氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.583283603286913283683279403277493282220.12
214.633278173272333275250.13
单位质量响应值RSD%判断
22511.8022387.220.40数据可信
长期30℃3月--供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20250113211395303394825395064102.1298.152.9495.12%～101.18%
2389493389801389647100.72
336388036399436393794.07
437916837880537898697.96
537536337503837520096.98
637577937510537544297.05
2025011421137117537170337143996.0198.483.2895.10%～101.87%
2387562388054387808100.24
3388661388565388613100.45
4390071390908390490100.93
535996135980835988493.02
6388053387691387872100.26
20250115211393500393901393700101.76101.261.7299.44%～103.08%
2400401401308400854103.61
3388107387997388052100.30
438286038251738268898.92
5397224397140397182102.66
6387912388143388028100.30
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.586633006633056631616630826622796630250.07
214.636599136601676600400.03
单位质量响应值RSD%判断
45474.9745115.520.57数据可信
长期30℃3月--供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20250113211787366786635787000100.8298.771.7796.94%～100.60%
276651376635076643298.19
377791677806677799199.67
477724077694877709499.55
574691174756974724095.73
676953477069377011498.66
20250114211789523788240788882101.0799.061.5197.49%～100.63%
275728875491775610296.87
3783516783212783364100.36
477169677166877168298.86
577139277218277178798.88
676692376803976748198.32
20250115211781020781437781228100.0898.281.3996.85%～99.70%
277798477848877823699.70
376644976652676648898.20
475608375645275626896.89
575710175602775656496.92
676317676456976387297.86
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