比拉斯汀片项目信息
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%
110.993760143756033758593769573770983763060.18
211.023783223776863780040.12
单位质量响应值RSD%判断
34240.7634301.630.13数据可信
影响因素10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
2024122121批1400979399638400308104.70101.992.3799.46%～104.52%
2383134381976382555100.06
3402690402565402628105.31
4383360383518383439100.29
5388204388441388322101.57
6382368382351382360100.01
2024122121批1390030390528390279102.08101.500.70100.76%～102.23%
2390847391193391020102.28
3386217387383386800101.17
4389912389136389524101.88
5384678383394384036100.45
6386454386638386546101.11
l批1388519387610388064101.50102.242.5999.47%～105.02%
237873237958537915899.17
3405869405562405716106.12
4394923393665394294103.13
5397408396749397078103.86
638097938131338114699.69
比拉斯汀片项目信息
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%
110.993765673779033775123785023780573777080.20
211.023803353805363804360.04
单位质量响应值RSD%判断
34368.3334522.320.32数据可信
影响因素10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
2024122121批138061338139538100499.15100.100.8099.27%～100.94%
2389369389713389541101.37
3386270385545385908100.43
438348738243138295999.66
5385737385867385802100.40
638258238284538271499.60
2024122121批137768337687237727898.18100.101.5098.53%～101.67%
2388924389073388998101.23
338402138287038344699.79
4391853392310392082102.04
537974737857537916198.67
6386308387581386944100.70
l批1396458395278395868103.02100.441.3399.04%～101.83%
238090838153038121999.21
3385605384878385242100.26
4384704384006384355100.02
538290038392138341099.78
6385472385521385496100.32
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