苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.231023141020521024041021421021641022150.14
219.221022991021621022300.10
单位质量响应值RSD%判断
5315.395318.940.05数据可信
供试品溶液-YAB2147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%
5min182760-82760159.011152.713.77159.01152.713.77
281836-81836157.236157.24
380005-80005153.718153.72
476699-76699147.366147.37
580505-80505154.678154.68
675063-75063144.222144.22
10min1105324-105324202.364202.860.86202.63203.120.86
2106746-106746205.097205.36
3105673-105673203.035203.29
4104388-104388200.566200.81
5106461-106461204.549204.81
6104910-104910201.569201.81
15min1106188-106188204.025204.030.36204.63204.630.37
2106614-106614204.843205.45
3106147-106147203.946204.54
4105685-105685203.058203.64
5106636-106636204.885205.48
6105890-105890203.452204.03
20min1105923-105923203.515203.480.77204.46204.410.77
2107193-107193205.956206.90
3105539-105539202.778203.71
4104861-104861201.475202.39
5106401-106401204.434205.37
6105504-105504202.710203.63
30min1105712-105712203.110203.300.75204.39204.580.76
2106844-106844205.285206.57
3105379-105379202.470203.74
4104730-104730201.223202.48
5106625-106625204.864206.15
6105585-105585202.866204.12
45min1105393-105393202.497202.770.67204.12204.380.67
2106619-106619204.853206.48
3105433-105433202.574204.18
4104545-104545200.868202.46
5105978-105978203.621205.24
6105238-105238202.199203.79
极限1104757-104757201.275201.960.65203.23203.900.65
2106077-106077203.811205.78
3104787-104787201.333203.28
4104177-104177200.161202.08
5105586-105586202.868204.83
6105288-105288202.295204.22
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.232028812032382031642033642030862031470.09
219.222034612035482035040.04
单位质量响应值RSD%判断
10564.0710588.140.17数据可信
供试品溶液-2025042021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%
5min1167542-167542161.840174.7611.24161.84174.7611.24
2163057-163057157.508157.51
3192109-192109185.571185.57
4203550-203550196.622196.62
5158102-158102152.721152.72
6201145-201145194.299194.30
10min1204148-204148197.200198.711.00197.47199.000.99
2208465-208465201.370201.63
3204281-204281197.329197.64
4205155-205155198.173198.50
5208125-208125201.042201.30
6204086-204086197.140197.46
15min1204466-204466197.507199.071.26198.11199.701.24
2209538-209538202.407203.00
3204285-204285197.332197.97
4205173-205173198.190198.85
5209213-209213202.093202.68
6203858-203858196.920197.57
20min1204489-204489197.530198.781.27198.46199.731.26
2209044-209044201.929202.86
3203621-203621196.691197.66
4204879-204879197.906198.89
5209131-209131202.014202.94
6203530-203530196.603197.58
30min1203505-203505196.579198.371.29197.84199.661.27
2208514-208514201.418202.69
3203468-203468196.543197.84
4204923-204923197.949199.27
5208782-208782201.676202.94
6202964-202964196.056197.36
45min1202678-202678195.780197.791.26197.36199.411.25
2208163-208163201.078202.69
3202916-202916196.010197.63
4203938-203938196.997198.65
5207921-207921200.845202.44
6202966-202966196.058197.69
极限1202659-202659195.762197.161.16197.67199.101.15
2207542-207542200.479202.42
3202118-202118195.239197.19
4203442-203442196.518198.49
5206606-206606199.574201.51
6202254-202254195.371197.33
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.232029192028622030002028912030682029480.05
219.222023002021332022160.06
单位质量响应值RSD%判断
10553.7210521.120.22数据可信
供试品溶液-YBA2319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%
5min172261-7226170.05868.475.7370.0668.475.73
274142-7414271.88271.88
374040-7404071.78371.78
472064-7206469.86769.87
566754-6675464.71964.72
664462-6446262.49762.50
10min1191422-191422185.586195.653.39185.70195.763.39
2198353-198353192.306192.43
3210335-210335203.923204.04
4208124-208124201.779201.90
5201673-201673195.525195.63
6200903-200903194.778194.88
15min1205011-205011198.761203.091.25199.19203.541.25
2210086-210086203.681204.12
3211948-211948205.486205.95
4210341-210341203.928204.38
5211543-211543205.094205.53
6207957-207957201.617202.05
20min1208554-208554202.196203.300.80202.95204.080.80
2209397-209397203.013203.79
3210912-210912204.482205.28
4210003-210003203.601204.39
5211986-211986205.523206.30
6207301-207301200.981201.75
30min1209352-209352202.970203.070.72204.06204.190.72
2207653-207653201.322202.44
3210507-210507204.089205.23
4209923-209923203.523204.66
5211470-211470205.023206.14
6207853-207853201.516202.62
45min1208277-208277201.927202.650.65203.36204.100.66
2209538-209538203.150204.60
3211340-211340204.897206.38
4208195-208195201.848203.32
5209247-209247202.868204.33
6207517-207517201.191202.63
极限1207015-207015200.704202.220.78202.47204.010.78
2208713-208713202.350204.14
3210119-210119203.713205.54
4208160-208160201.814203.62
5210723-210723204.299206.10
6206742-206742200.439202.21
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