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%
111.193753183778333755863774633759843764370.31
211.253752783762453757620.19
单位质量响应值RSD%判断
33640.4833401.070.51数据可信
供试品溶液-24103001批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1215989-21598957.76059.532.6357.7659.532.63
2224847-22484760.12960.13
3227009-22700960.70760.71
10min1191627-19162751.24551.012.1251.3451.112.12
2194255-19425551.94852.05
3186329-18632949.82849.93
15min1276443-27644373.92677.624.3174.1177.814.30
2293581-29358178.50978.70
3300793-30079380.43880.62
20min1260635-26063569.69970.221.3570.0070.531.35
2266657-26665771.30971.63
3260451-26045169.65069.97
30min1297335-29733579.51383.894.8779.9384.324.86
2316236-31623684.56885.00
3327547-32754787.59388.03
45min1287101-28710176.77677.961.3677.3378.541.37
2294624-29462478.78879.37
3292903-29290378.32878.91
60min1306984-30698482.09486.514.6482.7887.214.62
2327139-32713987.48388.19
3336325-33632589.94090.65
极限1304158-30415881.33882.411.3882.1683.261.38
2312588-31258883.59284.45
3307770-30777082.30483.16
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%
111.193751463757863761433757853768793759480.17
211.253773003759583766290.26
单位质量响应值RSD%判断
33596.7833478.130.26数据可信
供试品溶液-3176A批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1211271-21127156.46956.320.5956.4756.320.59
2209283-20928355.93855.94
3211537-21153756.54056.54
10min1181880-18188048.61448.381.4248.7148.481.41
2178134-17813447.61247.71
3183013-18301348.91649.01
15min1272229-27222972.76272.911.1772.9473.091.17
2269927-26992772.14772.32
3276206-27620673.82574.00
20min1255548-25554868.30467.253.5568.6067.553.54
2241404-24140464.52364.82
3257902-25790268.93369.23
30min1299620-29962080.08480.301.5780.4980.711.57
2296203-29620379.17079.57
3305506-30550681.65782.07
45min1290299-29029977.59276.731.9878.1477.271.98
2280522-28052274.97975.51
3290401-29040177.62078.17
60min1311405-31140583.23483.050.2883.9183.720.29
2309749-30974982.79183.45
3310963-31096383.11583.79
极限1310445-31044582.97781.781.8983.7982.591.88
2299468-29946880.04380.84
3307979-30797982.31883.14
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