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%
119.429607595716959789583995842958900.15
219.449579595601956980.15
单位质量响应值RSD%判断
4937.694922.740.22数据可信
长期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
20240301211967679674296754100.24101.241.3099.86%～102.61%
2976159766297638101.16
395862958909587699.33
4977249803897881101.41
5990359911299074102.65
6990599905299056102.63
20240302211980369833398184101.7399.911.5398.31%～101.51%
2974289743697432100.95
395000947429487198.29
494454944719446297.87
5965799649396536100.02
6970409712797084100.59
2024030321194580946019459098.00100.841.7299.02%～102.65%
2963879667496530100.01
3980769818098128101.67
4970289706897048100.55
5982849835398318101.87
6993149936699340102.92
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%
119.421936571932881932611932981934591933930.09
219.441929411929971929690.03
单位质量响应值RSD%判断
9958.449926.390.23数据可信
长期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
2024030121119298519307519303099.1799.811.6798.06%～101.56%
2195835195665195750100.57
3198320198173198246101.85
4196729197413197071101.25
519036518983019009897.67
619142319149519145998.37
2024030221119442919418819430899.83100.471.2699.14%～101.79%
219266819313319290099.11
3195845195754195800100.60
4197524197782197653101.55
5199084199193199138102.31
619334419361819348199.40
2024030321119270819275219273099.0298.840.4398.39%～99.28%
219165019147219156198.42
319405719334619370299.52
419192319208219200298.64
519175219144719160098.44
619252819279319266098.98
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