比拉斯汀口腔崩解片项目信息
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%
1 11.073793473797223790923795683788743793210.10
2 11.093798913792553795730.12
单位质量响应值RSD%判断
34265.6734226.600.09数据可信
供试品溶液-3L77C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%
5min1201204-20120452.66653.064.0252.6753.064.02
2209978-20997854.96254.96
3201447-20144752.72952.73
4198641-19864151.99551.99
5191187-19118750.04450.04
6213873-21387355.98255.98
10min1283132-28313274.11074.603.1374.2074.693.13
2292053-29205376.44676.54
3279397-27939773.13373.22
4284465-28446574.45974.55
5273002-27300271.45971.54
6297967-29796777.99478.09
15min1325676-32567685.24685.532.4685.4685.742.46
2333542-33354287.30587.52
3318512-31851283.37183.58
4327391-32739185.69585.91
5317632-31763283.14183.34
6337854-33785488.43488.66
20min1352526-35252692.27491.672.0492.6392.022.04
2355153-35515392.96293.33
3342309-34230989.60089.95
4350024-35002491.62091.97
5341655-34165589.42989.77
6359555-35955594.11494.49
30min1377830-37783098.89897.541.8499.4198.041.84
2376422-37642298.52999.05
3365585-36558595.69396.19
4372190-37219097.42297.93
5363450-36345095.13495.62
6380264-38026499.535100.06
极限1391154-391154102.385100.311.76103.06100.981.76
2384755-384755100.710101.39
3376536-37653698.55999.22
4385104-385104100.802101.47
5373773-37377397.83698.48
6388093-388093101.584102.28
比拉斯汀口腔崩解片项目信息
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%
1 11.073799233804173796233801383804383801080.10
2 11.093805273804743805000.01
单位质量响应值RSD%判断
34336.7734310.190.06数据可信
供试品溶液-3L77C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%
5min1198884-19888451.94150.644.4951.9450.644.49
2202533-20253352.89452.89
3179856-17985646.97246.97
4199324-19932452.05652.06
5186987-18698748.83448.83
6195886-19588651.15851.16
10min1279795-27979573.07272.582.0073.1672.662.01
2280658-28065873.29773.39
3275026-27502671.82671.90
4286192-28619274.74374.83
5270093-27009370.53870.62
6275649-27564971.98972.07
15min1323981-32398184.61283.732.0584.8283.932.06
2321136-32113683.86984.08
3312985-31298581.74081.94
4331503-33150386.57686.79
5317689-31768982.96883.17
6316261-31626182.59582.80
20min1349215-34921591.20289.852.3591.5590.192.35
2342404-34240489.42389.77
3334279-33427987.30187.64
4357283-35728393.30993.66
5339876-33987688.76389.10
6341084-34108489.07889.42
30min1375230-37523097.99698.161.3598.5098.661.35
2374483-37448397.80198.30
3367390-36739095.94896.43
4382692-38269299.945100.46
5378268-37826898.78999.27
6377201-37720198.51199.00
极限1391465-391465102.23699.412.57102.90100.072.57
2371807-37180797.10297.76
3368955-36895596.35797.00
4392593-392593102.531103.21
5379959-37995999.23199.88
6379055-37905598.99599.65
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