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%
111.038242682425820808202581983821880.27
211.028180781799818030.01
单位质量响应值RSD%判断
7451.317423.140.27数据可信
供试品溶液-2821374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%
10min11963-19632.3642.4917.532.362.4817.57
21720-17202.0712.07
31855-18552.2342.23
42044-20442.4612.46
52045-20452.4622.46
62758-27583.3213.32
15min15038-50386.0666.364.786.086.384.79
25173-51736.2296.24
35090-50906.1296.14
45678-56786.8376.85
55226-52266.2936.31
65505-55056.6286.65
30min17606-76069.1589.532.629.219.582.62
27969-79699.5959.64
37757-77579.3409.39
48200-82009.8739.93
57955-79559.5789.63
68003-80039.6369.69
45min19837-983711.84511.861.6911.9411.961.70
29621-962111.58411.68
310090-1009012.14912.25
49974-997412.01012.12
59740-974011.72811.83
69848-984811.85811.97
60min111288-1128813.59213.762.4613.7613.932.42
211603-1160313.97114.13
311259-1125913.55713.72
411687-1168714.07214.25
511720-1172014.11214.28
611025-1102513.27513.45
90min112446-1244614.98615.662.3715.2315.912.35
213055-1305515.71915.96
312877-1287715.50515.75
413175-1317515.86416.12
513274-1327415.98316.23
613204-1320415.89916.15
120min113086-1308615.75717.074.3916.0817.404.34
214305-1430517.22417.55
313988-1398816.84317.17
414753-1475317.76418.10
514777-1477717.79318.13
614149-1414917.03717.37
极限114089-1408916.96417.204.6517.3717.634.56
214696-1469617.69518.12
313761-1376116.56916.99
414808-1480817.83018.27
515035-1503518.10318.54
613343-1334316.06616.50
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%
111.038357683897827298358283816835200.56
211.028332183455833880.12
单位质量响应值RSD%判断
7572.087566.970.05数据可信
供试品溶液-25082601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
15min1358-3580.4240.4657.960.420.4658.03
2410-4100.4850.49
3401-4010.4740.47
4449-4490.5310.53
5694-6940.8210.82
6-0.0000.00
30min1512-5120.6060.7716.840.610.7816.84
2801-8010.9480.95
3713-7130.8440.85
4654-6540.7740.78
5705-7050.8340.84
6541-5410.6400.64
45min1588-5880.6962.37145.860.702.38145.51
2883-8831.0451.05
37971-79719.4309.44
4982-9821.1621.17
5903-9031.0681.08
6708-7080.8380.84
60min1871-8711.0301.2811.851.041.3012.32
21088-10881.2871.30
31130-11301.3371.40
41130-11301.3371.35
51251-12511.4801.50
61018-10181.2041.21
90min11693-16932.0032.008.172.022.037.90
21715-17152.0292.05
31659-16591.9632.03
41441-14411.7051.73
51834-18342.1702.19
61794-17942.1222.14
120min11637-16371.9372.3113.911.962.3414.38
21875-18752.2182.25
32397-23972.8362.91
42123-21232.5122.54
51765-17652.0882.12
61917-19172.2682.29
极限12174-21742.5722.4016.892.612.4516.99
21796-17962.1252.17
32302-23022.7232.82
42453-24532.9022.95
51925-19252.2772.32
61532-15321.8121.85
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