非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.381942038194380219417501942245193780319415280.12
210.401973710197268819731990.04
单位质量响应值RSD%判断
187045.09189730.671.01数据可信
加速3月-供试品溶液-pH6.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121119260401923174192460791.9593.421.5291.93%~94.91%
219589571957789195837393.56
319731461972275197271094.25
419143731913014191369491.43
519838021990242198702294.93
619756421976076197585994.40
2024030221119868151987005198691094.9395.311.1594.16%~96.45%
220389382037049203799497.37
320017602001458200160995.63
419830181982625198282294.73
519754301974201197481694.35
619857831984128198495694.83
2024030321120171442019578201836196.4396.691.5595.12%~98.26%
219944231995157199479095.30
320379622036163203706297.32
420452172046439204582897.74
520633082065406206435798.63
619830441981641198234294.71
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.381959939195764419594421957374195501619578830.10
210.401927713193103519293740.13
单位质量响应值RSD%判断
188620.71185516.731.18数据可信
长期3月-供试品溶液-pH6.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121120475962049217204840698.5696.022.5793.44%~98.60%
219959061996822199636496.05
320313642035747203355697.84
419107491911053191090191.94
519638321963728196378094.49
620185842022998202079197.23
2024030221120300352034680203235897.7896.601.7494.84%~98.36%
220340382032967203350297.84
320318732000437201615597.01
419458611943976194491893.58
519915441987651198959895.73
620284062030843202962497.65
2024030321120192772022081202067997.2297.931.7596.14%~99.72%
219964721995349199591096.03
320180402017505201777297.08
420197692020072201992097.19
520706862069593207014099.60
6208665120887732087712100.45
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.383841424384145938408273836761384143138403800.06
210.403937317392106839291920.30
单位质量响应值RSD%判断
369978.81377806.921.49数据可信
加速3月-供试品溶液-pH6.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121141535194149519415151999.9499.511.4198.04%~100.98%
2416651041604174163464100.23
341245784129563412707099.35
440327044041113403690897.18
541097764116760411326899.02
6420732342117264209524101.34
2024030221140240964031114402760596.9698.021.3396.66%~99.38%
241101404107896410901898.92
340214494016331401889096.75
441509284145519414822499.86
540922434103393409781898.65
640262674030631402844996.98
2024030321140138844008723401130496.5797.781.4196.33%~99.23%
240437564046871404531497.39
341145454113912411422899.04
439858223985245398553495.95
540878674081591408472998.33
641309234127090412900699.40
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.383950396395199439451633949950394487339484750.09
210.403874521387303638737780.03
单位质量响应值RSD%判断
380392.58372478.651.49数据可信
长期3月-供试品溶液-pH6.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121141079124108368410814098.2398.120.9297.18%~99.06%
241028594105172410401698.13
341328784126599412973898.75
440842654082980408362297.64
540438914043285404358896.69
641502534153962415210899.28
2024030221140889904091834409041297.8198.190.9297.24%~99.13%
241048034100575410268998.10
340602934053915405710497.01
440931304089113409112297.82
541769114156127416651999.63
641276024131816412970998.75
2024030321140310844040253403566896.5097.431.2296.18%~98.67%
240516184056838405422896.94
340299944032852403142396.40
440867924089039408791697.75
541638834167527416570599.61
640697214074722407222297.37
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