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%
111.063844853849963840213843343843373844350.10
211.073842243842743842490.01
单位质量响应值RSD%判断
34759.0434710.840.10数据可信
供试品溶液-2024121821批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1261775-26177567.55664.832.5867.5664.832.58
2254575-25457565.69865.70
3244233-24423363.02963.03
4246262-24626263.55363.55
5252567-25256765.18065.18
6247919-24791963.98063.98
10min1346397-34639789.39487.591.2489.5187.701.24
2337643-33764387.13587.24
3335963-33596386.70286.81
4342618-34261888.41988.52
5335959-33595986.70186.81
6337918-33791887.20687.31
15min1373795-37379596.46595.690.8296.7395.940.82
2368496-36849695.09795.35
3368947-36894795.21495.46
4375000-37500096.77697.03
5367628-36762894.87395.13
6370799-37079995.69295.94
20min1380813-38081398.27698.170.3798.7098.580.38
2382587-38258798.73499.15
3378606-37860697.70698.11
4379282-37928297.88198.30
5380090-38009098.08998.50
6380983-38098398.32098.73
30min1386377-38637799.71299.510.68100.30100.090.68
2386738-38673899.805100.38
3382430-38243098.69399.26
4389707-389707100.571101.15
5383409-38340998.94699.52
6384992-38499299.35499.93
极限1387673-387673100.04699.760.73100.80100.510.73
2385093-38509399.380100.12
3382598-38259898.73799.47
4391055-391055100.919101.66
5386327-38632799.699100.44
6386748-38674899.808100.55
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%
111.063846173846963840833842383836633842590.11
211.073847763846283847020.03
单位质量响应值RSD%判断
34743.1334751.760.02数据可信
供试品溶液-2024121821批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1246135-24613563.49762.653.4863.5062.653.48
2250771-25077164.69364.69
3242680-24268062.60662.61
4228656-22865658.98858.99
5250591-25059164.64664.65
6238168-23816861.44261.44
10min1294755-29475576.04084.975.5476.1585.085.53
2345825-34582589.21489.32
3334011-33401186.16786.27
4325644-32564484.00884.11
5340016-34001687.71687.82
6336007-33600786.68286.78
15min1371628-37162895.87195.561.2296.1095.811.22
2375622-37562296.90197.16
3371274-37127495.78096.03
4363411-36341193.75193.99
5373690-37369096.40396.66
6366896-36689694.65094.90
20min1379242-37924297.83598.241.4698.2398.651.46
2387832-387832100.051100.47
3378817-37881797.72698.13
4373769-37376996.42396.82
5387144-38714499.874100.29
6378090-37809097.53897.94
30min1388695-388695100.27499.811.52100.83100.381.52
2394233-394233101.703102.29
3387844-387844100.054100.62
4378883-37888397.74398.30
5390720-390720100.796101.38
6380946-38094698.27598.84
极限1386934-38693499.82099.771.36100.54100.501.37
2394255-394255101.708102.46
3387343-38734399.925100.66
4380855-38085598.25198.97
5390177-390177100.656101.41
6380838-38083898.24798.98
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%
111.063849103847593847173846593848263847740.03
211.073837663837673837660.01
单位质量响应值RSD%判断
34789.6934667.210.25数据可信
供试品溶液-2024121921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1250997-25099764.78764.831.3864.7964.831.38
2257436-25743666.44966.45
3247415-24741563.86263.86
4251870-25187065.01265.01
5250434-25043464.64164.64
6248910-24891064.24864.25
10min1341225-34122588.07687.001.0588.1887.111.05
2338489-33848987.37087.48
3333199-33319986.00586.11
4338881-33888187.47187.58
5338237-33823787.30587.41
6332287-33228785.76985.88
15min1372327-37232796.10495.250.6296.3695.500.62
2369252-36925295.31095.57
3365856-36585694.43494.68
4369974-36997495.49795.75
5369498-36949895.37495.63
6367176-36717694.77595.02
20min1382639-38263998.76697.940.6699.1898.350.66
2378346-37834697.65898.07
3376407-37640797.15797.56
4382105-38210598.62899.04
5379480-37948097.95198.36
6377643-37764397.47697.88
30min1384881-38488199.34599.170.5899.9299.750.58
2383674-38367499.03399.61
3380125-38012598.11798.69
4385292-38529299.451100.03
5386515-38651599.766100.34
6384809-38480999.32699.90
极限1387515-387515100.02499.390.85100.77100.130.84
2380850-38085098.30499.05
3381215-38121598.39899.13
4385342-38534299.464100.21
5387523-387523100.027100.77
6387871-387871100.116100.85
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%
111.063846783861523857693850733851433853630.16
211.073850913837953844430.24
单位质量响应值RSD%判断
34842.9534728.360.24数据可信
供试品溶液-2024121921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1263933-26393368.01468.711.4068.0168.711.40
2271943-27194370.07870.08
3261839-26183967.47467.47
4269781-26978169.52169.52
5266507-26650768.67768.68
6265802-26580268.49568.50
10min1344518-34451888.78090.251.3388.8990.361.33
2354033-35403391.23291.35
3345005-34500588.90589.02
4355496-35549691.60991.72
5352404-35240490.81290.93
6349779-34977990.13690.25
15min1370816-37081695.55797.101.4595.8297.361.45
2380134-38013497.95898.23
3369590-36959095.24195.50
4383427-38342798.80799.08
5377616-37761697.30997.57
6379162-37916297.70797.97
20min1377266-37726697.21999.291.5997.6499.721.59
2390878-390878100.727101.16
3378481-37848197.53297.95
4391660-391660100.928101.36
5386669-38666999.642100.07
6386919-38691999.706100.13
30min1383600-38360098.85199.991.0399.43100.581.03
2392489-392489101.142101.74
3382722-38272298.62599.21
4390744-390744100.692101.29
5389237-389237100.304100.90
6389413-389413100.349100.94
极限1379824-37982497.87899.651.4098.63100.411.40
2391079-391079100.778101.55
3379760-37976097.86298.61
4390666-390666100.672101.44
5389797-389797100.448101.21
6389002-389002100.243101.00
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