比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.203825383834723799913795093804403811900.46
211.253810773800753805760.19
单位质量响应值RSD%判断
34034.8233828.980.43数据可信
影响因素30天-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024121821批1386153385312385732101.90101.741.07100.59%～102.88%
2384457384584384520101.58
3388450388647388548102.65
4380756381016380886100.62
5390728390527390628103.20
6379926380614380270100.46
2024121821批1387960387700387830102.46101.120.94100.13%～102.11%
237787037815537801299.86
3381008381726381367100.75
4380150381147380648100.56
5382698383153382926101.16
6386020385611385816101.92
l批1383710384703384206101.50100.990.81100.14%～101.84%
2379428379716379572100.27
3378815379119378967100.11
4382321382056382188100.97
5381491381547381519100.79
6387183387322387252102.30
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.203794413791823796363795903793933794480.05
211.253803413807023805220.07
单位质量响应值RSD%判断
33879.2933824.180.12数据可信
影响因素30天-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024121821批137424937448937436999.13100.921.2199.65%～102.20%
2380012379734379873100.59
3384080383847383964101.67
4381888384550383219101.48
5387483386939387211102.53
6378365378017378191100.15
2024121821批1380940380270380605100.78100.560.9799.55%～101.58%
2379814380106379960100.61
337555837518837537399.40
4385803385633385718102.14
537604337692437648499.69
6380397380735380566100.77
l批137378837387937383498.9999.920.8199.07%～100.76%
2378161378730378446100.21
3382066381819381942101.14
437416937450837433899.13
537613337697737655599.71
6378653378981378817100.31
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6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%
111.203778123773653779243776773777583777070.06
211.253775643776603776120.02
单位质量响应值RSD%判断
33723.8433565.510.34数据可信
影响因素30天-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024121821批137284637270237277499.3299.162.0597.04%～101.28%
2383292383688383490102.17
336353536316236334896.81
436541936470236506097.26
5378072377249377660100.62
637126137020837073498.78
2024121821批136929637028736979298.52100.591.7198.78%～102.39%
237199837148537174299.04
3387747387108387428103.22
4380642380039380340101.34
5379840380056379948101.23
6376223375719375971100.17
l批137082737084737083798.8099.241.3897.81%～100.66%
237167637208337188099.08
337533537493737513699.95
436343436354636349096.85
5377789378364378076100.73
6375198375544375371100.01
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