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%
119.429676196949966929710697303969620.26
219.449532895327953280.01
单位质量响应值RSD%判断
4992.894903.701.28数据可信
加速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
20240301211977539742497588100.75101.442.2999.01%～103.88%
2981329798198056101.23
3989579913499046102.25
494293942749428497.34
5100523100432100478103.73
699961100293100127103.37
20240302211996829949299587102.8199.512.1097.33%～101.70%
296672967559671499.84
3974609729497377100.53
493718937319372496.76
595126951199512298.20
695848958269583798.94
2024030321194588946769463297.7097.782.5695.16%～100.40%
296278965379640899.53
396563962799642199.54
491499912489137494.33
5973489707697212100.36
692364921249224495.23
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%
119.421920651917591923141925171920211921350.16
219.441914821915341915080.02
单位质量响应值RSD%判断
9893.679851.230.31数据可信
加速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
2024030121119205919199219202699.36100.521.2799.19%～101.85%
2198745198782198764102.84
319249019235519242299.56
4193661193179193420100.08
5195177194902195040100.92
6193939194062194000100.38
20240302211194862195030194946100.87100.871.1399.69%～102.06%
2194033194477194255100.51
3199368199179199274103.11
4193896193899193898100.32
5194015194052194034100.39
6193388193282193335100.03
2024030321119272819271419272199.7299.571.0898.45%～100.69%
2193807193949193878100.31
3193927194111194019100.39
419083519073319078498.71
5194101194162194132100.45
618905118922018913697.86
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