贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159403169397739398349389159392739396220.06
211.179400089397199398640.03
单位质量响应值RSD%判断
84271.0384141.810.11数据可信
供试品溶液-2024092721批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1314649-31464933.54634.8319.8633.5534.8319.87
2336632-33663235.88935.89
3400376-40037642.68542.69
4384631-38463141.00741.01
5304633-30463332.47832.48
6219326-21932623.38323.38
10min1698389-69838974.45777.2610.3974.8377.6410.44
2748031-74803179.75080.15
3821079-82107987.53888.01
4767316-76731681.80682.26
5714512-71451276.17676.54
6598639-59863963.82364.08
15min1890422-89042294.93195.261.1996.1396.511.30
2896079-89607995.53496.82
3906972-90697296.69598.14
4886312-88631294.49295.86
5902954-90295496.26797.47
6878491-87849193.65994.63
20min1909022-90902296.91497.631.5099.1799.941.46
2906152-90615296.60898.95
3903695-90369596.34698.87
4926254-92625498.751101.17
5938481-938481100.054102.33
6910925-91092597.11799.13
30min1910472-91047297.06897.331.36100.40100.711.18
2904109-90410996.39099.81
3898317-89831795.77299.36
4908788-90878896.889100.40
5926666-92666698.795102.18
6928979-92897999.041102.13
45min1911362-91136297.16396.071.60101.57100.541.54
2876630-87663093.46097.95
3899143-89914395.860100.52
4903946-90394696.372100.96
5918415-91841597.915102.40
6897265-89726595.66099.85
60min1877864-87786493.59294.911.0999.08100.451.00
2887554-88755494.625100.15
3883572-88357294.20099.92
4889535-88953594.836100.50
5904313-90431396.412101.99
6898435-89843595.785101.04
极限1888743-88874394.75296.281.60101.28102.871.53
2925373-92537398.657105.24
3900893-90089396.047102.81
4892867-89286795.191101.90
5915639-91563997.619104.26
6894771-89477195.394101.71
贝派度酸依折麦布片项目信息
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对照品来源中检院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100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162561792561672563982557892553592559780.17
210.192558912561542560220.08
单位质量响应值RSD%判断
25194.6925124.830.20数据可信
供试品溶液-2024092721批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145500-4550018.03419.2618.9718.0319.2618.98
251465-5146520.39820.40
360097-6009723.81923.82
455682-5568222.06922.07
544739-4473917.73217.73
634114-3411413.52113.52
10min1112615-11261544.63546.8712.1644.8447.0912.19
2124719-12471949.43249.66
3136813-13681354.22654.49
4125988-12598849.93550.18
5114460-11446045.36645.56
694994-9499437.65137.80
15min1156967-15696762.21463.293.6562.9164.023.76
2165609-16560965.63966.41
3165731-16573165.68766.55
4161803-16180364.13064.93
5157180-15718062.29863.00
6150780-15078059.76160.33
20min1175382-17538269.51271.112.4970.9072.552.58
2182630-18263072.38573.89
3180329-18032971.47373.07
4184124-18412472.97774.49
5181406-18140671.90073.29
6172663-17266368.43569.67
30min1195950-19595077.66478.691.1979.8280.921.23
2202188-20218880.13782.45
3197051-19705178.10180.49
4200550-20055079.48881.81
5197307-19730778.20280.39
6198233-19823378.56980.56
45min1214902-21490285.17684.900.7688.2088.000.86
2214138-21413884.87388.07
3214491-21449185.01388.27
4216582-21658285.84289.05
5213324-21332484.55187.61
6211733-21173383.92086.79
60min1217875-21787586.35488.161.5490.3292.201.50
2227727-22772790.25994.40
3220001-22000187.19791.40
4223415-22341588.55092.71
5221674-22167487.86091.86
6223837-22383788.71792.52
极限1227793-22779390.28592.352.4695.2197.382.41
2244259-24425996.812101.96
3230759-23075991.46196.63
4232168-23216892.01997.16
5231713-23171391.83996.82
6231315-23131591.68196.47
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