比拉斯汀片项目信息
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%
111.213866783866483867303867693863333866320.05
211.233861563867433864500.11
单位质量响应值RSD%判断
34489.9234412.290.16数据可信
供试品溶液-24052201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%
5min1280761-28076173.05374.064.2773.0574.064.27
2275543-27554371.69571.69
3272835-27283570.99070.99
4278969-27896972.58672.59
5298291-29829177.61477.61
6301382-30138278.41878.42
10min1326302-32630284.90288.144.5385.0288.264.53
2329051-32905185.61785.74
3330931-33093186.10786.22
4330594-33059486.01986.14
5351971-35197191.58191.71
6363700-36370094.63394.76
15min1342629-34262989.15091.944.1489.4192.214.14
2341081-34108188.74889.01
3345680-34568089.94490.21
4348616-34861690.70890.97
5364086-36408694.73395.02
6377917-37791798.33298.62
20min1348457-34845790.66793.394.3091.0893.814.30
2345949-34594990.01490.42
3352014-35201491.59292.00
4351124-35112491.36191.78
5371703-37170396.71597.16
6384210-38421099.970100.42
30min1360996-36099693.92995.423.2994.4996.003.29
2356503-35650392.76093.32
3360620-36062093.83294.40
4359827-35982793.62594.19
5374908-37490897.54998.15
6387573-387573100.845101.46
45min1364221-36422194.76996.532.7495.4997.262.75
2364078-36407894.73195.45
3367178-36717895.53896.26
4365528-36552895.10995.83
5374864-37486497.53898.30
6390007-390007101.478102.26
60min1369900-36990096.24696.882.4197.1297.782.42
2365591-36559195.12596.00
3367630-36763095.65696.54
4367109-36710995.52096.40
5374213-37421397.36898.29
6389540-389540101.356102.31
极限1375399-37539997.67797.991.5998.7199.051.61
2371442-37144296.64797.68
3375181-37518197.62098.66
4372985-37298597.04998.09
5376414-37641497.94199.03
6388260-388260101.023102.15
比拉斯汀片项目信息
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%
111.213862983867893862183868643866123865560.08
211.233862813862493862650.01
单位质量响应值RSD%判断
34483.1434395.810.18数据可信
供试品溶液-24052202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%
5min1318217-31821782.82780.023.3782.8380.023.37
2306176-30617679.69279.69
3293046-29304676.27576.27
4303284-30328478.94078.94
5320612-32061283.45083.45
6303210-30321078.92078.92
10min1367113-36711395.55393.742.4095.6993.872.41
2360470-36047093.82493.96
3347337-34733790.40690.53
4357272-35727292.99293.12
5371984-37198496.82196.96
6356629-35662992.82592.96
15min1378714-37871498.57396.081.6598.8796.371.65
2369154-36915496.08596.37
3360854-36085493.92494.20
4367706-36770695.70895.99
5372535-37253596.96597.27
6365882-36588295.23395.52
20min1378906-37890698.62397.101.1999.0897.541.20
2375265-37526597.67598.12
3368344-36834495.87496.31
4370244-37024496.36896.81
5376526-37652698.00398.47
6368931-36893196.02796.47
30min1381755-38175599.36497.791.1399.9998.401.13
2378823-37882398.60199.21
3373667-37366797.25997.85
4373757-37375797.28397.89
5376463-37646397.98798.61
6369887-36988796.27596.88
45min1378265-37826598.45698.320.8799.2599.100.87
2382157-38215799.469100.25
3378637-37863798.55399.31
4378923-37892398.62799.40
5376080-37608097.88798.68
6372394-37239496.92897.69
60min1380489-38048999.03598.370.9699.9999.310.96
2381420-38142099.277100.22
3380048-38004898.92099.84
4378463-37846398.50899.44
5375266-37526697.67598.63
6372018-37201896.83097.76
极限1376298-37629897.94497.961.3999.0699.061.38
2384651-384651100.118101.23
3379746-37974698.84199.93
4372652-37265296.99598.09
5374523-37452397.48298.60
6370199-37019996.35797.44
比拉斯汀片项目信息
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%
111.213889853887523882703885663884863886120.07
211.233880513882363881440.04
单位质量响应值RSD%判断
34666.5534563.130.22数据可信
供试品溶液-24052201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%
5min1232038-23203860.09060.011.4260.0960.011.42
2237803-23780361.58361.58
3229069-22906959.32159.32
4232140-23214060.11660.12
5230450-23045059.67859.68
6228868-22886859.26959.27
10min1301700-30170078.13077.861.3278.2377.961.32
2304270-30427078.79578.90
3295499-29549976.52476.62
4299145-29914577.46877.57
5305718-30571879.17079.27
6297668-29766877.08577.18
15min1329714-32971485.38484.641.4685.6184.861.46
2327886-32788684.91185.14
3320207-32020782.92283.15
4326039-32603984.43384.66
5333706-33370686.41886.65
6323374-32337483.74283.97
20min1343738-34373889.01687.791.6789.3988.161.67
2339850-33985088.00988.38
3330074-33007485.47785.84
4337868-33786887.49687.87
5345986-34598689.59889.97
6336504-33650487.14387.51
30min1357577-35757792.60090.631.9093.1291.151.90
2350122-35012290.66991.19
3339894-33989488.02188.53
4347500-34750089.99090.51
5357072-35707292.46992.99
6347715-34771590.04690.56
45min1365007-36500794.52492.272.0495.2092.942.04
2354937-35493791.91692.59
3344690-34469089.26389.92
4354689-35468991.85292.52
5363210-36321094.05994.74
6355193-35519391.98292.64
60min1369337-36933795.64593.241.9296.4894.061.91
2356992-35699292.44893.27
3349791-34979190.58491.39
4359518-35951893.10293.92
5365865-36586594.74695.58
6358736-35873692.90093.72
极限1382269-38226998.99497.611.6599.9998.591.63
2383007-38300799.185100.17
3375903-37590397.34698.30
4369337-36933795.64596.62
5369917-36991795.79596.79
6381140-38114098.70299.67
比拉斯汀片项目信息
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%
111.213877383872163875343868873869313872610.10
211.233888583878223883400.19
单位质量响应值RSD%判断
34546.0334580.590.08数据可信
供试品溶液-24052202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%
5min1257361-25736166.74765.172.9766.7565.172.97
2249875-24987564.80564.81
3241326-24132662.58862.59
4259458-25945867.29067.29
5255704-25570466.31766.32
6243937-24393763.26563.27
10min1324089-32408984.05381.972.4684.1682.082.46
2318110-31811082.50282.61
3321131-32113183.28583.39
4312728-31272881.10681.22
5318014-31801482.47782.59
6302193-30219378.37478.48
15min1350531-35053190.91088.242.9691.1688.482.95
2341466-34146688.55988.80
3349375-34937590.61090.85
4332241-33224186.16786.41
5343072-34307288.97689.22
6324660-32466084.20184.44
20min1360233-36023393.42791.022.9293.8391.412.91
2352066-35206691.30891.70
3362053-36205393.89994.29
4342858-34285888.92089.31
5353037-35303791.56091.96
6335373-33537386.97987.36
30min1367423-36742395.29193.323.1995.8593.863.18
2361483-36148393.75194.30
3374009-37400996.99997.55
4350675-35067590.94891.49
5362847-36284794.10494.65
6342424-34242488.80889.33
45min1373779-37377996.94094.982.9897.6695.682.98
2365835-36583594.87995.58
3381901-38190199.04699.76
4357734-35773492.77893.47
5366783-36678395.12595.83
6351398-35139891.13591.80
60min1377022-37702297.78195.612.7298.6696.472.71
2366724-36672495.11095.97
3383892-38389299.562100.44
4360942-36094293.61094.46
5366060-36606094.93895.80
6357332-35733292.67493.50
极限1380721-38072198.74097.521.9199.7898.541.90
2368078-36807895.46196.48
3385884-385884100.079101.12
4378290-37829098.11099.11
5367758-36775895.37896.40
6375421-37542197.36698.34
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