富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.851648591645511649591648931643751647270.16
29.811652611649211650910.15
单位质量响应值RSD%判断
16723.5516828.850.45数据可信
供试品溶液-25052901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%
5min1188072-188072100.69598.281.89100.6998.281.89
2181175-18117597.00297.00
3181693-18169397.28097.28
4180328-18032896.54996.55
5187822-187822100.561100.56
6182321-18232197.61697.62
10min1189304-189304101.35598.771.51101.5298.941.51
2182321-18232197.61697.78
3183012-18301297.98698.15
4182117-18211797.50797.67
5186120-18612099.65099.82
6183997-18399798.51398.68
15min1188462-188462100.90498.601.49101.2498.931.49
2181225-18122597.02997.35
3182999-18299997.97998.30
4181822-18182297.34997.67
5185911-18591199.53899.87
6184539-18453998.80399.13
20min1189947-189947101.69998.501.86102.2098.991.85
2181272-18127297.05497.54
3182569-18256997.74998.24
4180615-18061596.70297.19
5185296-18529699.20999.71
6184123-18412398.58199.07
30min1188486-188486100.91798.341.52101.5999.001.52
2181156-18115696.99297.64
3182453-18245397.68798.34
4181321-18132197.08097.73
5185131-18513199.12099.79
6183481-18348198.23798.89
45min1187406-187406100.33898.231.39101.1899.051.39
2180879-18087996.84497.65
3182873-18287397.91198.73
4181199-18119997.01597.82
5185550-18555099.345100.17
6182881-18288197.91698.74
极限1187466-187466100.37197.801.58101.3898.781.58
2179289-17928995.99396.96
3182144-18214497.52198.50
4180489-18048996.63597.61
5184088-18408898.56299.56
6182501-18250197.71298.70
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.851658931661761664371663181662881662220.13
29.811655271652761654020.11
单位质量响应值RSD%判断
16875.3316860.550.07数据可信
供试品溶液-25052902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%
5min1188584-188584100.41998.891.04100.4298.891.04
2186745-18674599.44099.44
3186076-18607699.08499.08
4183719-18371997.82897.83
5183495-18349597.70997.71
6185679-18567998.87298.87
10min1189390-189390100.84899.470.92101.0299.640.92
2187297-18729799.73499.90
3187227-18722799.69699.86
4184180-18418098.07498.24
5186130-18613099.11299.28
6186562-18656299.34299.51
15min1189149-189149100.72099.201.07101.0699.531.07
2187055-18705599.60599.94
3186894-18689499.51999.85
4183195-18319597.54997.88
5185324-18532498.68399.01
6186117-18611799.10599.44
20min1187889-187889100.04999.050.92100.5599.550.92
2187312-18731299.742100.24
3186291-18629199.19899.70
4183388-18338897.65298.14
5184600-18460098.29898.79
6186612-18661299.36999.86
30min1188311-188311100.27498.930.93100.9499.600.93
2185983-18598399.03499.70
3185722-18572298.89599.56
4183306-18330697.60998.26
5184644-18464498.32198.98
6186792-18679299.465100.13
45min1188255-188255100.24498.700.98101.0899.530.97
2185628-18562898.84599.67
3185529-18552998.79299.62
4182729-18272997.30198.12
5184465-18446598.22699.05
6185536-18553698.79699.62
极限1205782-205782109.577100.194.65110.58101.184.61
2185787-18578798.93099.92
3185047-18504798.53699.53
4182880-18288097.38298.36
5183297-18329797.60498.59
6186099-18609999.096100.09
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.851661281666991663651661161663751663370.15
29.811665031660801662920.18
单位质量响应值RSD%判断
16887.0116951.270.27数据可信
供试品溶液-25052903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%
5min1180271-18027195.70298.552.0095.7098.552.01
2184204-18420497.79097.79
3189776-189776100.748100.75
4183030-18303097.16797.17
5187986-18798699.79899.80
6188572-188572100.109100.11
10min1180270-18027095.70299.382.3595.8699.552.35
2186057-18605798.77498.94
3191643-191643101.739101.91
4184539-18453997.96898.13
5190635-190635101.204101.37
6190099-190099100.920101.09
15min1179865-17986595.48799.202.2595.8199.532.25
2186199-18619998.84999.18
3190472-190472101.118101.46
4184626-18462698.01498.34
5190638-190638101.206101.54
6189323-189323100.508100.84
20min1180035-18003595.57799.232.1896.0699.732.18
2186037-18603798.76399.26
3190985-190985101.390101.90
4185236-18523698.33898.83
5190183-190183100.964101.47
6189040-189040100.358100.86
30min1179189-17918995.12898.932.3095.7799.592.30
2185486-18548698.47199.13
3190808-190808101.296101.97
4184647-18464798.02598.68
5190259-190259101.005101.68
6187678-18767899.634100.30
45min1177207-17720794.07698.532.5894.8799.362.58
2184381-18438197.88498.71
3189683-189683100.699101.54
4184256-18425697.81898.63
5189521-189521100.613101.45
6188553-188553100.099100.93
极限1178629-17862994.83198.482.0895.7899.472.08
2184990-18499098.20799.19
3188859-188859100.261101.27
4184323-18432397.85398.83
5188263-18826399.945100.95
6187965-18796599.787100.79
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