比拉斯汀口崩片项目信息
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%
111.133813673815083809013810733815073812710.08
211.173822903819643821270.07
单位质量响应值RSD%判断
34256.1534210.120.10数据可信
加速6月-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%
5min1221556-22155658.01558.851.1458.0158.851.14
2227582-22758259.59359.59
3226548-22654859.32259.32
4221682-22168258.04858.05
5225190-22519058.96658.97
6225967-22596759.17059.17
10min1325677-32567785.27984.781.3785.3884.881.37
2328762-32876286.08786.19
3327987-32798785.88485.98
4322405-32240584.42284.52
5318004-31800483.27083.37
6319809-31980983.74383.84
15min1367748-36774896.29595.681.1496.5395.921.14
2366687-36668796.01896.26
3371642-37164297.31597.56
4364044-36404495.32695.56
5360261-36026194.33594.57
6362092-36209294.81495.05
20min1380246-38024699.56899.261.0499.9799.661.04
2383082-383082100.311100.71
3383194-383194100.340100.74
4377642-37764298.88699.28
5373006-37300697.67298.07
6377206-37720698.77299.17
30min1384411-384411100.659100.400.80101.22100.960.80
2382983-382983100.285100.85
3388076-388076101.618102.19
4383380-383380100.389100.95
5378635-37863599.14699.70
6382938-382938100.273100.83
极限1384566-384566100.699100.320.91101.43101.060.91
2380851-38085199.726100.46
3388648-388648101.768102.51
4382851-382851100.250100.98
5378403-37840399.08599.81
6383504-383504100.421101.15
比拉斯汀口崩片项目信息
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%
111.133818313815993823503818223821033819410.08
211.173835063832113833580.06
单位质量响应值RSD%判断
34316.3534320.320.01数据可信
中间条件6月-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%
5min1243593-24359363.62762.334.7163.6362.334.71
2244539-24453963.87463.87
3236026-23602661.65061.65
4243534-24353463.61163.61
5247150-24715064.55664.56
6217001-21700156.68156.68
10min1344094-34409489.87887.213.5089.9887.323.50
2336667-33666787.93888.04
3330741-33074186.39086.49
4337867-33786788.25188.36
5341979-34197989.32589.43
6312041-31204181.50681.60
15min1374553-37455397.83495.841.6198.0996.091.62
2365308-36530895.41995.67
3364839-36483995.29695.54
4369037-36903796.39396.65
5370439-37043996.75997.02
6357315-35731593.33193.56
20min1382844-38284499.99998.231.32100.4298.641.33
2375312-37531298.03298.44
3371838-37183897.12597.53
4377919-37791998.71399.13
5379131-37913199.03099.45
6369297-36929796.46196.85
30min1385178-385178100.60999.590.58101.19100.160.58
2381787-38178799.723100.30
3379961-37996199.24699.81
4380951-38095199.505100.08
5381036-38103699.527100.11
6378745-37874598.92999.48
极限1385507-385507100.69599.250.93101.45100.000.93
2376319-37631998.29599.04
3376303-37630398.29199.02
4381249-38124999.583100.33
5381438-38143899.632100.38
6379146-37914699.03399.75
比拉斯汀口崩片项目信息
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%
111.133805883806083808443811423808303808020.06
211.173809793810293810040.01
单位质量响应值RSD%判断
34214.0234109.580.22数据可信
加速6月-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%
5min1237540-23754062.33063.812.6962.3363.822.69
2242115-24211563.53163.53
3254345-25434566.74066.74
4237123-23712362.22162.22
5246992-24699264.81064.81
6241065-24106563.25563.26
10min1328159-32815986.10987.661.6686.2187.771.67
2340640-34064089.38489.49
3340909-34090989.45489.57
4329610-32961086.48986.59
5334075-33407587.66187.77
6331078-33107886.87586.98
15min1357670-35767093.85295.621.5394.1095.881.53
2373181-37318197.92298.18
3367172-36717296.34696.61
4359687-35968794.38294.63
5365446-36544695.89396.15
6363285-36328595.32695.58
20min1366224-36622496.09798.021.4596.5098.431.45
2382179-382179100.283100.70
3375164-37516498.44398.86
4370024-37002497.09497.50
5375029-37502998.40798.82
6372601-37260197.77098.18
30min1370258-37025897.15598.851.4797.7299.421.47
2384845-384845100.983101.57
3378803-37880399.39899.98
4370582-37058297.24097.81
5378069-37806999.20599.78
6377649-37764999.09599.67
极限1370925-37092597.33098.901.4198.0699.641.41
2384957-384957101.012101.77
3377937-37793799.17099.92
4371394-37139497.45398.18
5379633-37963399.615100.36
6376634-37663498.82899.57
比拉斯汀口崩片项目信息
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%
111.133811833817613808723812933812513812720.09
211.173815823815523815670.01
单位质量响应值RSD%判断
34256.2434159.980.20数据可信
中间条件6月-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%
5min1256483-25648367.21065.412.8567.2165.412.85
2250332-25033265.59865.60
3256361-25636167.17867.18
4237577-23757762.25662.26
5250745-25074565.70665.71
6246088-24608864.48664.49
10min1349368-34936891.55087.482.9291.6687.592.92
2337060-33706088.32488.43
3338124-33812488.60388.72
4324469-32446985.02585.13
5330200-33020086.52786.64
6323745-32374584.83584.94
15min1376548-37654898.67294.752.4898.9495.012.48
2365232-36523295.70795.96
3362499-36249994.99195.25
4357350-35735093.64193.89
5357735-35773593.74294.00
6350173-35017391.76192.01
20min1383853-383853100.58697.162.25101.0297.582.25
2376295-37629598.60699.02
3369313-36931396.77697.19
4367935-36793596.41596.82
5367791-36779196.37796.79
6359577-35957794.22594.63
30min1388201-388201101.72698.112.23102.3298.682.23
2380459-38045999.697100.28
3371654-37165497.39097.97
4370604-37060497.11497.68
5369706-36970696.87997.45
6365763-36576395.84696.40
极限1386785-386785101.35597.902.34102.1298.642.34
2379905-37990599.552100.30
3369207-36920796.74897.49
4372710-37271097.66698.39
5371303-37130397.29898.03
6361703-36170394.78295.50
比拉斯汀口崩片项目信息
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%
111.133813163810443810853809433816523812080.08
211.173804233806773805500.05
单位质量响应值RSD%判断
34250.4934068.930.38数据可信
加速6月-供试品溶液-2024122021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%
5min1266249-26624969.86868.303.2569.8768.303.25
2269556-26955670.73670.74
3265615-26561569.70269.70
4256300-25630067.25767.26
5246871-24687164.78364.78
6257129-25712967.47567.47
10min1341048-34104889.49789.071.3889.6189.191.38
2344457-34445790.39190.51
3340509-34050989.35589.47
4341137-34113789.52089.63
5330647-33064786.76786.88
6338827-33882788.91489.03
15min1362146-36214695.03395.531.2895.3095.801.28
2366433-36643396.15896.43
3363489-36348995.38595.65
4369351-36935196.92497.18
5356160-35616093.46293.71
6366755-36675596.24296.50
20min1369959-36995997.08397.361.1997.5197.781.19
2370299-37029997.17297.60
3369828-36982897.04997.47
4377001-37700198.93199.35
5364361-36436195.61496.02
6374649-37464998.31498.74
30min1371595-37159597.51397.901.1498.1098.481.14
2373875-37387598.11198.70
3371281-37128197.43098.02
4377196-37719698.98299.57
5366532-36653296.18496.75
6377894-37789499.16699.75
极限1371448-37144897.47497.681.1498.2298.431.14
2374080-37408098.16598.92
3370280-37028097.16797.92
4375369-37536998.50399.26
5365246-36524695.84696.57
6377011-37701198.93499.68
比拉斯汀口崩片项目信息
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%
111.133815263822033824643818633822083820530.10
211.173815573821263818420.11
单位质量响应值RSD%判断
34326.4234184.600.30数据可信
中间条件6月-供试品溶液-2024122021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%
5min1266695-26669569.78970.131.8769.7970.131.87
2265525-26552569.48369.48
3273177-27317771.48571.49
4274850-27485071.92371.92
5265966-26596669.59869.60
6261742-26174268.49368.49
10min1357027-35702793.42790.821.9293.5490.941.92
2349530-34953091.46691.58
3347162-34716290.84690.97
4349263-34926391.39691.52
5338311-33831188.53088.65
6341140-34114089.27089.38
15min1373843-37384397.82896.761.7498.1097.031.73
2376150-37615098.43298.70
3371329-37132997.17097.44
4373027-37302797.61497.89
5359222-35922294.00294.27
6364927-36492795.49595.76
20min1378940-37894099.16298.231.4999.6098.661.49
2379477-37947799.30299.73
3377889-37788998.88799.32
4379518-37951899.31399.75
5367388-36738896.13996.56
6369097-36909796.58697.01
30min1381853-38185399.92498.811.55100.5299.401.55
2383006-383006100.226100.82
3378743-37874399.11099.71
4381322-38132299.785100.39
5369256-36925696.62897.21
6371421-37142197.19497.78
极限1381642-38164299.86998.571.51100.6499.331.50
2381108-38110899.729100.49
3376206-37620698.44699.21
4380810-38081099.651100.42
5367653-36765396.20896.95
6372596-37259697.50298.25
比拉斯汀口崩片项目信息
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%
111.133794413797423794973806443805463799740.16
211.173789893800763795320.21
单位质量响应值RSD%判断
34139.6233977.800.34数据可信
加速6月-供试品溶液-3L77C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%
5min1237048-23704862.39061.501.6962.3961.501.70
2234185-23418561.63661.64
3232225-23222561.12061.12
4229380-22938060.37160.37
5229923-22992360.51460.51
6239304-23930462.98362.98
10min1318445-31844583.81382.361.1583.9282.471.15
2313977-31397782.63782.74
3310972-31097281.84681.95
4308502-30850281.19681.30
5310686-31068681.77181.87
6315058-31505882.92183.03
15min1347998-34799891.59190.831.0691.8391.071.05
2349785-34978592.06192.30
3345308-34530890.88391.12
4339334-33933489.31189.55
5343726-34372690.46790.70
6344485-34448590.66690.91
20min1362055-36205595.29194.100.9595.6994.490.94
2359426-35942694.59994.99
3358052-35805294.23794.63
4352441-35244192.76093.15
5355097-35509793.45993.85
6358072-35807294.24294.64
30min1367707-36770796.77896.221.1897.3396.771.18
2368870-36887097.08497.64
3363683-36368395.71996.27
4358664-35866494.39894.94
5364162-36416295.84596.39
6370468-37046897.50598.06
极限1371690-37169097.82796.661.4498.5497.361.44
2373555-37355598.31799.03
3365277-36527796.13996.85
4358586-35858694.37895.07
5366672-36667296.50697.21
6367666-36766696.76897.48
比拉斯汀口崩片项目信息
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%
111.133799883798883799833802583803633800960.06
211.173794853803403799120.16
单位质量响应值RSD%判断
34150.5834011.820.29数据可信
中间条件6月-供试品溶液-3L77C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%
5min1237271-23727162.40761.631.7162.4161.631.71
2228600-22860060.12660.13
3234819-23481961.76261.76
4235219-23521961.86761.87
5239231-23923162.92362.92
6230657-23065760.66760.67
10min1315446-31544682.96982.411.5383.0782.511.53
2317179-31717983.42483.52
3308683-30868381.19081.29
4306474-30647480.60980.71
5318381-31838183.74183.85
6313787-31378782.53282.63
15min1342334-34233490.04190.531.1990.2890.771.19
2347562-34756291.41691.66
3338316-33831688.98489.22
4342346-34234690.04490.28
5345041-34504190.75391.00
6349588-34958891.94992.19
20min1348151-34815191.57193.711.7191.9694.101.70
2361900-36190095.18795.58
3351517-35151792.45692.84
4353391-35339192.94993.34
5360192-36019294.73895.13
6362635-36263595.38095.77
30min1353908-35390893.08595.331.8493.6395.881.83
2365723-36572396.19296.74
3357416-35741694.00894.55
4359089-35908994.44894.99
5367242-36724296.59297.15
6371247-37124797.64598.20
极限1353394-35339492.95095.702.0593.6596.412.04
2365847-36584796.22596.94
3358028-35802894.16994.87
4362551-36255195.35896.06
5370285-37028597.39298.11
6373101-37310198.13398.85
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