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%
111.043811183815593821283804653804973811530.19
211.043816543801973809260.28
单位质量响应值RSD%判断
34524.7334504.170.05数据可信
供试品溶液-24090901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%
5min1313479-31347981.41684.522.7181.4284.522.71
2324849-32484984.36984.37
3322218-32221883.68683.69
4328627-32862785.35085.35
5323187-32318783.93783.94
6340238-34023888.36688.37
10min1367955-36795595.56497.612.0195.7097.752.01
2375680-37568097.57197.71
3371885-37188596.58596.72
4377734-37773498.10498.25
5372159-37215996.65696.80
6389585-389585101.182101.33
15min1378726-37872698.362100.942.1198.66101.252.11
2388918-388918101.009101.31
3385262-385262100.059100.36
4389886-389886101.260101.57
5385875-385875100.218100.52
6403323-403323104.750105.07
20min1383023-38302399.478102.232.2399.94102.702.23
2396070-396070102.866103.34
3389145-389145101.068101.53
4395064-395064102.605103.08
5389750-389750101.225101.69
6408731-408731106.155106.65
30min1384286-38428699.806102.722.32100.43103.362.32
2396256-396256102.915103.56
3392212-392212101.864102.50
4397037-397037103.117103.76
5391559-391559101.695102.33
6411768-411768106.943107.61
45min1384637-38463799.897102.721.99100.69103.531.99
2395929-395929102.830103.64
3391427-391427101.660102.47
4396971-396971103.100103.92
5395383-395383102.688103.49
6408604-408604106.122106.97
极限1384205-38420599.785102.522.00100.74103.502.00
2395257-395257102.655103.64
3394051-394051102.342103.32
4395626-395626102.751103.74
5390963-390963101.540102.52
6408245-408245106.028107.05
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%
111.043814833814143813143815053816403814710.04
211.043820023814153817080.11
单位质量响应值RSD%判断
34553.5334575.000.05数据可信
供试品溶液-24090902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%
5min1256488-25648866.51866.635.4566.5266.635.45
2250669-25066965.00965.01
3273792-27379271.00671.01
4236046-23604661.21761.22
5271214-27121470.33770.34
6253255-25325565.68065.68
10min1332386-33238686.20288.515.6486.3188.625.64
2334718-33471886.80786.92
3365398-36539894.76394.88
4315837-31583781.91082.01
5363036-36303694.15194.27
6336331-33633187.22587.33
15min1369191-36919195.74798.015.3396.0098.275.33
2368125-36812595.47195.72
3404038-404038104.784105.06
4353267-35326791.61791.86
5400859-400859103.960104.23
6372044-37204496.48796.74
20min1387258-387258100.433102.384.80100.85102.804.80
2385956-385956100.095100.51
3418378-418378108.503108.95
4371297-37129796.29396.68
5417328-417328108.231108.68
6388382-388382100.724101.14
30min1400281-400281103.810105.094.56104.39105.684.57
2391817-391817101.615102.19
3428458-428458111.118111.75
4384663-38466399.760100.31
5427461-427461110.859111.49
6398571-398571103.367103.95
45min1406097-406097105.318105.734.37106.07106.504.38
2393571-393571102.070102.82
3429126-429126111.291112.11
4387525-387525100.502101.22
5429310-429310111.339112.15
6400517-400517103.871104.63
极限1406847-406847105.513106.014.16106.44106.954.16
2394630-394630102.345103.26
3429821-429821111.471112.47
4391532-391532101.541102.43
5429368-429368111.354112.35
6400344-400344103.826104.76
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