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%
111.383855043843973836893842793830973841930.24
211.343839163844053841600.10
单位质量响应值RSD%判断
33760.3733876.540.25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
2024122121批1392924392406392665104.08102.881.50101.27%～104.50%
2393919393058393488104.30
3392468389877391172103.69
4383997383673383835101.74
5387651390499389075103.13
6378866378377378622100.36
2024122121批1398612397822398217105.55103.301.10102.12%～104.49%
2388583388248388416102.95
3388102389095388598103.00
4388200387934388067102.86
5389669388304388986103.11
6386699385568386134102.35
l批1386258384641385450102.17101.721.59100.03%～103.42%
2383224383360383292101.60
3392176392300392238103.97
437570137463337516799.44
5388105386794387450102.70
6378843379113378978100.45
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%
111.383808123822563836903842563842803830590.40
211.343836673853293844980.31
单位质量响应值RSD%判断
33660.7233906.350.52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
2024122121批1378190377655377922100.28100.821.9498.78%～102.86%
237712137611837662099.93
3379415379707379561100.71
4391206390704390955103.74
537000436925336962898.08
6385005385204385104102.18
2024122121批136840836830036835497.74100.493.6796.62%～104.35%
2389642389929389786103.43
335493135529335511294.23
4387266387033387150102.73
5385845385230385538102.30
6386389386162386276102.49
l批1381869380950381410101.20100.790.75100.01%～101.58%
2382094381694381894101.33
3383570382821383196101.68
437520637576937548899.63
5378323378869378596100.46
6378538378641378590100.46
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%
111.383816253821803833263823573831663825310.19
211.343857393862253859820.09
单位质量响应值RSD%判断
33614.3234037.210.89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
2024122121批137735537679437707499.9399.642.5696.97%～102.31%
2389409388990389200103.14
335891136020035955695.29
437493237495437494399.37
5379927379570379748100.64
637555137504037529699.46
2024122121批136328436352936340696.3197.772.1695.56%～99.98%
2377391378972378182100.22
336092036287436189795.91
437188037044237116198.36
5378407377457377932100.16
636036236152236094295.66
l批136677036640336658697.15101.914.4397.18%～106.64%
237608437697637653099.79
3383689383847383768101.70
437588037619537603899.66
5415420415916415668110.16
6388983388510388746103.02
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