04
10min176787-7678741.35251.2415.0241.3751.2715.03
2109779-10977959.12059.16
3102381-10238155.13655.18
477480-7748041.72641.74
5103711-10371155.85255.89
6100701-10070154.23154.27
15min1116999-11699963.00869.056.5263.1069.166.54
2136088-13608873.28873.43
3133997-13399772.16272.29
4118481-11848163.80663.89
5133615-13361571.95672.09
6130091-13009170.05970.19
20min1136059-13605973.27378.034.1873.4778.264.20
2149495-14949580.50880.77
3150188-15018880.88281.13
4138790-13879074.74374.94
5149050-14905080.26980.52
6145754-14575478.49478.74
30min1151446-15144681.55986.193.2781.8886.553.29
2161500-16150086.97387.37
3167016-16701689.94490.33
4157515-15751584.82785.15
5162450-16245087.48587.87
6160299-16029986.32786.70
45min1159165-15916585.71690.222.8786.1790.722.89
2168278-16827890.62491.16
3174195-17419593.81094.35
4167889-16788990.41490.87
5167942-16794290.44390.97
6167655-16765590.28890.81
60min1162088-16208887.29091.562.6187.8992.222.62
2170875-17087592.02292.71
3175831-17583194.69195.38
4170498-17049891.81992.43
5170389-17038991.76092.44
6170474-17047491.80692.48
极限1183203-18320398.66198.930.2799.4099.740.27
2183835-18383599.00299.84
3183984-18398499.08299.93
4184237-18423799.21899.98
5183003-18300398.55499.39
6183928-18392899.05299.87
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