贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053061313060213062533060013062873061390.05
210.013065363062033063700.08
单位质量响应值RSD%判断
30461.5930606.390.34数据可信
供试品溶液-24062501批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180675-8067526.34830.7912.0026.3530.7912.00
2105456-10545634.44134.44
3100404-10040432.79132.79
4102342-10234233.42433.42
597347-9734731.79231.79
679510-7951025.96725.97
10min1246324-24632480.44782.422.0880.7482.762.11
2257628-25762884.13884.52
3259100-25910084.61984.98
4248938-24893881.30081.67
5253622-25362282.83083.18
6248520-24852081.16481.45
15min1282568-28256892.28493.260.8293.4794.520.87
2288544-28854494.23595.55
3287889-28788994.02195.33
4285347-28534793.19194.47
5285339-28533993.18894.46
6283604-28360492.62293.81
20min1292100-29210095.39796.060.6497.6198.360.68
2296486-29648696.82999.19
3295910-29591096.64198.99
4294852-29485296.29598.61
5292919-29291995.66497.97
6292585-29258595.55597.77
30min1297403-29740397.12897.190.50100.40100.550.53
2299740-29974097.892101.33
3297828-29782897.267100.69
4298606-29860697.521100.90
5296031-29603196.680100.05
6295925-29592596.64699.93
45min1300993-30099398.30197.340.73102.65101.780.71
2299537-29953797.825102.35
3298142-29814297.370101.87
4298404-29840497.455101.92
5295782-29578296.599101.05
6295356-29535696.460100.81
60min1303245-30324599.03697.460.96104.48102.980.91
2299453-29945397.798103.41
3297705-29770597.227102.81
4298870-29887097.608103.15
5295482-29548296.501102.02
6295740-29574096.585102.01
极限1307640-307640100.47298.311.23107.02104.911.13
2300261-30026198.062104.76
3297306-29730697.097103.76
4302082-30208298.657105.29
5298047-29804797.339103.93
6300713-30071398.209104.71
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053062423064453067513065033065953065070.07
210.013059943057923058930.05
单位质量响应值RSD%判断
30498.2130558.740.15数据可信
供试品溶液-24062401SP批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1128076-12807641.83641.968.9541.8441.968.94
2121558-12155839.70639.71
3122394-12239439.98039.98
4119239-11923938.94938.95
5150591-15059149.19049.19
6128946-12894642.12042.12
10min1259797-25979784.86284.522.0785.3384.992.10
2257060-25706083.96884.41
3256139-25613983.66784.11
4251044-25104482.00382.44
5266722-26672287.12487.67
6261761-26176185.50385.97
15min1288327-28832794.18193.701.8895.5995.101.92
2282826-28282692.38493.76
3284629-28462992.97394.35
4280155-28015591.51292.86
5295013-29501396.36597.88
6290113-29011394.76496.18
20min1294129-29412996.07696.031.7198.5398.481.75
2290138-29013894.77297.17
3291342-29134295.16697.57
4288556-28855694.25696.62
5301491-30149198.481101.07
6298229-29822997.41599.89
30min1297207-29720797.08297.201.69100.60100.711.72
2294261-29426196.11999.57
3294419-29441996.17199.64
4292219-29221995.45298.86
5304545-30454599.478103.16
6302768-30276898.898102.45
45min1296578-29657896.87697.291.63101.48101.891.67
2294942-29494296.342100.86
3294858-29485896.314100.85
4293041-29304195.721100.19
5305072-30507299.651104.44
6302636-30263698.855103.51
60min1296586-29658696.87997.211.71102.56102.881.74
2294221-29422196.106101.70
3294309-29430996.135101.74
4292727-29272795.618101.15
5305036-30503699.639105.53
6302697-30269798.875104.63
极限1299777-29977797.92197.461.49104.67104.211.54
2295192-29519296.423103.08
3295035-29503596.372103.04
4293554-29355495.888102.48
5304574-30457499.488106.49
6301999-30199998.647105.50
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