富马酸比索洛尔片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.128255582720828228255382740826780.15
210.158221382134821740.07
单位质量响应值RSD%判断
8169.768095.960.65数据可信
供试品溶液-G01T78批-5mg-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min173010-7301080.63569.6421.9380.6369.6421.93
271554-7155479.02679.03
369115-6911576.33376.33
450644-5064455.93355.93
573118-7311880.75480.75
640872-4087245.14045.14
10min180608-8060889.02680.4418.7289.1680.5618.73
280216-8021688.59388.72
380217-8021788.59488.72
461266-6126667.66467.76
584162-8416292.95193.09
650529-5052955.80655.88
15min183238-8323891.93184.8716.2092.2185.1216.21
284292-8429293.09593.37
383508-8350892.22992.50
466805-6680573.78273.99
587055-8705596.14696.44
656152-5615262.01662.18
20min185715-8571594.66688.2313.5795.1088.6213.60
287031-8703196.12096.55
385571-8557194.50794.94
470942-7094278.35178.68
588133-8813397.33797.79
661936-6193668.40468.68
30min188741-8874198.00892.6110.0998.6093.1510.13
290534-9053499.989100.58
387368-8736896.49297.08
476741-7674184.75585.21
589739-8973999.11199.72
670016-7001677.32877.71
45min190801-90801100.28395.867.22101.0496.557.28
292441-92441102.095102.86
388288-8828897.50898.25
481948-8194890.50691.11
590809-90809100.292101.07
676486-7648684.47484.99
极限192294-92294101.932101.061.71102.86101.911.72
293504-93504103.269104.20
388981-8898198.27399.18
492123-92123101.744102.50
591484-91484101.038101.98
690611-90611100.074100.73
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.128270482558827088286882691827060.14
210.158288182731828060.13
单位质量响应值RSD%判断
8172.538158.230.13数据可信
供试品溶液-G01T78批-5mg-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min164852-6485271.33876.316.7471.3476.306.73
277229-7722984.95384.95
366879-6687973.56873.57
465664-6566472.23172.23
569593-6959376.55376.55
671992-7199279.19279.19
10min178146-7814685.96187.274.5086.0887.404.50
284106-8410692.51892.66
374693-7469382.16382.29
477416-7741685.15885.28
578623-7862386.48686.61
683040-8304091.34591.48
15min183962-8396292.35991.823.4792.6292.093.47
285927-8592794.52194.82
378724-7872486.59786.86
482187-8218790.40790.67
583198-8319891.51991.79
686821-8682195.50495.79
20min188126-8812696.94094.423.1497.3694.843.14
287415-8741596.15796.61
381204-8120489.32589.73
484740-8474093.21593.63
585342-8534293.87794.30
688181-8818197.00097.44
30min191947-91947101.14397.243.01101.7297.823.01
289398-8939898.33998.95
384137-8413792.55293.10
487356-8735696.09396.66
587732-8773296.50697.09
689801-8980198.78299.39
45min194214-94214103.63698.753.10104.3899.493.09
291273-91273100.401101.18
386400-8640095.04195.75
488335-8833597.16997.90
588095-8809596.90597.65
690302-9030299.333100.10
极限195195-95195104.71699.873.21105.63100.783.20
293364-93364102.701103.65
388820-8882097.70398.57
488024-8802496.82797.72
588616-8861697.47998.38
690718-9071899.791100.73
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