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%
110.878360184031834698356983439836220.29
211.078372483854837890.11
单位质量响应值RSD%判断
7692.927569.021.15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%
10min1-0.0000.5079.290.000.5079.29
2564-5640.6620.66
3-0.0000.00
4766-7660.8990.90
5576-5760.6760.68
6640-6400.7510.75
15min11150-11501.3501.3128.901.351.3129.14
21301-13011.5271.53
3786-7860.9220.92
41598-15981.8751.89
5738-7380.8660.87
61121-11211.3161.32
20min12121-21212.4892.3933.262.502.4133.24
22185-21852.5642.59
3896-8961.0521.06
42803-28033.2903.32
51677-16771.9681.99
62532-25322.9722.99
30min11342-13421.5751.4132.771.621.4632.52
21192-11921.3991.45
3945-9451.1091.13
41866-18662.1902.26
5705-7050.8270.87
61163-11631.3651.42
45min11670-16701.9602.4734.262.022.5334.12
21887-18872.2152.28
31753-17532.0572.09
43533-35334.1464.24
51656-16561.9431.99
62137-21372.5082.58
60min12570-25703.0163.269.863.103.359.72
22545-25452.9873.08
33186-31863.7393.80
43057-30573.5883.73
52705-27053.1753.24
62612-26123.0653.16
极限12740-27403.2163.2215.853.333.3414.50
22752-27523.2303.36
33369-33693.9544.05
42013-20132.3622.54
52700-27003.1693.27
62862-28623.3593.49
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%
110.878367283878837778364883761837470.11
211.078373683796837660.06
单位质量响应值RSD%判断
7704.427566.941.28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%
10min1716-7160.8400.9470.800.840.9470.73
2644-6440.7550.76
31489-14891.7461.75
4535-5350.6270.63
51429-14291.6761.68
6-0.0000.00
15min11124-11241.3181.8838.491.331.8938.38
21959-19592.2982.31
32563-25633.0063.03
41686-16861.9771.98
5836-8360.9811.00
61440-14401.6891.69
20min12193-21932.5721.5536.442.601.5835.32
2984-9841.1541.19
3814-8140.9551.01
41437-14371.6851.71
51324-13241.5531.58
61187-11871.3921.41
30min12167-21672.5422.3334.862.592.3834.20
22078-20782.4372.48
32413-24132.8302.89
42773-27733.2523.30
5766-7660.8980.95
61727-17272.0262.06
45min11368-13681.6042.2130.891.692.2929.98
22943-29433.4523.53
31773-17732.0802.17
41982-19822.3252.41
51350-13501.5831.64
61899-18992.2272.28
60min12117-21172.4832.5825.192.582.6824.94
22201-22012.5822.69
32952-29523.4623.58
42631-26313.0863.20
51346-13461.5791.65
61971-19712.3122.39
极限12525-25252.9622.7912.323.092.9212.32
22467-24672.8933.03
32838-28383.3293.49
42025-20252.3752.52
52134-21342.5032.59
62306-23062.7052.81
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%
110.878372883702835688356583534836190.11
211.078380683769837880.04
单位质量响应值RSD%判断
7692.647568.931.15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%
10min14412-44125.1785.1319.655.185.1319.69
25249-52496.1606.16
34759-47595.5855.59
44084-40844.7934.79
54905-49055.7575.76
62822-28223.3123.31
15min14092-40924.8023.9921.364.864.0521.18
23128-31283.6713.74
33845-38454.5134.57
43992-39924.6854.74
53165-31653.7143.78
62183-21832.5622.60
20min13003-30033.5243.7913.163.643.9012.61
23853-38534.5224.63
32639-26393.0973.21
43094-30943.6313.74
53272-32723.8403.95
63537-35374.1514.22
30min13595-35954.2194.0412.444.374.1812.17
23672-36724.3104.47
33986-39864.6784.82
43535-35354.1494.29
52828-28283.3193.47
63044-30443.5723.68
45min14201-42014.9304.6054.405.134.7952.38
27788-77889.1409.35
32061-20612.4192.62
43411-34114.0034.19
51938-19382.2742.46
64118-41184.8334.98
60min13492-34924.0984.4913.464.354.7312.83
24253-42534.9915.30
34200-42004.9295.15
42939-29393.4493.69
53959-39594.6464.86
64121-41214.8365.04
极限13894-38944.5704.985.944.875.275.64
24312-43125.0615.42
34278-42785.0215.30
44457-44575.2315.51
54522-45225.3075.57
63987-39874.6794.94
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