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%
119.412053842044922043152046712042962046320.22
219.452051152050652050900.02
单位质量响应值RSD%判断
10542.6110544.470.02数据可信
中间条件6月-供试品溶液-2025042021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%
5min1199508-19950896.65696.655.3296.6696.655.32
2208244-208244100.889100.89
3203474-20347498.57898.58
4203479-20347998.58098.58
5178595-17859586.52586.52
6203635-20363598.65698.66
10min1207555-207555100.555101.030.89100.72101.190.89
2211650-211650102.539102.71
3206599-206599100.092100.26
4207183-207183100.375100.54
5208783-208783101.150101.29
6209465-209465101.480101.64
15min1207618-207618100.586101.370.79100.91101.700.79
2211525-211525102.478102.82
3208045-208045100.792101.12
4207807-207807100.677101.01
5210534-210534101.998102.31
6209869-209869101.676102.01
20min1207609-207609100.581101.130.91101.08101.620.91
2211171-211171102.307102.82
3206466-206466100.027100.53
4207361-207361100.461100.96
5210601-210601102.031102.51
6209199-209199101.352101.85
30min1207290-207290100.427100.960.76101.09101.620.76
2210592-210592102.026102.71
3206648-206648100.116100.78
4207354-207354100.458101.12
5209877-209877101.680102.33
6208535-208535101.030101.70
45min1207087-207087100.328100.711.01101.16101.541.00
2210276-210276101.873102.72
3205138-20513899.384100.22
4206856-206856100.216101.05
5210481-210481101.973102.79
6207402-207402100.481101.32
极限1206276-20627699.935100.410.95100.93101.410.95
2210103-210103101.789102.81
3205192-20519299.410100.41
4205612-20561299.614100.61
5209083-209083101.295102.29
6207232-207232100.399101.41
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%
119.412058882054412058812060482060252058570.12
219.452049682058072053880.29
单位质量响应值RSD%判断
10605.7210559.790.31数据可信
中间条件6月-供试品溶液-2025042121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%
5min1203882-20388298.41097.811.6598.4197.821.65
2198119-19811995.62895.63
3205396-20539699.14199.14
4199354-19935496.22496.22
5206555-20655599.70099.70
6202588-20258897.78597.79
10min1207504-207504100.158100.381.22100.32100.541.22
2204657-20465798.78498.94
3212430-212430102.536102.70
4207196-207196100.010100.17
5207828-207828100.315100.48
6208110-208110100.451100.61
15min1207103-20710399.965100.431.17100.30100.761.17
2204743-20474398.82699.15
3212162-212162102.407102.74
4207380-207380100.098100.43
5208394-208394100.588100.92
6208577-208577100.676101.01
20min1205693-20569399.284100.121.2099.78100.621.20
2204118-20411898.52499.01
3211172-211172101.929102.44
4206714-20671499.777100.27
5208346-208346100.565101.07
6208563-208563100.669101.17
30min1206968-20696899.900100.021.14100.56100.691.14
2203763-20376398.35399.01
3211039-211039101.865102.54
4206330-20633099.592100.25
5207456-207456100.135100.80
6207777-207777100.290100.96
45min1206058-20605899.46099.781.37100.29100.611.37
2202119-20211997.55998.38
3210874-210874101.785102.63
4206383-20638399.617100.44
5207484-207484100.149100.98
6207357-207357100.087100.92
极限1205600-20560099.23999.331.11100.23100.331.11
2202066-20206697.53398.51
3209173-209173100.964101.98
4205587-20558799.233100.23
5205867-20586799.368100.37
6206481-20648199.664100.66
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%
119.412048422057422060202063782055812057130.28
219.452045932051922048920.21
单位质量响应值RSD%判断
10598.3010534.290.43数据可信
中间条件6月-供试品溶液-2025042221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%
5min1202232-20223297.76694.926.5197.7794.926.51
2170735-17073582.53982.54
3203344-20334498.30498.30
4204063-20406398.65198.65
5197502-19750295.47995.48
6200187-20018796.77796.78
10min1210302-210302101.667100.342.07101.83100.502.08
2201291-20129197.31197.45
3207837-207837100.476100.64
4213024-213024102.983103.15
5203936-20393698.59098.75
6208991-208991101.034101.19
15min1210809-210809101.913100.722.01102.24101.052.01
2202238-20223897.76998.07
3208161-208161100.632100.96
4213777-213777103.347103.68
5205012-20501299.11099.43
6210091-210091101.565101.90
20min1210688-210688101.854100.472.05102.36100.962.05
2201645-20164597.48297.94
3206966-206966100.055100.55
4213242-213242103.089103.60
5204682-20468298.95099.44
6209743-209743101.397101.90
30min1209991-209991101.517100.322.09102.19100.982.09
2201190-20119097.26297.89
3207681-207681100.400101.07
4213410-213410103.170103.85
5204185-20418598.71099.36
6208686-208686100.886101.55
45min1209733-209733101.392100.101.91102.23100.931.92
2201571-20157197.44798.23
3206761-20676199.956100.79
4212258-212258102.613103.47
5203641-20364198.44799.27
6208404-208404100.750101.59
极限1209218-209218101.14399.821.88102.15100.811.89
2201360-20136097.34598.29
3206690-20669099.921100.92
4211810-211810102.396103.42
5202884-20288498.08199.06
6206868-206868100.007101.01
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%
119.412060512060662058552058092058722059310.06
219.452058332055672057000.10
单位质量响应值RSD%判断
10609.5310575.840.23数据可信
中间条件6月-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%
5min1132080-13208063.69360.0413.5863.6960.0413.58
2100868-10086848.64148.64
3146459-14645970.62770.63
4136985-13698566.05866.06
5113550-11355054.75754.76
6117132-11713256.48456.48
10min1208749-208749100.665100.630.31100.77100.720.33
2207911-207911100.260100.34
3209781-209781101.162101.28
4208770-208770100.675100.78
5208182-208182100.391100.48
6208636-208636100.610100.70
15min1210202-210202101.365101.440.30101.64101.700.31
2210972-210972101.737101.98
3211190-211190101.842102.13
4209643-209643101.096101.37
5209740-209740101.142101.40
6210342-210342101.433101.69
20min1211203-211203101.848101.750.38102.29102.180.37
2212432-212432102.441102.86
3210970-210970101.736102.19
4210386-210386101.454101.90
5210661-210661101.587102.01
6210302-210302101.413101.84
30min1209500-209500101.027101.190.52101.64101.800.52
2211849-211849102.159102.75
3210301-210301101.413102.04
4209064-209064100.816101.43
5208935-208935100.754101.35
6209430-209430100.993101.59
45min1209534-209534101.043101.360.43101.82102.130.42
2211574-211574102.027102.79
3209922-209922101.230102.02
4209169-209169100.867101.65
5210045-210045101.290102.05
6210894-210894101.699102.47
极限1209779-209779101.161101.200.37102.11102.140.37
2210999-210999101.750102.68
3209933-209933101.236102.20
4209056-209056100.813101.76
5208981-208981100.776101.71
6210391-210391101.456102.39
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