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%
119.429522195032951659496095124951000.11
219.449512794826949760.23
单位质量响应值RSD%判断
4897.014885.600.17数据可信
中间条件3月-供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211975149761197562101.89100.961.9598.91%～103.02%
294318941229422098.40
3978299802697928102.27
494860949109488599.09
5964479628596366100.64
6990959912399109103.50
2024030221195802956669573499.98100.721.8898.74%～102.70%
2100115100034100074104.51
395330953469533899.56
4961889638996288100.56
595580958099569499.94
695447956059552699.76
2024030321195009949559498299.1999.822.2397.48%～102.15%
2967429652796634100.92
392103919949204896.13
4985189853198524102.89
5959019574295822100.07
695642953029547299.70
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%
119.421919881924301919551923291916901920780.16
219.441921601923641922620.08
单位质量响应值RSD%判断
9890.739890.020.01数据可信
中间条件3月-供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211197168197068197118101.81101.080.56100.49%～101.67%
2194423194656194540100.47
3196841196732196786101.63
4194685194489194587100.50
5195511195177195344100.89
6195830196035195932101.19
2024030221119204519255519230099.32100.111.0898.98%～101.24%
219266319291019278699.57
3197960198046198003102.26
419303019362919333099.85
519318519324819321699.79
619353419320219336899.87
20240303211195339195163195251100.8499.811.0498.73%～100.89%
2194182194312194247100.32
319135719135119135498.83
4195087195038195062100.74
519041119039519040398.34
619299519335219317499.77
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