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%
110.101671451663191663951672341670391668260.27
210.051669001672681670840.16
单位质量响应值RSD%判断
16517.4316625.270.47数据可信
供试品溶液-2025120221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189258-189258102.583100.411.59102.58100.411.59
2188553-188553102.201102.20
3182157-18215798.73498.73
4183211-18321199.30599.31
5184465-18446599.98599.98
6183893-18389399.67599.67
10min1191160-191160103.614101.531.70103.78101.691.70
2191114-191114103.589103.76
3183639-18363999.53799.70
4184786-184786100.159100.32
5186640-186640101.164101.33
6186523-186523101.100101.27
15min1190947-190947103.498101.361.59103.84101.691.59
2190239-190239103.114103.46
3183658-18365899.54799.88
4185044-185044100.299100.63
5185353-185353100.466100.80
6186733-186733101.214101.55
20min1191132-191132103.598101.381.63104.11101.881.63
2189971-189971102.969103.48
3183151-18315199.27399.77
4184667-184667100.094100.59
5186455-186455101.063101.57
6186820-186820101.261101.76
30min1190409-190409103.207101.211.54103.90101.881.54
2189734-189734102.841103.53
3183057-18305799.22299.88
4184561-184561100.037100.70
5186342-186342101.002101.67
6186261-186261100.958101.63
45min1190913-190913103.480101.401.60104.34102.241.60
2190146-190146103.064103.92
3183326-18332699.367100.19
4184758-184758100.144100.98
5186132-186132100.888101.73
6187140-187140101.435102.28
极限1190426-190426103.216101.031.62104.25102.041.62
2189679-189679102.811103.84
3182932-18293299.154100.15
4184125-18412599.800100.80
5185375-185375100.478101.49
6185832-185832100.726101.74
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%
110.101665701664681660731665241661831663640.14
210.051674481674231674360.02
单位质量响应值RSD%判断
16471.6816660.300.81数据可信
供试品溶液-2025120321批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1191683-191683103.933101.701.62103.93101.701.62
2183140-18314099.30199.30
3188253-188253102.073102.07
4189793-189793102.908102.91
5185695-185695100.686100.69
6186874-186874101.325101.33
10min1192569-192569104.413102.241.47104.59102.411.47
2184439-184439100.005100.17
3189224-189224102.600102.77
4190103-190103103.076103.25
5187765-187765101.809101.98
6187279-187279101.545101.71
15min1192356-192356104.298102.121.44104.65102.461.45
2184413-18441399.991100.32
3189338-189338102.661103.00
4189555-189555102.779103.12
5187327-187327101.571101.91
6187050-187050101.421101.76
20min1192358-192358104.299102.371.33104.82102.881.33
2185009-185009100.314100.81
3189279-189279102.629103.14
4190327-190327103.198103.71
5187829-187829101.843102.35
6187949-187949101.908102.42
30min1192404-192404104.324102.281.38105.02102.961.38
2184589-184589100.087100.75
3189362-189362102.674103.36
4189797-189797102.910103.60
5187940-187940101.903102.58
6187732-187732101.791102.47
45min1192495-192495104.373101.971.52105.24102.821.52
2184026-18402699.781100.61
3188267-188267102.081102.94
4189568-189568102.786103.64
5187218-187218101.512102.36
6186793-186793101.282102.13
极限1191838-191838104.017101.771.42105.06102.791.42
2184093-18409399.818100.82
3188452-188452102.181103.21
4188802-188802102.371103.40
5186680-186680101.220102.24
6186248-186248100.986102.00
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%
110.101673711674691673501668881677761673710.20
210.051663931659101661520.21
单位质量响应值RSD%判断
16571.3916532.540.17数据可信
供试品溶液-2025120421批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195492-195492106.085102.781.73106.08102.781.73
2187342-187342101.662101.66
3190268-190268103.250103.25
4186467-186467101.187101.19
5187752-187752101.885101.88
6189057-189057102.593102.59
10min1190752-190752103.513103.180.59103.69103.340.59
2189459-189459102.811102.98
3192039-192039104.211104.38
4189186-189186102.663102.83
5189235-189235102.689102.86
6190108-190108103.163103.33
15min1190382-190382103.312103.030.85103.66103.370.85
2189727-189727102.956103.30
3192709-192709104.575104.92
4187932-187932101.982102.32
5189317-189317102.734103.07
6189096-189096102.614102.96
20min1190545-190545103.400102.920.78103.92103.440.78
2189196-189196102.668103.18
3192166-192166104.280104.80
4188216-188216102.136102.65
5188516-188516102.299102.81
6189327-189327102.739103.25
30min1190145-190145103.183102.790.88103.88103.480.88
2188865-188865102.489103.17
3192402-192402104.408105.10
4187823-187823101.923102.60
5188263-188263102.162102.84
6189075-189075102.603103.29
45min1189095-189095102.613102.440.94103.48103.300.94
2188090-188090102.068102.92
3191950-191950104.163105.03
4186729-186729101.330102.18
5187948-187948101.991102.84
6188821-188821102.465103.32
极限1188714-188714102.407102.100.88103.44103.120.88
2187701-187701101.857102.88
3191052-191052103.675104.72
4186206-186206101.046102.06
5187390-187390101.688102.71
6187812-187812101.917102.94
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%
110.101657601658571663371660351652651658510.24
210.051665061660261662660.21
单位质量响应值RSD%判断
16420.8916543.880.53数据可信
供试品溶液-G01T79批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146750-14675079.97283.1212.2579.9783.1212.25
2158025-15802586.11686.12
3151504-15150482.56382.56
4131567-13156771.69871.70
5185934-185934101.325101.33
6141380-14138077.04577.05
10min1171755-17175593.59896.056.0393.7396.196.05
2181469-18146998.89299.04
3175379-17537995.57395.71
4165190-16519090.02190.14
5194731-194731106.119106.29
6168997-16899792.09592.22
15min1179556-17955697.850100.053.9298.14100.353.94
2184116-184116100.335100.64
3182662-18266299.54299.84
4177443-17744396.69896.97
5197466-197466107.610107.96
6180321-18032198.26698.55
20min1183438-18343899.965101.132.99100.42101.593.00
2184077-184077100.313100.79
3183440-18344099.966100.43
4181757-18175799.04999.48
5196738-196738107.213107.74
6183959-183959100.249100.69
30min1185978-185978101.349101.672.85101.97102.302.86
2183815-183815100.171100.81
3183348-18334899.916100.55
4183814-183814100.170100.77
5197210-197210107.470108.17
6185223-185223100.938101.55
45min1185780-185780101.241101.612.69102.03102.422.70
2183957-183957100.248101.06
3183339-18333999.911100.71
4184058-184058100.303101.07
5196510-196510107.089107.97
6185145-185145100.895101.68
极限1184997-184997100.815101.402.74101.77102.372.76
2183289-18328999.884100.86
3183288-18328899.883100.85
4183800-183800100.162101.09
5196357-196357107.005108.07
6184661-184661100.632101.58
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