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%
119.8910021599029991319919299169993470.50
219.8610001499829999220.14
单位质量响应值RSD%判断
4994.825031.320.52数据可信
影响因素5天-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
2025042321批196892968049684898.6899.582.6696.80%～102.35%
296753965239663898.47
3990209920999114100.99
4102176102110102143104.08
597032969819700698.85
694530946699460096.39
2025042321批198037980479804299.90100.721.7298.90%～102.53%
29994910004499996101.89
3100989100964100976102.89
4994309944799438101.32
596174960589611697.94
6984839851098496100.36
YAB2319批1983689842898398100.26100.772.1798.49%～103.06%
2982279810098164100.03
3100715100501100608102.52
495812957299577097.59
5984529854398498100.37
6101939101913101926103.86
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%
119.899991999853999669993099788998910.08
219.869957699487995320.07
单位质量响应值RSD%判断
5022.175011.680.15数据可信
影响因素10天-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
2025042321批197096967939694498.7199.601.3098.25%～100.94%
295913962559608497.83
398026977579789299.67
497800976969774899.52
5997689975199760101.57
6985439841298478100.27
2025042321批1984819841798449100.24100.351.4698.81%～101.88%
2100783100816100800102.63
3988419890998875100.67
497120971299712498.89
5991449923299188100.99
696888969299690898.67
YAB2319批1101481101550101516103.36102.031.49100.44%～103.62%
2995139965699584101.39
3102703102432102568104.43
4988399885498846100.64
5991899906499126100.93
6995539968999621101.43
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%
119.892010462021562015172013252013702014830.21
219.862005222004562004890.03
单位质量响应值RSD%判断
10129.8610095.120.25数据可信
影响因素10天-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
2025042321批1202135202625202380102.23101.081.2099.81%～102.34%
2199393200157199775100.91
3203098202235202666102.37
419546219660519603499.02
5199414200457199936100.99
6199392200214199803100.93
2025042321批1200191200345200268101.16101.411.5299.80%～103.03%
2201366201626201496101.78
3201472201557201514101.79
4204517205626205072103.59
519538219590119564298.82
6200583200667200625101.34
YAB2319批1199685199756199720100.88100.570.45100.10%～101.04%
2199755199841199798100.92
3198547198483198515100.28
4198170198002198086100.06
5200283200071200177101.11
6197633199007198320100.18
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