比拉斯汀口腔崩解片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.063842413838133834633837353836093837720.08
211.073840113842243841180.04
单位质量响应值RSD%判断
34699.1034699.010.01数据可信
供试品溶液-4A84A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1380367-38036798.26297.003.3098.2697.003.29
2387238-387238100.037100.04
3376997-37699797.39297.39
4382714-38271498.86998.87
5373347-37334796.44996.45
6352198-35219890.98590.99
10min1384790-38479099.40599.670.8799.5799.830.87
2390706-390706100.933101.10
3380715-38071598.35298.51
4387615-387615100.135100.30
5386374-38637499.81499.97
6384621-38462199.36199.51
15min1384834-38483499.41699.520.9799.7599.850.97
2390137-390137100.786101.12
3379215-37921597.96598.29
4387535-387535100.114100.45
5385903-38590399.692100.02
6383720-38372099.12999.45
20min1383447-38344799.05899.370.9799.5599.860.97
2389651-389651100.661101.16
3379139-37913997.94598.43
4387454-387454100.093100.59
5385337-38533799.546100.04
6382895-38289598.91599.40
30min1382644-38264498.85199.231.0399.5199.891.03
2389259-389259100.559101.23
3378300-37830097.72898.38
4387603-387603100.132100.80
5384542-38454299.341100.00
6382350-38235098.77599.42
极限1381533-38153398.56499.071.0299.3999.891.02
2388431-388431100.346101.18
3377984-37798497.64798.46
4387385-387385100.075100.91
5383624-38362499.10499.93
6381953-38195398.67299.48
比拉斯汀口腔崩解片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.063843083844393843143845323841893843560.04
211.073844553846333845440.04
单位质量响应值RSD%判断
34751.9034737.490.03数据可信
供试品溶液-4A84A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1366017-36601794.43197.692.2994.4397.682.29
2382612-38261298.71298.71
3369243-36924395.26395.26
4383671-38367198.98698.99
5384129-38412999.10499.10
6386118-38611899.61799.62
10min1381457-38145798.41499.770.8298.5799.940.82
2385341-38534199.41799.58
3389300-389300100.438100.60
4387458-38745899.963100.13
5386532-38653299.72499.89
6390276-390276100.690100.86
15min1381224-38122498.35499.590.7198.6899.920.71
2384737-38473799.26199.59
3388218-388218100.159100.48
4386765-38676599.784100.12
5386286-38628699.66099.99
6388742-388742100.294100.63
20min1380322-38032298.12299.450.8098.6199.940.80
2383819-38381999.02499.52
3388200-388200100.154100.65
4386021-38602199.592100.09
5385743-38574399.520100.02
6388659-388659100.273100.77
30min1379524-37952497.91699.200.8298.5699.860.83
2383068-38306898.83099.49
3387070-38707099.863100.52
4384183-38418399.11899.78
5384757-38475799.26699.93
6388498-388498100.231100.90
极限1379571-37957197.92899.120.7798.7499.940.77
2382351-38235198.64599.47
3387129-38712999.878100.70
4384755-38475599.265100.09
5384038-38403899.08099.91
6387241-38724199.907100.74
比拉斯汀口腔崩解片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.063851833846373843753838233836303843300.17
211.073851603852663852130.02
单位质量响应值RSD%判断
34749.5534797.920.10数据可信
供试品溶液-2024121921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1391792-391792100.996101.001.46101.00101.001.46
2394433-394433101.677101.68
3400547-400547103.253103.25
4389193-389193100.327100.33
5383286-38328698.80498.80
6391553-391553100.935100.93
10min1394679-394679101.741101.761.39101.91101.931.39
2393048-393048101.320101.49
3404385-404385104.243104.41
4392636-392636101.214101.38
5387828-38782899.975100.14
6395948-395948102.068102.24
15min1393709-393709101.491101.501.38101.83101.841.38
2392473-392473101.172101.51
3403629-403629104.048104.39
4391535-391535100.930101.27
5387245-38724599.824100.16
6393941-393941101.550101.89
20min1392866-392866101.273101.401.38101.78101.911.38
2392500-392500101.179101.69
3403084-403084103.907104.43
4391262-391262100.860101.36
5386623-38662399.664100.16
6393814-393814101.518102.03
30min1392587-392587101.201101.251.35101.88101.921.35
2392007-392007101.052101.73
3401975-401975103.621104.31
4390946-390946100.778101.45
5385647-38564799.412100.08
6393403-393403101.412102.09
极限1390906-390906100.768101.011.47101.61101.851.47
2390573-390573100.682101.53
3402070-402070103.646104.51
4389992-389992100.532101.37
5384491-38449199.11499.94
6392940-392940101.292102.14
比拉斯汀口腔崩解片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.063860993853453856373858133853833856550.09
211.073844773843933844350.02
单位质量响应值RSD%判断
34869.3534727.640.29数据可信
供试品溶液-2024121921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1387212-38721299.745100.730.6899.75100.740.68
2392305-392305101.057101.06
3388154-38815499.98899.99
4392761-392761101.175101.17
5392378-392378101.076101.08
6393487-393487101.362101.36
10min1389067-389067100.223101.470.80100.39101.640.79
2393829-393829101.450101.62
3391509-391509100.852101.02
4396323-396323102.092102.26
5395580-395580101.901102.07
6397175-397175102.312102.48
15min1387995-38799599.947101.270.87100.28101.610.87
2393262-393262101.304101.64
3390090-390090100.487100.82
4396163-396163102.051102.39
5395158-395158101.792102.13
6396131-396131102.043102.38
20min1386465-38646599.553101.010.90100.05101.510.90
2392442-392442101.092101.60
3389421-389421100.314100.82
4395219-395219101.808102.32
5394095-394095101.518102.03
6394992-394992101.749102.26
30min1386131-38613199.467100.960.91100.13101.630.91
2392623-392623101.139101.81
3389222-389222100.263100.93
4394617-394617101.653102.33
5393866-393866101.459102.14
6395091-395091101.775102.45
极限1386326-38632699.517100.830.87100.35101.680.87
2390975-390975100.715101.56
3388716-388716100.133100.97
4394379-394379101.591102.44
5393572-393572101.384102.23
6394625-394625101.655102.50
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