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4000
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-YBA2147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%
5min182760-8276079.50676.353.7779.5176.353.78
281836-8183678.61878.62
380005-8000576.85976.86
476699-7669973.68373.68
580505-8050577.33977.34
675063-7506372.11172.11
10min1105324-105324101.182101.430.86101.31101.560.86
2106746-106746102.548102.68
3105673-105673101.518101.65
4104388-104388100.283100.41
5106461-106461102.275102.40
6104910-104910100.785100.90
15min1106188-106188102.012102.020.36102.31102.310.37
2106614-106614102.422102.72
3106147-106147101.973102.27
4105685-105685101.529101.82
5106636-106636102.443102.74
6105890-105890101.726102.01
20min1105923-105923101.758101.740.77102.23102.210.77
2107193-107193102.978103.45
3105539-105539101.389101.86
4104861-104861100.737101.20
5106401-106401102.217102.69
6105504-105504101.355101.81
30min1105712-105712101.555101.650.75102.20102.290.76
2106844-106844102.642103.29
3105379-105379101.235101.87
4104730-104730100.612101.24
5106625-106625102.432103.07
6105585-105585101.433102.06
45min1105393-105393101.249101.380.67102.06102.190.67
2106619-106619102.426103.24
3105433-105433101.287102.09
4104545-104545100.434101.23
5105978-105978101.811102.62
6105238-105238101.100101.90
极限1104757-104757100.638100.980.65101.62101.950.65
2106077-106077101.906102.89
3104787-104787100.666101.64
4104177-104177100.080101.04
5105586-105586101.434102.41
6105288-105288101.148102.11
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4000
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%
5min1167542-16754280.92087.3811.2480.9287.3811.24
2163057-16305778.75478.75
3192109-19210992.78592.79
4203550-20355098.31198.31
5158102-15810276.36176.36
6201145-20114597.15097.15
10min1204148-20414898.60099.351.0098.7399.500.99
2208465-208465100.685100.82
3204281-20428198.66498.82
4205155-20515599.08699.25
5208125-208125100.521100.65
6204086-20408698.57098.73
15min1204466-20446698.75499.541.2699.0599.851.24
2209538-209538101.203101.50
3204285-20428598.66698.99
4205173-20517399.09599.42
5209213-209213101.046101.34
6203858-20385898.46098.79
20min1204489-20448998.76599.391.2799.2399.871.26
2209044-209044100.965101.43
3203621-20362198.34698.83
4204879-20487998.95399.45
5209131-209131101.007101.47
6203530-20353098.30298.79
30min1203505-20350598.29099.191.2998.9299.831.27
2208514-208514100.709101.34
3203468-20346898.27298.92
4204923-20492398.97499.63
5208782-208782100.838101.47
6202964-20296498.02898.68
45min1202678-20267897.89098.901.2698.6899.701.25
2208163-208163100.539101.34
3202916-20291698.00598.82
4203938-20393898.49999.32
5207921-207921100.422101.22
6202966-20296698.02998.85
极限1202659-20265997.88198.581.1698.8499.551.15
2207542-207542100.239101.21
3202118-20211897.62098.59
4203442-20344298.25999.25
5206606-20660699.787100.75
6202254-20225497.68598.67
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4000
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%
5min172261-7226135.02934.235.7335.0334.235.73
274142-7414235.94135.94
374040-7404035.89135.89
472064-7206434.93434.93
566754-6675432.35932.36
664462-6446231.24831.25
10min1191422-19142292.79397.823.3992.8597.883.39
2198353-19835396.15396.21
3210335-210335101.961102.02
4208124-208124100.890100.95
5201673-20167397.76297.82
6200903-20090397.38997.44
15min1205011-20501199.380101.551.2599.59101.761.25
2210086-210086101.841102.06
3211948-211948102.743102.97
4210341-210341101.964102.19
5211543-211543102.547102.76
6207957-207957100.809101.02
20min1208554-208554101.098101.650.80101.48102.040.80
2209397-209397101.507101.90
3210912-210912102.241102.64
4210003-210003101.800102.20
5211986-211986102.762103.15
6207301-207301100.491100.87
30min1209352-209352101.485101.540.72102.03102.100.72
2207653-207653100.661101.22
3210507-210507102.045102.62
4209923-209923101.762102.33
5211470-211470102.512103.07
6207853-207853100.758101.31
45min1208277-208277100.964101.320.65101.68102.050.66
2209538-209538101.575102.30
3211340-211340102.448103.19
4208195-208195100.924101.66
5209247-209247101.434102.16
6207517-207517100.595101.31
极限1207015-207015100.352101.110.78101.24102.010.78
2208713-208713101.175102.07
3210119-210119101.857102.77
4208160-208160100.907101.81
5210723-210723102.149103.05
6206742-206742100.220101.11
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