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%
110.911862271860271865511868061861991863620.17
210.791862521869741866130.28
单位质量响应值RSD%判断
17081.7617295.000.88数据可信
供试品溶液-3128批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1111613-11161358.21057.282.9958.2157.282.99
2106045-10604555.30655.31
3111832-11183258.32458.32
10min1151112-15111278.81076.732.7878.9176.832.79
2142946-14294674.55174.64
3147311-14731176.82876.93
15min1167943-16794387.58885.002.7987.8285.222.79
2159050-15905082.95083.17
3161929-16192984.45284.68
20min1174587-17458791.05389.461.6191.4389.831.61
2170789-17078989.07289.43
3169237-16923788.26388.63
30min1180426-18042694.09991.372.6294.6291.882.61
2171900-17190089.65290.16
3173251-17325190.35790.87
45min1183092-18309295.48992.632.7396.1793.292.73
2173905-17390590.69891.35
3175822-17582291.69792.36
60min1183543-18354395.72493.002.5496.5793.832.54
2175793-17579391.68292.49
3175638-17563891.60192.42
极限1192243-192243100.26294.844.95101.2695.824.92
2176728-17672892.17093.13
3176586-17658692.09693.07
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%
110.911862081859781860541866371862911862340.14
210.791866091865921866000.01
单位质量响应值RSD%判断
17070.0317293.790.93数据可信
供试品溶液-3208批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1112421-11242158.65458.645.4458.6558.645.45
2118480-11848061.81561.82
3106269-10626955.44455.44
10min1145507-14550775.91676.795.0176.0176.895.01
2155257-15525781.00381.11
3140806-14080673.46373.56
15min1160639-16063983.81185.854.9184.0486.084.91
2173828-17382890.69290.93
3159164-15916483.04183.26
20min1168803-16880388.07090.975.6888.4391.345.68
2185793-18579396.93497.32
3168501-16850187.91388.27
30min1178539-17853993.15095.124.0593.6695.644.06
2190829-19082999.562100.11
3177598-17759892.65993.16
45min1176976-17697692.33496.464.8593.0097.144.85
2194626-194626101.543102.26
3183072-18307295.51596.17
60min1178245-17824592.99697.354.7793.8298.204.76
2195943-195943102.230103.12
3185601-18560196.83497.65
极限1180722-18072294.28998.094.4895.2699.094.48
2197212-197212102.892103.95
3186064-18606497.07698.05
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