氢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250
标示量(mg)40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%
114.343227583226963225283238253230683229750.16
214.283219643225693222660.14
单位质量响应值RSD%判断
22522.6622567.650.15数据可信
长期6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
2024030121138380338041738211098.3596.694.1792.46%～100.92%
237234437203737219095.80
338608938705238657099.50
434765134583034674089.25
5391388389267390328100.46
637590237609137599696.78
2024030221138470038337038403598.8498.492.5595.86%～101.12%
237494837468637481796.47
3389199387855388527100.00
4394018391481392750101.09
536741836705336723694.52
6390266386995388630100.03
2024030321137521737520137520996.5799.081.6597.36%～100.79%
238934238710738822499.92
339027237430438228898.39
438519738521738520799.15
538380438497338438898.94
6392504396106394305101.49
氢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250
标示量(mg)40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%
114.346502966504996514936505366489106503470.15
214.286553966527756540860.29
单位质量响应值RSD%判断
45351.9545804.340.71数据可信
长期6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
2024030121177870978293078082099.4198.525.2493.11%～103.94%
2801301803592802446102.17
378331278481278406299.82
469365769194469280088.21
5787091786859786975100.20
6795152796748795950101.34
2024030221178458378228078343299.7498.292.6095.62%～100.97%
2787886790288789087100.46
378453678438778446299.88
473646473939273792893.95
578174977751777963399.26
675887075642475764796.46
2024030321178444178486878465499.9098.501.3497.12%～99.87%
276539276271076405197.28
378080078311178195699.56
476289577157876723697.68
576057676310176183897.00
678303978069278186699.55
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