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%
111.283837403833783834763834703828623833850.09
211.223822843824813823820.04
单位质量响应值RSD%判断
33988.0334080.390.20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%
5min1258583-25858368.10668.410.8268.1168.410.82
2262182-26218269.05469.05
3258456-25845668.07368.07
10min1238378-23837862.78563.100.6962.9063.210.70
2241440-24144063.59163.71
3238853-23885362.91063.02
15min1334474-33447488.09587.650.5488.3187.870.54
2332988-33298887.70387.92
3330944-33094487.16587.38
20min1309397-30939781.49081.750.4181.8582.110.41
2311788-31178882.12082.49
3309965-30996581.63982.00
30min1366843-36684396.62095.511.0997.1296.011.08
2361951-36195195.33295.84
3359059-35905994.57095.07
45min1342113-34211390.10789.980.2690.7790.640.26
2342170-34217090.12290.78
3340606-34060689.71090.37
60min1381956-381956100.60199.191.37101.41100.001.36
2376194-37619499.08399.90
3371663-37166397.89098.70
极限1358588-35858894.44694.230.9595.4395.210.94
2360685-36068594.99895.98
3354068-35406893.25594.23
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%
111.283823263822943822683821653824373822980.03
211.223825593822293823940.07
单位质量响应值RSD%判断
33891.6734081.460.40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%
5min1231264-23126460.99761.520.8661.0061.520.86
2233213-23321361.51161.51
3235246-23524662.04762.05
10min1235089-23508962.00659.105.0862.1159.205.08
2212359-21235956.01056.11
3224743-22474359.27759.38
15min1315514-31551483.21883.210.7083.4283.410.70
2313307-31330782.63682.83
3317665-31766583.78583.99
20min1313159-31315982.59780.022.8382.9480.362.82
2297150-29715078.37478.71
3299873-29987379.09379.43
30min1350724-35072492.50592.020.8192.9992.490.82
2345629-34562991.16191.63
3350264-35026492.38392.86
45min1346673-34667391.43688.912.5192.0789.532.50
2330827-33082787.25787.87
3333739-33373988.02588.65
60min1368131-36813197.09696.360.8997.8897.130.90
2361776-36177695.42096.18
3366137-36613796.57097.34
极限1363434-36343495.85793.672.0396.8194.612.02
2350842-35084292.53693.46
3351123-35112392.61093.55
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