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%
1 11.058205482006819308162881579818390.27
2 11.088163582103818690.41
单位质量响应值RSD%判断
7406.247388.900.17数据可信
供试品溶液-2810778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%
10min1830-8301.0051.9334.811.001.9334.92
21020-10201.2351.23
31579-15791.9111.91
42028-20282.4552.45
52018-20182.4432.44
62108-21082.5522.55
15min15232-52326.3347.3511.716.347.3711.77
25939-59397.1897.20
36344-63447.6807.70
46091-60917.3737.40
55546-55466.7146.74
67276-72768.8088.84
20min17221-72218.7418.782.908.828.882.83
27534-75349.1209.21
37259-72598.7878.89
46895-68958.3478.46
57259-72598.7878.89
67363-73638.9139.04
30min17004-70048.47910.0710.968.6610.2710.85
27401-74018.9599.15
38655-865510.47710.68
48573-857310.37810.58
59295-929511.25211.45
68992-899210.88511.11
45min19163-916311.09211.878.8211.3712.198.75
29435-943511.42111.72
39178-917811.11011.43
49762-976211.81712.13
59844-984411.91612.24
611475-1147513.89114.24
60min110715-1071512.97113.527.9713.3713.977.79
210543-1054312.76313.18
312883-1288315.59516.04
410926-1092613.22613.67
510601-1060112.83313.29
611367-1136713.76014.26
极限112021-1202114.55215.454.5415.0916.054.61
212239-1223914.81615.38
313022-1302215.76416.38
413064-1306415.81416.41
512652-1265215.31615.92
613588-1358816.44917.10
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%
1 11.058155381202817418173581417815300.28
2 11.088153181806816680.24
单位质量响应值RSD%判断
7378.287370.760.08数据可信
供试品溶液-2810778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%
10min1720-7200.8741.9636.140.871.9636.23
21119-11191.3591.36
32032-20322.4672.47
42154-21542.6162.62
51616-16161.9621.96
62054-20542.4942.49
15min14599-45995.5856.537.655.596.557.71
25656-56566.8686.88
35418-54186.5796.61
45313-53136.4526.48
55525-55256.7096.73
65744-57446.9757.00
20min17399-73998.9858.717.519.068.807.44
26239-62397.5767.67
37682-76829.3289.43
47207-72078.7528.85
56890-68908.3678.46
67600-76009.2299.33
30min18786-878610.66910.074.1410.8410.264.06
27889-78899.5809.76
38284-828410.05910.26
48176-81769.92810.13
58022-80229.7419.93
68599-859910.44210.65
45min110758-1075813.06412.205.7813.3512.515.55
210167-1016712.34612.63
310299-1029912.50612.82
410064-1006412.22112.53
510018-1001812.16512.46
68998-899810.92611.25
60min18893-889310.79912.999.8111.2313.439.48
212155-1215514.76015.18
310851-1085113.17713.63
410980-1098013.33313.78
510726-1072613.02513.46
610570-1057012.83513.28
极限110718-1071813.01513.898.1713.5714.487.85
211532-1153214.00414.59
311812-1181214.34414.94
49968-996812.10412.70
512221-1222114.84015.42
612396-1239615.05315.64
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