非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.972702382693772697102692472689372695020.19
211.172729752731432730590.05
单位质量响应值RSD%判断
24567.1824445.750.36数据可信
供试品溶液-3788B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%
5min127977-2797710.2649.2918.5410.269.2918.54
217445-174456.4006.40
323713-237138.7008.70
431374-3137411.51111.51
526573-265739.7499.75
624819-248199.1069.11
10min153024-5302419.45418.567.1919.4718.587.19
243952-4395216.12516.14
351682-5168218.96118.98
454411-5441119.96319.98
550352-5035218.47318.49
650096-5009618.37918.39
15min165702-6570224.10524.016.3624.1524.066.35
260488-6048822.19222.23
364798-6479823.77323.82
465941-6594124.19324.25
572841-7284126.72426.77
662921-6292123.08523.13
20min174572-7457227.35926.462.3227.4526.552.34
269911-6991125.64925.72
372578-7257826.62826.71
473216-7321626.86226.95
571548-7154826.25026.34
670957-7095726.03326.12
30min182459-8245930.25329.821.2230.3929.951.24
280400-8040029.49829.61
381391-8139129.86129.99
482477-8247730.26030.40
580677-8067729.59929.73
680335-8033529.47429.60
45min188553-8855332.48932.280.9332.6732.460.94
286732-8673231.82131.99
388796-8879632.57832.76
487833-8783332.22532.41
588622-8862232.51432.70
687383-8738332.06032.24
60min191990-9199033.75033.764.3333.9933.994.31
287645-8764532.15632.38
388334-8833432.40832.64
493586-9358634.33534.58
598657-9865736.19636.43
691837-9183733.69433.92
90min196718-9671835.48435.704.1435.7835.994.11
299965-9996536.67636.95
391127-9112733.43333.72
4100962-10096237.04137.34
5100838-10083836.99637.30
694245-9424534.57734.86
120min198018-9801835.96136.9211.2336.3237.2711.10
2123189-12318945.19645.53
396773-9677335.50535.85
491813-9181333.68534.05
598053-9805335.97436.34
695861-9586135.17035.51
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198785-9878536.24335.941.4336.6636.361.42
2100077-10007736.71737.13
398090-9809035.98836.39
496280-9628035.32435.74
597924-9792435.92736.35
696643-9664335.45735.86
非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
110.975422855429085421755429265425675425720.07
211.175467845474605471220.09
单位质量响应值RSD%判断
49459.6248981.380.69数据可信
供试品溶液-4229B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%
5min141151-411517.5176.0618.397.526.0618.39
229392-293925.3695.37
334591-345916.3196.32
437084-370846.7746.77
523636-236364.3184.32
633256-332566.0756.07
10min177664-7766414.18712.717.0314.2012.727.03
268792-6879212.56612.58
366268-6626812.10512.12
471082-7108212.98513.00
563299-6329911.56311.57
670382-7038212.85712.87
15min186078-8607815.72415.184.7415.7615.224.74
284607-8460715.45515.49
375655-7565513.82013.85
485325-8532515.58615.62
581864-8186414.95414.98
685181-8518115.56015.59
20min190805-9080516.58816.194.9016.6516.254.89
290775-9077516.58216.64
380111-8011114.63414.69
492083-9208316.82116.88
588950-8895016.24916.30
689157-8915716.28616.34
30min195086-9508617.37017.034.8817.4617.124.88
295294-9529417.40817.49
384265-8426515.39315.47
496941-9694117.70817.80
594313-9431317.22817.31
693608-9360817.10017.18
45min198158-9815817.93117.049.9818.0517.159.94
298388-9838817.97318.09
375047-7504713.70913.81
499943-9994318.25718.37
595620-9562017.46717.57
692590-9259016.91417.03
60min1101773-10177318.59117.528.4918.7417.668.47
295845-9584517.50817.65
380074-8007414.62714.75
4101470-10147018.53618.68
599771-9977118.22518.36
696687-9668717.66217.80
90min1101868-10186818.60817.727.4918.7917.897.46
2102985-10298518.81218.98
385150-8515015.55515.71
4101044-10104418.45818.64
590831-9083116.59216.76
6100000-10000018.26718.44
120min196628-9662817.65117.497.7917.8617.697.76
2101424-10142418.52718.73
380969-8096914.79114.97
4100009-10000918.26918.48
597941-9794117.89118.09
697550-9755017.82018.02
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1105113-10511319.20117.559.4519.4417.779.39
299398-9939818.15718.39
380187-8018714.64814.85
491111-9111116.64316.88
5102146-10214618.65918.88
698383-9838317.97218.20
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