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%
119.892005132003682005012004912003212004390.05
219.861999292005882002580.24
单位质量响应值RSD%判断
10077.3810083.480.05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
2025042021批119477119481319479298.7197.580.9096.65%～98.50%
219203919173319188697.23
319198919210119204597.32
419375319370619373098.17
519308619306519307697.84
618989318971218980296.18
2025042021批119152219123919138096.9897.660.9496.70%～98.61%
219137319149319143397.01
319324219313119318697.89
419571919536519554299.09
519096919083719090396.74
619362019404419383298.22
11199039199258199148100.9199.860.6499.20%～100.53%
2197942197806197874100.27
319626319670019648299.56
419673219674519673899.69
519563119551219557299.10
619656719672519664699.65
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%
119.892001752001592001792000592002642001670.04
219.861993251997691995470.16
单位质量响应值RSD%判断
10063.7010047.680.12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
2025042021批1197389197619197504100.3399.560.6198.93%～100.20%
219429819567619498799.05
319668419640519654499.84
419648119636619642499.78
519623119636719629999.72
619418419420719419698.65
2025042021批119567019562119564699.3899.321.1098.18%～100.47%
2197762197730197746100.45
319272619287819280297.94
4197986197970197978100.57
519570619555519563099.38
619345319330619338098.23
1119563419590619577099.4599.511.0698.41%～100.62%
219326919323719325398.17
3199120199109199114101.15
419481019453519467298.89
5197566197135197350100.25
619545219498719522099.17
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