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)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%
119.569698397033969349707096860969760.09
219.499659796576965860.02
单位质量响应值RSD%判断
4957.874955.670.04数据可信
供试品溶液-2025042322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%
5min197828-97828100.814101.191.24100.81101.191.24
298021-98021101.013101.01
3100572-100572103.642103.64
498098-98098101.092101.09
597232-97232100.200100.20
697397-97397100.370100.37
10min199281-99281102.311102.661.42102.48102.831.42
2100381-100381103.445103.61
3101982-101982105.095105.27
499344-99344102.376102.54
597893-97893100.881101.05
698823-98823101.840102.01
15min199266-99266102.296102.591.35102.63102.931.35
2100445-100445103.511103.85
3101761-101761104.867105.22
499110-99110102.135102.47
598028-98028101.020101.36
698690-98690101.702102.04
20min198760-98760101.775102.191.37102.28102.701.37
2100023-100023103.076103.59
3101461-101461104.558105.08
498636-98636101.647102.16
597736-97736100.719101.22
698347-98347101.349101.86
30min198688-98688101.700101.961.47102.38102.641.47
299884-99884102.933103.62
3101292-101292104.384105.08
498659-98659101.671102.35
597258-97258100.227100.90
697881-97881100.869101.54
45min198523-98523101.530101.671.41102.38102.521.41
299270-99270102.300103.16
3101040-101040104.124105.00
498354-98354101.356102.20
597043-97043100.005100.84
697744-97744100.728101.57
极限198042-98042101.035101.581.43102.05102.601.43
299260-99260102.290103.32
3101024-101024104.108105.15
498358-98358101.360102.38
597168-97168100.134101.14
697552-97552100.530101.54
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)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%
119.569685897268967039667996750968520.26
219.499614296472963070.25
单位质量响应值RSD%判断
4951.534941.350.15数据可信
供试品溶液-2025042322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%
5min195409-9540998.52799.252.3998.5399.252.39
298783-98783102.011102.01
392142-9214295.15395.15
497736-97736100.930100.93
595945-9594599.08099.08
696633-9663399.79199.79
10min196795-9679599.958100.651.97100.12100.821.97
2100139-100139103.411103.58
394565-9456597.65597.81
498922-98922102.154102.32
597080-97080100.252100.42
697299-97299100.478100.64
15min196940-96940100.108100.641.92100.44100.981.92
299535-99535102.787103.13
394364-9436497.44897.77
499263-99263102.507102.85
597241-97241100.419100.75
697401-97401100.584100.92
20min196696-9669699.856100.481.93100.35100.981.93
299588-99588102.842103.36
394310-9431097.39297.88
498983-98983102.217102.73
596983-96983100.152100.65
697251-97251100.429100.93
30min196854-96854100.019100.301.88100.68100.971.88
299438-99438102.687103.37
394121-9412197.19797.84
498530-98530101.750102.43
596894-96894100.060100.73
696919-96919100.086100.75
45min196607-9660799.76499.961.94100.59100.801.95
298958-98958102.192103.05
393674-9367496.73597.54
498518-98518101.737102.59
596383-9638399.532100.37
696639-9663999.797100.63
极限196814-9681499.97899.761.81100.97100.761.81
298578-98578101.799102.83
393464-9346496.51897.49
497760-97760100.954101.97
596359-9635999.508100.51
696630-9663099.788100.79
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)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%
119.569727197010967269712996724969720.26
219.499633296777965540.33
单位质量响应值RSD%判断
4957.674954.030.06数据可信
供试品溶液-2025042421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%
5min193820-9382096.70296.933.7896.7096.943.78
297582-97582100.579100.58
388198-8819890.90790.91
497847-97847100.853100.85
592712-9271295.56095.56
694117-9411797.00897.01
10min195505-9550598.43999.881.7898.60100.041.78
298979-98979102.019102.19
396724-9672499.69599.85
499085-99085102.129102.30
595408-9540898.33998.50
695707-9570798.64798.81
15min195457-9545798.38999.911.8998.71100.241.89
299056-99056102.099102.44
396908-9690899.885100.20
499293-99293102.343102.68
595329-9532998.25798.58
695579-9557998.51598.84
20min195578-9557898.51499.931.7799.00100.421.77
299166-99166102.212102.72
396849-9684999.824100.31
498942-98942101.981102.49
595360-9536098.28998.78
695813-9581398.75699.25
30min194895-9489597.81099.621.7898.46100.281.78
298786-98786101.820102.50
396832-9683299.806100.46
498614-98614101.643102.32
595411-9541198.34298.99
695394-9539498.32498.98
45min195258-9525898.18499.651.8699.00100.471.86
298733-98733101.766102.61
396445-9644599.407100.22
499088-99088102.132102.98
595129-9512998.05198.87
695402-9540298.33299.15
极限194576-9457697.48199.241.8598.46100.231.85
298494-98494101.519102.54
396410-9641099.371100.35
498334-98334101.354102.37
594717-9471797.62698.60
695176-9517698.09999.08
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)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%
119.569759797156971029710697219972360.22
219.499660996804967060.15
单位质量响应值RSD%判断
4971.174961.830.14数据可信
供试品溶液-2025042421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%
5min199892-99892102.740100.201.71102.74100.201.71
298812-98812101.629101.63
395750-9575098.48098.48
495998-9599898.73598.73
597641-97641100.424100.42
696453-9645399.20399.20
10min1101127-101127104.010102.511.34104.18102.681.34
2101565-101565104.460104.63
398933-98933101.753101.92
499133-99133101.959102.12
598933-98933101.753101.92
698330-98330101.133101.30
15min1100841-100841103.716102.401.09104.06102.731.09
2101003-101003103.882104.23
399057-99057101.881102.21
499031-99031101.854102.19
598934-98934101.754102.09
698478-98478101.285101.62
20min1100721-100721103.592102.081.13104.11102.591.13
2100552-100552103.418103.94
399012-99012101.835102.34
498516-98516101.324101.83
598617-98617101.428101.93
698097-98097100.893101.40
30min1100386-100386103.248101.931.06103.94102.601.06
2100359-100359103.220103.91
398829-98829101.646102.32
498532-98532101.341102.01
598685-98685101.498102.17
697822-97822100.611101.28
45min1100282-100282103.141101.911.61104.00102.761.61
2101749-101749104.650105.51
398664-98664101.477102.32
498109-98109100.906101.75
597942-97942100.734101.58
697785-97785100.573101.41
极限1100215-100215103.072101.441.20104.11102.461.20
2100057-100057102.909103.94
398122-98122100.919101.93
497640-97640100.423101.43
597951-97951100.743101.76
697789-97789100.577101.58
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