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%
110.203978406397844739808283979157398185939797390.04
210.364053705405217740529410.03
单位质量响应值RSD%判断
390170.49391210.520.19数据可信
供试品溶液-4226A批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min167745-677451.5611.3715.781.561.3715.77
250819-508191.1711.17
366425-664251.5301.53
469210-692101.5941.59
548693-486931.1221.12
653405-534051.2301.23
10min177794-777941.7921.4820.991.801.4920.90
273446-734461.6921.69
375001-750011.7281.73
457262-572621.3191.32
560137-601371.3851.39
642713-427130.9840.99
15min186594-865941.9951.8111.332.001.8211.30
284706-847061.9511.96
384394-843941.9441.95
477943-779431.7961.80
575816-758161.7471.75
662638-626381.4431.45
20min182695-826951.9051.849.701.921.859.73
284880-848801.9551.97
385672-856721.9741.99
479737-797371.8371.85
581131-811311.8691.88
664693-646931.4901.50
30min179904-799041.8411.6719.581.861.6919.53
285765-857651.9761.99
382581-825811.9021.92
456433-564331.3001.31
578181-781811.8011.81
652811-528111.2171.23
45min177632-776321.7881.6912.281.811.7012.33
282485-824851.9001.92
377931-779311.7951.82
473117-731171.6841.70
571427-714271.6451.66
656701-567011.3061.32
60min176850-768501.7701.6014.831.791.6214.85
275460-754601.7381.76
377438-774381.7841.81
469766-697661.6071.63
567293-672931.5501.57
650189-501891.1561.17
极限155770-557701.2851.259.971.311.2810.02
256102-561021.2921.32
358320-583201.3431.37
452878-528781.2181.24
559225-592251.3641.39
644322-443221.0211.04
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%
110.204010228401379740066134012104401023540105950.07
210.364148879414712441480020.03
单位质量响应值RSD%判断
393195.59400386.291.29数据可信
供试品溶液-4226A批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min160981-609811.3831.4916.011.381.4915.98
277663-776631.7621.76
374979-749791.7011.70
457347-573471.3011.30
571176-711761.6151.61
651566-515661.1701.17
10min144586-445861.0111.5121.121.011.5121.09
280582-805821.8281.83
356521-565211.2821.29
476704-767041.7401.74
576048-760481.7251.73
663737-637371.4461.45
15min164349-643491.4601.7910.771.471.7910.62
285224-852241.9331.94
375147-751471.7051.71
484933-849331.9271.93
586246-862461.9561.96
676807-768071.7421.75
20min169199-691991.5701.827.351.581.837.31
281254-812541.8431.86
385603-856031.9421.95
484580-845801.9191.93
581700-817001.8531.87
679235-792351.7971.81
30min153489-534891.2131.6420.541.231.6620.29
287052-870521.9751.99
353498-534981.2141.23
481288-812881.8441.86
579705-797051.8081.82
678674-786741.7851.80
45min159513-595131.3501.7211.831.361.7411.99
278801-788011.7881.81
377974-779741.7691.79
485380-853801.9371.96
580917-809171.8361.86
673285-732851.6621.68
60min149411-494111.1211.6516.491.141.6716.39
274247-742471.6841.71
375136-751361.7041.73
483531-835311.8951.92
579617-796171.8061.83
674315-743151.6861.71
极限145774-457741.0381.3112.811.061.3412.64
264080-640801.4541.48
353389-533891.2111.24
458025-580251.3161.34
565844-658441.4941.52
660098-600981.3631.39
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