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%
110.973769143769763765293767993768203768080.05
211.033771143769443770290.04
单位质量响应值RSD%判断
34348.9534182.140.35数据可信
供试品溶液-24122701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%
5min147525-4752512.47310.6918.2012.4710.6918.20
248418-4841812.70712.71
332782-327828.6048.60
431085-310858.1588.16
544303-4430311.62711.63
640247-4024710.56310.56
10min1143520-14352037.66634.1813.0937.6934.2013.09
2152209-15220939.94739.97
3115477-11547730.30630.32
4106946-10694628.06828.08
5135386-13538635.53235.55
6127887-12788733.56333.58
15min1240759-24075963.18658.629.4563.2758.709.45
2248087-24808765.10965.20
3204930-20493053.78353.85
4192845-19284550.61150.67
5229558-22955860.24760.33
6223952-22395258.77558.85
20min1287289-28728975.39872.333.8975.5972.503.91
2288523-28852375.72275.92
3268041-26804170.34670.50
4261094-26109468.52368.67
5274357-27435772.00472.18
6274272-27427271.98272.15
30min1319418-31941883.83081.771.9284.1482.061.94
2319099-31909983.74684.07
3307974-30797480.82781.10
4307916-30791680.81181.07
5306699-30669980.49280.79
6308362-30836280.92881.22
45min1338240-33824088.77086.691.7289.2287.121.73
2336178-33617888.22988.69
3326347-32634785.64886.05
4330222-33022286.66587.06
5325402-32540285.40085.83
6325528-32552885.43485.86
60min1347637-34763791.23689.191.6291.8489.761.63
2344753-34475390.47991.09
3335431-33543188.03388.58
4340913-34091389.47190.01
5334768-33476887.85988.43
6335473-33547388.04488.61
极限1354369-35436993.00391.051.5493.7691.781.55
2351141-35114192.15692.92
3343151-34315190.05990.75
4349110-34911091.62392.31
5342401-34240189.86290.58
6341455-34145589.61390.33
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%
110.973766623766333765723762883763493765010.05
211.033769753769933769840.01
单位质量响应值RSD%判断
34320.9734178.060.30数据可信
供试品溶液-24122701批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min127122-271227.1218.2951.747.128.2951.74
261513-6151316.15116.15
315074-150743.9583.96
434509-345099.0619.06
519895-198955.2245.22
631291-312918.2168.22
10min195929-9592925.18827.6617.0625.2027.6817.08
2135564-13556435.59535.62
395113-9511324.97424.98
4119110-11911031.27531.29
589791-8979123.57623.58
696621-9662125.37025.38
15min1153890-15389040.40741.498.2740.4641.558.29
2173227-17322745.48445.57
3154507-15450740.56940.62
4174920-17492045.92846.00
5144145-14414537.84837.90
6147328-14732838.68438.74
20min1183242-18324248.11448.505.1348.2348.635.16
2196613-19661351.62451.79
3182809-18280948.00048.12
4195049-19504951.21451.36
5172460-17246045.28345.39
6178111-17811146.76646.89
30min1217209-21720957.03257.043.5057.2357.253.52
2226551-22655159.48559.73
3215752-21575256.65056.85
4224736-22473659.00959.24
5206006-20600654.09154.28
6213160-21316055.96956.17
45min1244391-24439164.16963.952.4864.4764.262.50
2250843-25084365.86366.21
3242378-24237863.64163.93
4247631-24763165.02065.35
5233077-23307761.19961.48
6242995-24299563.80364.09
60min1260159-26015968.31067.892.0368.7168.302.06
2264439-26443969.43369.89
3257612-25761267.64168.04
4260674-26067468.44568.88
5248865-24886565.34465.72
6259531-25953168.14568.54
极限1268818-26881870.58370.231.5071.1070.751.52
2271696-27169671.33971.91
3265842-26584269.80270.31
4268786-26878670.57571.12
5260275-26027568.34068.83
6269370-26937070.72871.24
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