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%
110.993796703797343796103794663800073796970.06
211.073796873798613797740.04
单位质量响应值RSD%判断
34549.3234306.590.50数据可信
供试品溶液-24062601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%
5min1279204-27920472.69773.772.2672.7073.772.26
2273959-27395971.33271.33
3289038-28903875.25875.26
4289474-28947475.37175.37
5280390-28039073.00673.01
6287923-28792374.96774.97
10min1333044-33304486.71689.192.1186.8489.322.11
2336465-33646587.60687.73
3349231-34923190.93091.06
4349698-34969891.05291.18
5339213-33921388.32288.44
6347691-34769190.52990.65
15min1346908-34690890.32592.792.4790.5993.072.47
2346162-34616290.13190.40
3363331-36333194.60294.88
4363969-36396994.76895.05
5352937-35293791.89592.16
6365017-36501795.04195.32
20min1352369-35236991.74794.061.9792.1694.481.97
2355652-35565292.60293.02
3365911-36591195.27395.71
4365378-36537895.13595.57
5357534-35753493.09293.51
6370626-37062696.50196.94
30min1360647-36064793.90395.941.8194.4796.521.81
2362027-36202794.26294.83
3373013-37301397.12397.72
4373599-37359997.27597.87
5365337-36533795.12495.70
6376261-37626197.96898.56
45min1366663-36666395.46997.621.5496.1998.361.54
2371618-37161896.75997.49
3377623-37762398.32399.08
4381370-38137099.298100.05
5371940-37194096.84397.58
6380221-38022198.99999.76
60min1370090-37009096.36198.221.2797.2599.121.27
2377328-37732898.24699.13
3375922-37592297.88098.80
4381769-38176999.402100.32
5375021-37502197.64598.54
6383242-38324299.786100.71
极限1375732-37573297.83099.451.1398.88100.521.13
2379738-37973898.87499.93
3381214-38121499.258100.34
4385918-385918100.483101.57
5381555-38155599.347100.41
6387585-387585100.917102.01
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%
110.993803683799453800913796043795283799070.10
211.073798193799833799010.04
单位质量响应值RSD%判断
34568.4334318.070.52数据可信
供试品溶液-24071001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%
5min1283407-28340773.75979.054.0173.7679.054.00
2296203-29620377.08977.09
3317929-31792982.74382.74
4308049-30804980.17280.17
5309940-30994080.66480.66
6306928-30692879.88079.88
10min1341767-34176788.94793.512.8789.0793.642.87
2354248-35424892.19692.32
3371861-37186196.78096.92
4364346-36434694.82494.96
5362425-36242594.32494.46
6361054-36105493.96794.10
15min1355552-35555292.53596.722.5492.8197.012.54
2367285-36728595.58995.87
3383162-38316299.721100.02
4376246-37624697.92198.21
5375053-37505397.61097.90
6372561-37256196.96297.25
20min1360715-36071593.87997.632.4194.3098.082.41
2369099-36909996.06196.50
3386442-386442100.574101.04
4379949-37994998.88599.34
5377974-37797498.37198.82
6376537-37653797.99798.45
30min1368451-36845195.89298.051.6396.4798.661.64
2373633-37363397.24197.84
3385579-385579100.350100.98
4380536-38053699.03799.66
5378998-37899898.63799.26
6373296-37329697.15397.77
45min1371723-37172396.74498.651.3297.4999.431.32
2374562-37456297.48398.25
3385240-385240100.262101.06
4381642-38164299.325100.11
5380599-38059999.05499.84
6380575-38057599.04899.82
60min1372738-37273897.00898.731.4297.9199.671.43
2375179-37517997.64398.57
3388455-388455101.098102.07
4379918-37991898.87799.83
5379795-37979598.84599.79
6380094-38009498.92299.86
极限1375921-37592197.83698.861.1898.9099.971.18
2375895-37589597.83098.92
3387795-387795100.927102.06
4380838-38083899.116100.23
5378115-37811598.40799.52
6380660-38066099.070100.18
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%
110.993798293799423798823794783795383797340.06
211.073804823801673803240.06
单位质量响应值RSD%判断
34552.6834356.280.41数据可信
供试品溶液-24071002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%
5min1289126-28912675.22275.402.0075.2275.402.00
2284287-28428773.96373.96
3293033-29303376.23976.24
4299804-29980478.00078.00
5285828-28582874.36474.36
6286720-28672074.59674.60
10min1334890-33489087.12988.001.6887.2588.121.68
2333253-33325386.70386.83
3337155-33715587.71887.85
4347324-34732490.36490.49
5333845-33384586.85786.98
6342856-34285689.20189.33
15min1346892-34689290.25192.312.3990.5292.582.39
2349839-34983991.01891.29
3358080-35808093.16293.44
4368822-36882295.95796.24
5347387-34738790.38090.65
6357761-35776193.07993.35
20min1352677-35267791.75693.642.4692.1894.072.46
2356260-35626092.68993.11
3361642-36164294.08994.52
4373663-37366397.21697.66
5349791-34979191.00691.42
6365500-36550095.09395.52
30min1359101-35910193.42895.421.9994.0096.001.99
2363186-36318694.49195.06
3369010-36901096.00696.59
4377931-37793198.32798.93
5360116-36011693.69294.26
6371185-37118596.57297.16
45min1366719-36671995.41096.332.1096.1497.072.10
2364064-36406494.71995.45
3373342-37334297.13397.88
4380967-38096799.11799.88
5360595-36059593.81794.54
6375926-37592697.80598.55
60min1367971-36797195.73696.952.2296.6297.862.22
2360143-36014393.69994.59
3376823-37682398.03998.95
4381624-38162499.288100.22
5369329-36932996.08996.97
6380003-38000398.86699.78
极限1374739-37473997.49698.361.3798.5499.421.38
2379064-37906498.62299.67
3382970-38297099.638100.71
4382200-38220099.438100.53
5369300-36930096.08197.12
6380066-38006698.88299.96
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%
110.993792203792493793053793533795773793410.04
211.073798223799613798920.03
单位质量响应值RSD%判断
34516.9234317.250.42数据可信
供试品溶液-3401B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%
5min1245026-24502663.81862.311.6963.8262.301.69
2242485-24248563.15663.16
3235291-23529161.28361.28
4240391-24039162.61162.61
5236068-23606861.48561.48
6236046-23604661.47961.48
10min1310884-31088480.97180.531.1581.0880.641.16
2310835-31083580.95881.06
3306996-30699679.95880.06
4309773-30977380.68280.79
5303318-30331879.00079.10
6313427-31342781.63381.74
15min1332156-33215686.51187.071.4586.7587.311.45
2336757-33675787.71087.95
3328643-32864385.59685.83
4334875-33487587.22087.46
5331134-33113486.24586.48
6342293-34229389.15289.39
20min1343608-34360889.49490.011.1389.8890.391.13
2346066-34606690.13490.52
3344087-34408789.61990.00
4345135-34513589.89290.28
5341621-34162188.97789.35
6352919-35291991.91992.31
30min1351076-35107691.43992.501.5791.9793.031.56
2357742-35774293.17593.71
3356050-35605092.73593.26
4349679-34967991.07591.61
5351783-35178391.62392.15
6364606-36460694.96395.50
45min1355016-35501692.46594.331.7493.1595.021.73
2362141-36214194.32195.01
3361543-36154394.16594.85
4362276-36227694.35695.04
5358521-35852193.37894.06
6373634-37363497.31598.01
60min1357595-35759593.13794.741.5793.9895.581.56
2363335-36333594.63295.48
3363321-36332194.62895.47
4365028-36502895.07395.92
5359316-35931693.58594.42
6373824-37382497.36498.22
极限1365892-36589295.29896.511.4596.2997.521.45
2368583-36858395.99997.01
3369459-36945996.22797.22
4374897-37489797.64398.65
5365497-36549795.19596.19
6379048-37904898.72599.75
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