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 11.073736573742823736563739563736413738380.08
2 11.093750463738253744360.24
单位质量响应值RSD%判断
33770.3733763.390.02数据可信
供试品溶液-4A84A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%
5min1219502-21950258.27158.814.3458.2758.814.34
2220289-22028958.48058.48
3204156-20415654.19754.20
4225559-22555959.87959.88
5230184-23018461.10661.11
6229440-22944060.90960.91
10min1309674-30967482.20881.581.7382.3181.681.74
2306132-30613281.26881.37
3298684-29868479.29179.38
4306902-30690281.47281.57
5307472-30747281.62481.73
6315040-31504083.63383.73
15min1345204-34520491.64091.431.2891.8791.661.28
2340598-34059890.41890.65
3337676-33767689.64289.86
4347332-34733292.20592.44
5346455-34645591.97292.21
6349219-34921992.70692.95
20min1363055-36305596.37996.121.5496.7796.501.54
2355920-35592094.48594.87
3357171-35717194.81795.19
4370244-37024498.28898.68
5359677-35967795.48295.87
6366367-36636797.25897.65
30min1376996-376996100.08099.651.25100.63100.201.25
2368825-36882597.91198.45
3373457-37345799.14199.67
4381289-381289101.220101.77
5372453-37245398.87499.42
6379337-379337100.702101.26
极限1382149-382149101.448100.681.33102.16101.401.33
2371971-37197198.74699.45
3378366-378366100.444101.14
4385276-385276102.278103.00
5375185-37518599.599100.31
6382683-382683101.590102.32
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 11.073750633744653738493745183743433744480.12
2 11.093755743746453751100.18
单位质量响应值RSD%判断
33825.4733824.170.01数据可信
供试品溶液-4A84A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%
5min1233874-23387461.98059.384.2761.9859.384.27
2231899-23189961.45661.46
3223666-22366659.27459.27
4214582-21458256.86756.87
5210722-21072255.84455.84
6229551-22955160.83460.83
10min1305961-30596181.08381.411.5181.1981.501.51
2312619-31261982.84882.95
3307506-30750681.49381.59
4301182-30118279.81779.91
5303522-30352280.43780.53
6312279-31227982.75882.86
15min1337731-33773189.50390.481.3289.7490.711.32
2345641-34564191.59991.84
3339374-33937489.93890.17
4337688-33768889.49289.72
5339663-33966390.01590.24
6348349-34834992.31792.56
20min1352809-35280993.49994.801.2893.8995.181.28
2362417-36241796.04596.44
3354832-35483294.03594.42
4355546-35554694.22494.60
5356412-35641294.45494.83
6364261-36426196.53496.93
30min1365860-36586096.95798.251.3997.5098.801.39
2375694-37569499.564100.12
3365119-36511996.76197.30
4369567-36956797.94098.47
5370406-37040698.16298.70
6377854-377854100.136100.69
极限1367778-36777897.46699.231.5298.1799.931.51
2380265-380265100.775101.49
3368345-36834597.61698.32
4374434-37443499.23099.93
5374580-37458099.26899.97
6381108-381108100.998101.72
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