布瑞哌唑口服混悬液项目信息
介质体积(ml)900.取样体积(ml)10补液体积(ml)10
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%
110.878185781674821268190081848818810.20
211.078240482262823330.13
单位质量响应值RSD%判断
7532.757437.490.90数据可信
供试品溶液-25090901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%
10min1-0.0000.7261.760.000.7261.66
2535-5350.6400.64
3663-6630.7930.79
4626-6260.7490.75
51174-11741.4051.40
6637-6370.7620.76
15min1992-9921.1871.4624.851.191.4724.98
21032-10321.2351.24
31480-14801.7711.78
41407-14071.6831.69
51572-15721.8811.90
6838-8381.0031.01
20min1953-9531.1402.3527.361.152.3827.43
22001-20012.3942.41
32555-25553.0573.09
42193-21932.6242.65
52107-21072.5212.56
61988-19882.3782.40
30min1944-9441.1291.4929.641.161.5429.37
21264-12641.5121.56
31298-12981.5531.62
41307-13071.5641.62
51856-18562.2212.29
6790-7900.9450.99
45min11840-18402.2012.5830.572.242.6530.18
21896-18962.2682.33
31897-18972.2702.35
41999-19992.3922.47
53498-34984.1854.27
61817-18172.1742.23
60min13069-30693.6723.2112.933.733.3112.48
22377-23772.8442.93
32315-23152.7702.87
42422-24222.8983.00
52970-29703.5533.69
62955-29553.5353.62
极限12572-25723.0772.9512.883.183.0811.67
22493-24932.9833.10
32723-27233.2583.39
42575-25753.0813.21
51834-18342.1942.37
62583-25833.0903.21
布瑞哌唑口服混悬液项目信息
介质体积(ml)900.取样体积(ml)10补液体积(ml)10
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%
110.878242982259824688226982133823120.17
211.078212282173821480.05
单位质量响应值RSD%判断
7572.407420.781.44数据可信
供试品溶液-25090902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%
10min1361-3610.4311.4573.740.431.4573.67
2622-6220.7430.74
3708-7080.8460.85
41440-14401.7201.72
52825-28253.3753.37
61314-13141.5701.57
15min11671-16711.9962.1245.582.002.1445.10
21087-10871.2991.31
31906-19062.2772.29
42048-20482.4472.47
5833-8330.9951.03
63125-31253.7333.75
20min11398-13981.6701.6634.921.701.7033.47
22344-23442.8002.82
31073-10731.2821.32
41096-10961.3091.36
51149-11491.3731.42
61259-12591.5041.56
30min12359-23592.8182.1829.142.862.2427.92
22003-20032.3932.45
31671-16711.9962.05
42249-22492.6872.75
51793-17932.1422.21
6880-8801.0511.13
45min12168-21682.5902.2234.952.672.3133.43
21394-13941.6651.75
33019-30193.6073.68
41777-17772.1232.21
51532-15321.8301.92
61274-12741.5221.61
60min12577-25773.0792.5525.743.182.6524.75
21970-19702.3532.45
32043-20432.4412.55
42929-29293.4993.61
51904-19042.2752.38
61367-13671.6331.74
极限11850-18502.2102.7215.642.352.8615.02
22536-25363.0303.15
32242-22422.6782.82
42845-28453.3993.55
52125-21252.5392.67
62080-20802.4852.61
布瑞哌唑口服混悬液项目信息
介质体积(ml)900.取样体积(ml)10补液体积(ml)10
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%
110.878222582198819678208781799820550.22
211.078206882251821600.16
单位质量响应值RSD%判断
7548.767421.861.20数据可信
供试品溶液-25090903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%
10min13612-36124.3224.7519.704.324.7619.70
23014-30143.6063.61
34138-41384.9514.95
44338-43385.1905.19
55246-52466.2766.28
63492-34924.1784.18
15min14142-41424.9565.5631.715.005.6131.47
23043-30433.6413.68
34070-40704.8694.92
46804-68048.1418.20
53698-36984.4244.49
66105-61057.3047.35
20min13602-36024.3104.0218.934.414.1318.11
23599-35994.3064.39
33643-36434.3594.47
42987-29873.5743.72
54057-40574.8544.97
62265-22652.7102.84
30min13450-34504.1283.8519.714.284.0019.34
21958-19582.3432.47
33235-32353.8704.03
43457-34574.1364.32
53708-37084.4364.61
63481-34814.1654.32
45min13425-34254.0984.233.954.294.434.08
23434-34344.1094.26
33686-36864.4104.61
43691-36914.4164.65
53378-33784.0424.26
63594-35944.3004.50
60min13466-34664.1474.443.764.394.693.69
23774-37744.5154.72
33640-36404.3554.60
43759-37594.4974.78
53780-37804.5234.79
63857-38574.6154.87
极限12589-25893.0983.436.833.393.736.10
22991-29913.5793.83
33151-31513.7704.07
42744-27443.2833.62
52893-28933.4613.78
62819-28193.3733.68
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