非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.124073454082274089434083304079064081500.15
211.184061574067894064730.11
单位质量响应值RSD%判断
36704.1436357.160.68数据可信
供试品溶液-BJ84960批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113105-1310516.12813.8618.1916.1313.8618.19
27936-79369.7669.77
39891-989112.17212.17
411281-1128113.88313.88
513238-1323816.29116.29
612116-1211614.91014.91
10min129305-2930536.06433.9312.0636.2434.0812.08
221324-2132426.24226.35
326276-2627632.33632.47
429090-2909035.79935.95
529915-2991536.81537.00
629495-2949536.29836.46
15min138006-3800646.77244.819.3947.3545.349.44
229725-2972536.58136.98
336158-3615844.49744.99
437303-3730345.90746.46
539053-3905348.06048.65
638223-3822347.03947.61
20min144457-4445754.71053.988.9055.8155.018.94
236610-3661045.05445.86
342968-4296852.87853.87
445262-4526255.70156.76
546120-4612056.75757.88
647785-4778558.80659.90
30min153067-5306765.30667.027.6767.0168.657.72
247757-4775758.77260.08
352335-5233564.40565.98
457145-5714570.32572.01
557828-5782871.16572.92
658618-5861872.13873.88
45min164222-6422279.03480.458.5281.4782.838.52
256954-5695470.09072.05
361137-6113775.23877.53
470796-7079687.12489.59
569327-6932785.31687.86
669815-6981585.91788.46
60min168346-6834684.10988.447.1287.4291.717.16
263825-6382578.54581.28
371080-7108087.47490.60
475985-7598593.51096.94
574922-7492292.20295.70
677053-7705394.82498.33
90min171568-7156888.07490.721.9892.3294.972.13
272229-7222988.88892.50
374921-7492192.20196.30
474362-7436291.51395.98
574187-7418791.29795.82
675026-7502692.33096.88
120min173700-7370090.69895.423.3195.92100.683.39
274927-7492792.20896.81
378716-7871696.871102.00
478698-7869896.849102.34
579685-7968598.063103.60
679512-7951297.851103.43
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限177879-7787995.84196.361.39102.07102.681.24
278769-7876996.936102.56
379487-7948797.820104.02
476355-7635593.965100.53
578824-7882497.004103.63
678478-7847896.578103.25
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