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%
110.903804013803323804883800883797683802150.08
210.983798273801343799800.06
单位质量响应值RSD%判断
34882.1134606.560.57数据可信
供试品溶液-2024121821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%
5min1260289-26028967.15565.391.5667.1665.391.57
2254555-25455565.67665.68
3252313-25231365.09865.10
4251048-25104864.77164.77
5253783-25378365.47765.48
6248658-24865864.15564.15
10min1331065-33106585.41684.301.3685.5384.411.36
2326891-32689184.33984.45
3324208-32420883.64783.76
4329712-32971285.06785.17
5329410-32941084.98985.10
6319229-31922982.36282.47
15min1361863-36186393.36292.121.3093.6292.371.30
2357979-35797992.36092.61
3355467-35546791.71291.96
4357765-35776592.30492.55
5360438-36043892.99493.24
6348744-34874489.97790.22
20min1378424-37842497.63596.311.7798.0496.711.77
2373319-37331996.31796.72
3370509-37050995.59295.99
4373712-37371296.41996.82
5381343-38134398.38898.79
6362434-36243493.50993.90
30min1389673-389673100.53798.901.41101.1199.461.41
2383968-38396899.06599.63
3381544-38154498.43999.00
4384244-38424499.13699.70
5386672-38667299.763100.33
6373896-37389696.46697.02
极限1392883-392883101.36599.841.47102.11100.571.46
2386534-38653499.727100.46
3389740-389740100.554101.28
4386940-38694099.832100.56
5389360-389360100.456101.19
6376415-37641597.11697.83
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%
110.903796933798913792263794253791453794760.09
210.983801303805883803590.09
单位质量响应值RSD%判断
34814.3134641.070.36数据可信
供试品溶液-2024121821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%
5min1252448-25244865.16365.051.3665.1665.051.35
2248696-24869664.19464.19
3256859-25685966.30266.30
4252220-25222065.10465.10
5254157-25415765.60465.60
6247696-24769663.93663.94
10min1327581-32758184.55784.140.9884.6784.240.98
2322475-32247583.23983.35
3328527-32852784.80184.91
4326909-32690984.38384.49
5328792-32879284.86984.98
6321406-32140682.96383.07
15min1367378-36737894.82992.451.5295.0892.701.52
2355099-35509991.66091.91
3358467-35846792.52992.78
4354667-35466791.54891.80
5360998-36099893.18293.43
6352385-35238590.95991.20
20min1374596-37459696.69295.850.8797.1096.250.87
2368202-36820295.04295.44
3374797-37479796.74497.15
4368744-36874495.18295.58
5373233-37323396.34096.75
6368398-36839895.09295.49
30min1383709-38370999.04598.630.7199.6199.190.71
2380260-38026098.15498.71
3385389-38538999.478100.05
4378704-37870497.75398.31
5384219-38421999.17699.74
6380279-38027998.15998.71
极限1387472-387472100.01699.780.99100.75100.500.98
2391209-391209100.980101.70
3388276-388276100.223100.96
4382413-38241398.71099.43
5388457-388457100.270101.00
6381471-38147198.46799.19
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%
110.903800463800263806903804123802243802800.08
210.983801233799863800540.03
单位质量响应值RSD%判断
34888.0734613.300.56数据可信
供试品溶液-2024121921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%
5min1243391-24339162.78463.420.7662.7863.420.76
2246304-24630463.53663.54
3244486-24448663.06763.07
4245470-24547063.32063.32
5246898-24689863.68963.69
6248626-24862664.13564.13
10min1320491-32049182.67383.350.7682.7883.460.76
2324946-32494683.82283.93
3320663-32066382.71782.82
4322019-32201983.06783.17
5324127-32412783.61083.72
6326440-32644084.20784.31
15min1354129-35412991.35092.250.9791.5992.490.97
2359825-35982592.81993.06
3355244-35524491.63791.88
4355147-35514791.61291.86
5358173-35817392.39392.64
6363139-36313993.67493.92
20min1370356-37035695.53596.891.4195.9397.291.41
2377134-37713497.28497.68
3371948-37194895.94696.34
4371114-37111495.73196.13
5383072-38307298.81699.22
6380097-38009798.04898.45
30min1383215-38321598.85399.971.1399.41100.541.12
2390986-390986100.857101.42
3384343-38434399.14399.70
4384291-38429199.13099.69
5388521-388521100.221100.79
6394013-394013101.638102.20
极限1390090-390090100.626101.310.91101.34102.040.92
2394054-394054101.649102.38
3389609-389609100.502101.22
4390301-390301100.680101.40
5393472-393472101.498102.23
6398940-398940102.909103.65
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%
110.903795393802083797823797713800363798670.07
210.983811503809223810360.05
单位质量响应值RSD%判断
34850.1834702.730.30数据可信
供试品溶液-2024121921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%
5min1279537-27953772.05465.415.1572.0565.415.15
2250173-25017364.48564.49
3245716-24571663.33663.34
4244988-24498863.14963.15
5254259-25425965.53865.54
6247883-24788363.89563.89
10min1349710-34971090.14284.993.3590.2685.103.35
2329989-32998985.05985.17
3320452-32045282.60082.71
4319723-31972382.41282.52
5332653-33265385.74585.85
6325910-32591084.00784.11
15min1371922-37192295.86793.292.1196.1493.542.11
2364981-36498194.07894.33
3353640-35364091.15591.40
4353396-35339691.09291.33
5367749-36774994.79295.04
6359773-35977392.73692.98
20min1386357-38635799.58897.531.85100.0297.941.85
2380987-38098798.20498.61
3369850-36985095.33395.73
4371365-37136595.72496.12
5385268-38526899.30799.72
6376439-37643997.03297.43
30min1391240-391240100.847100.251.46101.44100.821.47
2392577-392577101.191101.76
3382043-38204398.47699.03
4383486-38348698.84899.40
5396858-396858102.295102.87
6387378-38737899.851100.41
极限1397639-397639102.496101.151.49103.26101.881.50
2395227-395227101.874102.61
3386194-38619499.546100.26
4385355-38535599.330100.05
5399061-399061102.863103.61
6391015-391015100.789101.52
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