贝派度酸片项目信息
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%
19.782951652952972951332952072951632951930.03
29.742951782952092951940.01
单位质量响应值RSD%判断
30183.3330307.390.30数据可信
供试品溶液-24070802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%
5min179183-7918326.10723.1812.8526.1123.1812.85
266524-6652421.93321.93
360414-6041419.91919.92
483600-8360027.56327.56
567311-6731122.19322.19
664745-6474521.34721.35
10min1201369-20136966.39264.426.1066.4464.466.10
2193537-19353763.81063.85
3174988-17498857.69457.73
4210838-21083869.51469.56
5198558-19855865.46665.50
6193021-19302163.64063.68
15min1252898-25289883.38283.292.4283.5483.442.43
2251830-25183083.03083.17
3243238-24323880.19780.33
4261381-26138186.17986.34
5256398-25639884.53684.68
6250032-25003282.43782.58
20min1276080-27608091.02591.421.3091.3291.711.30
2278110-27811091.69491.98
3271713-27171389.58589.85
4280444-28044492.46492.77
5281603-28160392.84693.13
6275752-27575290.91791.20
30min1292083-29208396.30197.210.9696.7597.650.96
2296598-29659897.79098.22
3291863-29186396.22996.64
4294790-29479097.19497.65
5299320-29932098.68799.13
6294453-29445397.08397.51
45min1296775-29677597.84898.830.8898.4599.430.87
2302291-30229199.667100.26
3297945-29794598.23498.81
4298727-29872798.49299.11
5303521-303521100.072100.68
6299300-29930098.68199.27
60min1296748-29674897.83998.890.9298.6199.650.92
2302689-30268999.798100.56
3297516-29751698.09298.83
4299155-29915598.63399.42
5303631-303631100.109100.88
6299809-29980998.84899.61
极限1304988-304988100.556100.980.61101.49101.910.60
2306904-306904101.188102.12
3307744-307744101.465102.36
4303978-303978100.223101.17
5308848-308848101.829102.77
6305147-305147100.608101.53
贝派度酸片项目信息
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%
19.782956932957772957472957792957472957490.02
29.742950812954342952580.09
单位质量响应值RSD%判断
30240.1830313.960.18数据可信
供试品溶液-24071201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%
5min176369-7636925.15328.6215.0225.1528.6215.02
266310-6631021.84021.84
3102091-10209133.62533.62
491366-9136630.09230.09
593011-9301130.63430.63
692210-9221030.37030.37
10min1214430-21443070.62471.421.4970.6771.471.49
2212698-21269870.05470.09
3220481-22048172.61772.67
4215327-21532770.92070.97
5220348-22034872.57472.62
6217837-21783771.74671.80
15min1259093-25909385.33584.890.7385.4985.050.73
2256789-25678984.57684.73
3257343-25734384.75884.94
4254932-25493283.96484.13
5260331-26033185.74285.91
6257932-25793284.95285.12
20min1277443-27744391.37890.600.8391.6890.910.83
2275513-27551390.74391.04
3273432-27343290.05790.38
4271547-27154789.43689.74
5277318-27731891.33791.65
6275266-27526690.66190.97
30min1290539-29053995.69294.850.8596.1595.310.84
2289303-28930395.28495.73
3285697-28569794.09794.57
4284479-28447993.69694.15
5289876-28987695.47395.94
6288058-28805894.87495.34
45min1295483-29548397.32096.400.8697.9397.010.85
2293962-29396296.81997.42
3290548-29054895.69496.32
4289354-28935495.30195.91
5294979-29497997.15497.78
6291735-29173596.08596.71
60min1296498-29649897.65496.710.8398.4397.490.83
2294625-29462597.03797.80
3291391-29139195.97296.76
4290301-29030195.61396.39
5295678-29567897.38498.17
6293309-29330996.60497.38
极限1299552-29955298.66098.001.0999.6098.941.08
2302397-30239799.597100.52
3295754-29575497.40998.35
4292921-29292196.47697.41
5297448-29744897.96798.92
6297259-29725997.90598.85
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