布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
1 11.088251082833829038300082790828070.23
210.968264882721826840.07
单位质量响应值RSD%判断
7473.567544.160.67数据可信
供试品溶液-25061901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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min14397-43975.2443.55182.425.243.55182.46
213463-1346316.05616.06
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min115550-1555018.54512.5584.0418.5712.5784.18
225853-2585330.83330.92
37785-77859.2859.28
42155-21552.5702.57
53630-36304.3294.33
68156-81569.7279.73
45min119553-1955323.31922.9327.4623.4523.0227.75
229538-2953835.22835.49
315740-1574018.77218.82
417357-1735720.70020.71
515301-1530118.24818.27
617871-1787121.31321.37
60min122478-2247826.80831.0214.6527.0731.2414.86
233442-3344239.88440.34
324628-2462829.37229.53
424581-2458129.31629.45
525844-2584430.82230.95
625095-2509529.92930.10
90min127350-2735032.61833.0410.4433.0333.4310.70
233034-3303439.39740.07
326219-2621931.26931.59
428558-2855834.05934.35
526187-2618731.23131.53
624867-2486729.65730.00
120min128934-2893434.50735.714.7735.1036.294.83
231141-3114137.13938.04
329075-2907534.67535.17
431349-3134937.38737.87
531128-3112837.12437.59
628051-2805133.45433.96
极限131247-3124737.26637.765.1238.0538.535.24
233350-3335039.77440.88
330665-3066536.57237.26
433585-3358540.05440.74
531757-3175737.87438.55
629340-2934034.99135.68
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
1 11.088271582957827118271482870827930.14
210.968276982719827440.05
单位质量响应值RSD%判断
7472.297549.640.73数据可信
供试品溶液-25061901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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0002.16244.950.002.16244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
610852-1085212.93912.94
30min112734-1273415.18315.2771.3515.1815.2871.47
218950-1895022.59422.59
38827-882710.52410.52
44893-48935.8345.83
53789-37894.5184.52
627631-2763132.94433.02
45min120576-2057624.53326.7919.0724.6226.8819.28
227849-2784933.20433.33
320123-2012323.99224.05
418744-1874422.34822.38
519477-1947723.22223.25
628024-2802433.41333.67
60min126352-2635231.41926.7952.1631.6427.0451.42
234492-3449241.12441.43
326167-2616731.19931.39
422421-2242126.73226.89
525401-2540130.28530.44
6-0.0000.44
90min125158-2515829.99633.3810.9930.3933.7711.10
232683-3268338.96839.51
327944-2794433.31733.68
425862-2586230.83531.14
525640-2564030.57030.89
630678-3067836.57737.02
120min128093-2809333.49535.014.2534.0635.594.33
231228-3122837.23337.99
330129-3012935.92236.47
428369-2836933.82434.30
529892-2989235.64036.13
628452-2845233.92334.57
极限128320-2832033.76637.296.9434.5138.077.02
234099-3409940.65641.62
332249-3224938.45039.20
429627-2962735.32435.99
530510-3051036.37737.07
632871-3287139.19240.02
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
1 11.088263482546823908239782441824820.13
210.968287982926829020.05
单位质量响应值RSD%判断
7444.227564.051.13数据可信
供试品溶液-25062301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%
10min1-0.00021.84244.950.0021.84244.95
2-0.0000.00
3-0.0000.00
4109820-109820131.061131.06
5-0.0000.00
6-0.0000.00
15min1-0.0004.40166.810.004.52160.53
215822-1582218.88218.88
32500-25002.9842.98
4-0.0000.73
5-0.0000.00
63820-38204.5594.56
30min114174-1417416.91622.4842.9416.9222.6342.08
231009-3100937.00737.11
313956-1395616.65516.67
49754-975411.64112.37
525942-2594230.96030.96
618195-1819521.71421.74
45min124776-2477629.56831.0214.4929.6631.2914.25
232584-3258438.88639.20
323153-2315327.63127.74
422829-2282927.24528.04
524339-2433929.04729.22
628266-2826633.73333.88
60min128170-2817033.61933.8010.2933.8834.2410.12
232217-3221738.44838.97
324365-2436529.07829.34
426085-2608531.13032.07
528224-2822433.68334.02
630886-3088636.86037.19
90min130224-3022436.07044.7133.1536.5145.3432.53
233828-3382840.37141.11
362608-6260874.71775.14
434593-3459341.28442.40
531637-3163737.75638.28
631907-3190738.07838.62
120min131817-3181737.97136.006.3338.6236.886.30
231509-3150937.60338.57
326702-2670231.86732.71
431024-3102437.02538.37
530636-3063636.56237.29
629321-2932134.99235.74
极限135074-3507441.85840.745.0942.7141.825.13
236255-3625543.26744.44
331258-3125837.30438.32
434650-3465041.35242.90
534479-3447941.14842.08
633125-3312539.53240.48
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
1 11.088271382635826798254282640826420.08
210.968257182405824880.15
单位质量响应值RSD%判断
7458.667526.280.64数据可信
供试品溶液-25062301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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min115417-1541718.42716.1532.9718.4316.1532.96
213810-1381016.50616.51
36668-66687.9707.97
413609-1360916.26616.27
511402-1140213.62813.63
620156-2015624.09124.09
45min129969-2996935.82030.0017.7035.9230.0917.71
222719-2271927.15427.25
317359-1735920.74820.79
427010-2701032.28332.37
526926-2692632.18332.26
626635-2663531.83531.97
60min129468-2946835.22131.5013.0735.5231.7613.09
228188-2818833.69133.93
319914-1991423.80223.96
427737-2773733.15233.42
527618-2761833.01033.26
625226-2522630.15130.46
90min134145-3414540.81137.618.5741.3138.048.60
231671-3167137.85438.28
327479-2747932.84433.14
432208-3220838.49638.95
534153-3415340.82041.26
629140-2914034.82935.31
120min132853-3285339.26736.649.7239.9937.289.71
229329-2932935.05535.69
326925-2692532.18132.66
431867-3186738.08838.76
534718-3471841.49642.16
628231-2823133.74234.41
极限140682-4068248.62441.8410.4149.5742.6810.38
233795-3379540.39341.23
330970-3097037.01637.67
438080-3808045.51446.39
533879-3387940.49341.39
632634-3263439.00539.86
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