布瑞哌唑口服混悬液项目信息
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5000
标示量(mg)2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%
110.969301293109929429312692787929950.15
210.909263692719926780.07
单位质量响应值RSD%判断
8484.958502.570.15数据可信
供试品溶液-25060901批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min158179-5817961.33861.251.9461.3461.251.94
259792-5979263.03963.04
358688-5868861.87561.88
458005-5800561.15561.15
557436-5743660.55560.56
656477-5647759.54459.54
15min163893-6389367.36368.452.8167.4668.552.80
264808-6480868.32768.43
367602-6760271.27371.38
465357-6535768.90669.01
565684-6568469.25169.35
662182-6218265.55965.66
30min167820-6782071.50373.752.0971.7273.962.09
271141-7114175.00475.22
371493-7149375.37575.60
468634-6863472.36172.58
570718-7071874.55874.77
669885-6988573.68073.89
45min171279-7127975.15077.602.1875.4877.942.18
275399-7539979.49479.84
375050-7505079.12679.47
472399-7239976.33176.67
574287-7428778.32178.66
673211-7321177.18777.52
60min177383-7738381.58583.102.3282.0483.572.31
280399-8039984.76585.24
379797-7979784.13084.61
476302-7630280.44680.91
580896-8089685.28985.76
678153-7815382.39782.86
90min178732-7873283.00885.811.7383.6086.421.73
281858-8185886.30386.92
381974-8197486.42687.05
480961-8096185.35885.96
582359-8235986.83187.44
682467-8246786.94587.54
120min181437-8143785.85986.932.5286.5987.682.51
284724-8472489.32590.09
384305-8430588.88389.65
479103-7910383.39984.14
583140-8314087.65588.41
682012-8201286.46687.21
极限1-0.0000.00-0.880.901.55
2-0.0000.91
3-0.0000.91
4-0.0000.88
5-0.0000.90
6-0.0000.89
布瑞哌唑口服混悬液项目信息
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5000
标示量(mg)2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%
110.969336393117930139339893353932490.19
210.909346293148933050.24
单位质量响应值RSD%判断
8508.128560.090.44数据可信
供试品溶液-25060901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%
10min142004-4200444.07645.583.8544.0845.583.84
245872-4587248.13548.13
342372-4237244.46244.46
444802-4480247.01247.01
543793-4379345.95345.95
641759-4175943.81943.82
15min146739-4673949.04549.572.5449.1249.652.54
246209-4620948.48848.57
348023-4802350.39250.47
449319-4931951.75251.83
546679-4667948.98249.06
646469-4646948.76148.83
30min151845-5184554.40256.122.1854.5656.282.18
253250-5325055.87756.04
354852-5485257.55857.72
454669-5466957.36657.53
553655-5365556.30256.46
652640-5264055.23755.39
45min158813-5881361.71461.692.1561.9661.942.14
258408-5840861.28961.54
359477-5947762.41162.66
460848-6084863.85064.11
557950-5795060.80961.06
657256-5725660.08060.33
60min162593-6259365.68165.152.1166.0365.502.10
262038-6203865.09865.45
362815-6281565.91466.27
463670-6367066.81167.18
561513-6151364.54764.90
659877-5987762.83163.18
90min165997-6599769.25368.862.3369.7169.322.33
266132-6613269.39469.86
366478-6647869.75770.23
467481-6748170.81071.29
564374-6437467.54968.01
663272-6327266.39366.84
120min169420-6942072.84471.972.1473.4272.552.13
269205-6920572.61973.20
369546-6954672.97773.56
469896-6989673.34473.94
566964-6696470.26770.84
666495-6649569.77570.34
极限170576-7057674.05773.102.5274.7573.802.51
270898-7089874.39575.10
370533-7053374.01274.72
471050-7105074.55575.27
568089-6808971.44872.14
666861-6686170.15970.84
布瑞哌唑口服混悬液项目信息
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5000
标示量(mg)2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%
110.969263392530923899235592504924820.13
210.909337593369933720.01
单位质量响应值RSD%判断
8438.148566.241.07数据可信
供试品溶液-25060901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
15min12946-29463.1033.2644.933.103.2644.89
24380-43804.6144.61
34653-46534.9014.90
41706-17061.7971.80
51263-12631.3301.33
63622-36223.8153.82
30min110248-1024810.79410.4720.2010.8010.4820.23
29301-93019.7979.80
311467-1146712.07812.09
410793-1079311.36811.37
56230-62306.5626.56
611623-1162312.24312.25
45min113327-1332714.03813.876.7514.0613.896.78
212833-1283313.51713.54
314063-1406314.81314.84
413923-1392314.66514.69
511611-1161112.23012.24
613256-1325613.96313.99
60min115436-1543616.25915.576.6916.3115.626.70
213904-1390414.64514.69
314879-1487915.67215.73
415113-1511315.91915.97
513353-1335314.06514.10
616018-1601816.87216.92
90min116824-1682417.72117.327.0317.7917.397.03
217003-1700317.91017.98
318078-1807819.04219.12
415698-1569816.53516.61
514718-1471815.50315.56
616348-1634817.22017.30
120min117251-1725118.17118.424.8918.2718.524.91
217696-1769618.64018.74
318152-1815219.12019.23
417676-1767618.61818.72
515912-1591216.76016.84
618253-1825319.22619.33
极限117023-1702317.93118.6310.7118.0618.7610.69
217893-1789318.84718.98
318994-1899420.00720.15
417779-1777918.72718.86
514456-1445615.22715.34
619988-1998821.05421.19
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