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%
119.299704996897968869715797120970220.13
219.359709796880969880.16
单位质量响应值RSD%判断
5029.655012.300.25数据可信
长期9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
20240301211100511100719100615102.36101.371.7099.57%～103.17%
2102076102023102050103.82
3989539912499038100.76
4100380100349100364102.11
597332975499744099.13
6983249835398338100.04
2024030221196559964479650398.18100.681.6198.99%～102.38%
210025299916100084101.82
3990629898299022100.74
4100428100465100446102.19
597603976599763199.32
6100112100109100110101.85
2024030321195111949389502496.67100.001.9098.01%～102.00%
298149982199818499.89
397855980839796999.67
4100751100585100668102.41
5990199890298960100.68
6990499893998994100.71
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%
119.291937671936851936301938261936191937050.05
219.351936061938741937400.10
单位质量响应值RSD%判断
10041.7310012.400.21数据可信
长期9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
20240301211198322198241198282101.01101.250.83100.37%～102.13%
2197580197842197711100.72
3198920198770198845101.30
4201988201677201832102.82
5197089197102197096100.41
6198537198899198718101.23
20240302211196385196903196644100.1899.951.2598.64%～101.26%
219470719464319467599.17
3198656198830198743101.25
4198818198760198789101.27
519248019243619245898.04
619556119612919584599.77
2024030321119305719308619307298.36100.191.0899.05%～101.32%
2199370199755199562101.66
319604319607819606099.88
4197517197436197476100.60
5197161197193197177100.45
6196787196516196652100.18
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%
119.299688596850968949695097053969260.09
219.359773897687977120.04
单位质量响应值RSD%判断
5024.685049.720.36数据可信
中间条件9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
2024030121197329974469738898.76100.891.3599.47%～102.32%
2100884101019100952102.37
3990519897099010100.40
4988879872698806100.20
5100890100290100590102.01
6100196100210100203101.61
2024030221197783979869788499.2699.770.7199.04%～100.51%
2994669945799462100.86
397783975379766099.03
497896979499792299.30
598532986729860299.99
6987069888798796100.19
2024030321199860100307100084101.49100.391.1999.14%～101.64%
298296983659833099.71
398641983259848399.87
4100583100764100674102.09
597504975269751598.89
6987499904298896100.29
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%
119.291926631926241925721924951925391925790.04
219.351922131923331922730.05
单位质量响应值RSD%判断
9983.369936.590.34数据可信
中间条件9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
20240301211196524196708196616100.84100.001.5898.34%～101.65%
2195520195443195482100.26
3198199199018198608101.86
419395119398719396999.48
5195783195415195599100.32
618959418950218954897.21
20240302211195769195657195713100.37100.251.2698.93%～101.57%
2194943195090195016100.02
319322619307819315299.06
4198626199278198952102.04
519234119278519256398.76
6197462197400197431101.26
2024030321119409719417419413699.5798.970.7398.22%～99.72%
219400919385519393299.46
319189919215819202898.48
419455419457019456299.78
519190019200619195398.45
619127419123619125598.09
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