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4000
标示量(mg)2.5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%
110.421724951730721724961729041724621726860.17
210.351729291731311730300.09
单位质量响应值RSD%判断
16572.5516717.870.62数据可信
供试品溶液-G01T7A批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1160076-16007686.38187.525.6086.3887.525.60
2174114-17411493.95693.96
3166427-16642789.80889.81
4152117-15211782.08682.09
5151927-15192781.98481.98
6168514-16851490.93490.93
10min1175143-17514394.51296.461.7994.6696.601.79
2180853-18085397.59397.75
3181523-18152397.95498.10
4176273-17627395.12195.26
5176293-17629395.13295.27
6182421-18242198.43998.59
15min1175923-17592394.93296.871.5995.2397.171.59
2180069-18006997.17097.49
3181232-18123297.79798.11
4176865-17686595.44195.74
5179308-17930896.75997.05
6183660-18366099.10899.42
20min1175736-17573694.83296.801.6295.2997.271.62
2180092-18009297.18297.66
3181160-18116097.75898.23
4176374-17637495.17695.63
5179564-17956496.89797.35
6183387-18338798.96099.44
30min1174806-17480694.33096.371.5394.9597.001.54
2179454-17945496.83897.48
3180221-18022197.25297.89
4175957-17595794.95195.56
5178969-17896996.57697.19
6182127-18212798.28098.93
45min1174408-17440894.11596.081.6094.8996.871.60
2178938-17893896.55997.36
3179462-17946296.84297.64
4175181-17518194.53295.30
5178255-17825596.19196.97
6182049-18204998.23899.05
极限1173206-17320693.46695.521.6494.4096.471.65
2177329-17732995.69196.66
3178300-17830096.21597.18
4174570-17457094.20295.13
5177177-17717795.60996.55
6181465-18146597.92398.90
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4000
标示量(mg)2.5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%
110.421728901727811726951724141724861726530.12
210.351733361730971732160.10
单位质量响应值RSD%判断
16569.3916735.850.71数据可信
供试品溶液-G01T7A批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1161360-16136087.03683.024.7887.0483.024.78
2153684-15368482.89582.90
3162019-16201987.39187.39
4147749-14774979.69479.69
5155203-15520383.71583.71
6143489-14348977.39677.40
10min1180464-18046497.34095.011.8697.4995.141.87
2176972-17697295.45795.59
3179355-17935596.74296.89
4173419-17341993.54093.67
5173587-17358793.63193.77
6173017-17301793.32393.45
15min1183596-18359699.03096.851.6199.3497.141.61
2181642-18164297.97698.27
3180201-18020197.19897.51
4178571-17857196.31996.61
5175547-17554794.68894.98
6177756-17775695.87996.16
20min1183634-18363499.05096.901.6399.5297.351.63
2182172-18217298.26198.72
3179830-17983096.99897.47
4178988-17898896.54496.99
5175818-17581894.83495.29
6177392-17739295.68396.13
30min1182962-18296298.68896.631.5399.3297.251.53
2181408-18140897.84998.47
3179206-17920696.66297.29
4178652-17865296.36396.97
5175375-17537594.59595.21
6177326-17732695.64896.25
45min1182297-18229798.32996.161.6399.1396.941.63
2180948-18094897.60198.39
3178196-17819696.11796.91
4177356-17735695.66496.43
5174569-17456994.16094.93
6176244-17624495.06495.83
极限1182202-18220298.27895.691.7899.2496.631.78
2179808-17980896.98697.94
3177010-17701095.47796.43
4176535-17653595.22196.15
5173348-17334893.50294.43
6175523-17552394.67595.60
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4000
标示量(mg)2.5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%
110.421729661725781726771729351729181728150.11
210.351731351729281730320.09
单位质量响应值RSD%判断
16584.9316718.070.57数据可信
供试品溶液-G01T78批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1139825-13982575.42479.377.3575.4279.377.35
2146626-14662679.09379.09
3132083-13208371.24871.25
4153947-15394783.04283.04
5147215-14721579.41179.41
6163189-16318988.02788.03
10min1169274-16927491.31092.884.1391.4493.014.13
2181351-18135197.82497.96
3164434-16443488.69988.82
4169114-16911491.22391.36
5168162-16816290.71090.84
6180776-18077697.51497.66
15min1177155-17715595.56195.763.9795.8496.043.97
2188092-188092101.460101.76
3173349-17334993.50893.77
4170543-17054391.99492.28
5172102-17210292.83593.12
6183850-18385099.17299.48
20min1179338-17933896.73896.053.9997.1896.503.99
2189095-189095102.002102.47
3173814-17381493.75994.18
4170816-17081692.14192.59
5172311-17231192.94893.39
6183050-18305098.74199.22
30min1179106-17910696.61395.814.1497.2196.424.13
2188802-188802101.843102.48
3173408-17340893.54094.12
4169724-16972491.55292.15
5171778-17177892.66093.25
6182891-18289198.65599.29
45min1178231-17823196.14195.414.3196.9096.184.30
2188272-188272101.558102.36
3173245-17324593.45294.19
4169283-16928391.31592.06
5169574-16957491.47292.22
6182692-18269298.54899.35
极限1177618-17761895.81195.023.9996.7395.943.98
2186620-186620100.666101.64
3172208-17220892.89293.78
4168350-16835090.81191.71
5170678-17067892.06792.97
6181418-18141897.86098.83
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4000
标示量(mg)2.5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%
110.421726051724391728071726531724441725900.09
210.351728371731741730060.14
单位质量响应值RSD%判断
16563.3416715.560.65数据可信
供试品溶液-G01T78批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1153487-15348782.85475.8615.6582.8575.8615.64
2115383-11538362.28562.29
3159264-15926485.97385.97
4128559-12855969.39869.40
5119692-11969264.61164.61
6166751-16675190.01490.01
10min1178953-17895396.60190.4210.3596.7490.5610.36
2148795-14879580.32180.43
3187497-187497101.213101.36
4153535-15353582.88083.00
5153552-15355282.88983.00
6182741-18274198.64698.80
15min1182749-18274998.65094.106.8898.9594.376.90
2161999-16199987.44987.69
3188757-188757101.893102.21
4163577-16357788.30188.55
5165129-16512989.13989.38
6183670-18367099.14799.46
20min1183455-18345599.03195.525.3399.4995.965.35
2168793-16879391.11791.50
3188587-188587101.802102.28
4166882-16688290.08590.49
5169994-16999491.76592.16
6184013-18401399.33399.81
30min1183145-18314598.86496.573.8799.4997.163.90
2175096-17509694.51995.05
3187779-187779101.366102.02
4170123-17012391.83592.39
5173604-17360493.71494.26
6183653-18365399.13899.78
45min1181194-18119497.81196.473.4198.6097.223.44
2177823-17782395.99196.68
3186902-186902100.892101.71
4170663-17066392.12692.83
5173112-17311293.44894.15
6182568-18256898.55399.36
极限1181086-18108697.75396.223.3598.7197.143.38
2177824-17782495.99296.84
3186179-186179100.502101.49
4170420-17042091.99592.85
5172416-17241693.07293.93
6181583-18158398.02199.00
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