非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.203987776398989339890353980972398506539865480.10
210.364041874404830440450890.12
单位质量响应值RSD%判断
390838.04390452.610.07数据可信
供试品溶液-4226A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%
5min1303780-3037806.9996.6823.267.006.6823.27
2172816-1728163.9813.98
3261288-2612886.0206.02
4343746-3437467.9197.92
5361159-3611598.3218.32
6298122-2981226.8686.87
10min1558781-55878112.87413.547.4112.8913.567.42
2533424-53342412.28912.30
3555831-55583112.80612.82
4626388-62638814.43114.45
5635806-63580614.64814.67
6617126-61712614.21814.23
15min1672133-67213315.48516.103.6615.5316.143.67
2673626-67362615.52015.56
3683355-68335515.74415.79
4710439-71043916.36816.42
5723184-72318416.66116.71
6729713-72971316.81216.86
20min1726496-72649616.73817.142.3416.8217.222.36
2730754-73075416.83616.91
3729970-72997016.81816.89
4747564-74756417.22317.31
5760876-76087617.53017.62
6767136-76713617.67417.76
30min1774491-77449117.84317.991.7717.9618.111.78
2775993-77599317.87817.99
3762680-76268017.57117.69
4780095-78009517.97218.10
5788425-78842518.16418.29
6803082-80308218.50218.63
45min1790936-79093618.22218.322.4918.3818.482.50
2790932-79093218.22218.37
3764072-76407217.60317.76
4795472-79547218.32718.49
5807496-80749618.60418.77
6823437-82343718.97119.14
60min1789432-78943218.18818.632.2518.3818.832.27
2805825-80582518.56518.75
3793492-79349218.28118.47
4806365-80636518.57818.78
5816546-81654618.81219.02
6839914-83991419.35119.56
极限1806050-80605018.57018.851.9018.8119.091.90
2821835-82183518.93419.16
3797421-79742118.37218.60
4816619-81661918.81419.06
5825147-82514719.01019.26
6841761-84176119.39319.64
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.204066218406811040597784061317405707640625000.12
210.364152129415207841521040.01
单位质量响应值RSD%判断
398284.31400782.240.45数据可信
供试品溶液-4226A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%
5min1381523-3815238.5946.8025.258.596.8025.26
2234788-2347885.2895.29
3183974-1839744.1444.14
4334237-3342377.5297.53
5320010-3200107.2097.21
6355471-3554718.0088.01
10min1645097-64509714.53213.806.0814.5513.826.08
2592698-59269813.35113.36
3549874-54987412.38712.40
4628138-62813814.15014.17
5611380-61138013.77213.79
6648419-64841914.60714.62
15min1721055-72105516.24316.081.7416.2916.121.77
2710770-71077016.01116.05
3690041-69004115.54415.58
4720314-72031416.22616.27
5716782-71678216.14716.19
6723420-72342016.29616.35
20min1753183-75318316.96716.930.6917.0517.010.71
2750338-75033816.90216.98
3743001-74300116.73716.81
4756475-75647517.04117.12
5750227-75022716.90016.98
6756907-75690717.05017.14
30min1781267-78126717.59917.640.4517.7217.760.48
2780668-78066817.58617.70
3778704-77870417.54117.65
4787262-78726217.73417.86
5786857-78685717.72517.85
6783089-78308917.64017.76
45min1799662-79966218.01418.070.3018.1818.230.28
2803338-80333818.09618.25
3804867-80486718.13118.28
4804599-80459918.12518.29
5800827-80082718.04018.20
6799770-79977018.01618.18
60min1802021-80202118.06718.250.6918.2718.450.66
2812410-81241018.30118.49
3815541-81554118.37118.56
4814168-81416818.34018.54
5812461-81246118.30218.50
6804404-80440418.12018.32
极限1812128-81212818.29418.400.8018.5418.640.75
2818401-81840118.43618.67
3823279-82327918.54618.77
4817710-81771018.42018.66
5822344-82234418.52518.76
6806244-80624418.16218.41
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