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DIBSF0200923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%
111.013778673776853774493770113768413773710.12
211.033771233773363772300.04
单位质量响应值RSD%判断
34275.3034200.360.16数据可信
供试品溶液-24090201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%
5min1326707-32670785.53785.271.1985.5485.271.19
2321397-32139784.14784.15
3328903-32890386.11286.11
10min1352100-35210092.18591.380.7792.3391.520.77
2347673-34767391.02691.17
3347293-34729390.92791.07
15min1354313-35431392.76591.860.8793.0692.160.86
2349692-34969291.55591.85
3348618-34861891.27491.57
20min1355037-35503792.95492.040.9393.4192.490.93
2351042-35104291.90892.35
3348615-34861591.27391.72
30min1354909-35490992.92192.031.0593.5392.631.05
2351962-35196292.14992.75
3347596-34759691.00691.61
45min1355614-35561493.10592.031.1993.8792.791.19
2351658-35165892.07092.82
3347258-34725890.91891.67
极限1358236-35823693.79292.911.2794.7193.821.27
2356636-35663693.37394.28
3349774-34977491.57692.48
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DIBSF0200923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%
111.013769853771603775153770293770753771530.06
211.033769423770013769720.02
单位质量响应值RSD%判断
34255.5034176.970.17数据可信
供试品溶液-24090202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%
5min1325168-32516885.18886.321.4085.1986.321.40
2328977-32897786.18686.19
3334348-33434887.59387.59
10min1354043-35404392.75391.661.2692.8991.801.25
2345320-34532090.46790.61
3350202-35020291.74691.89
15min1356138-35613893.30192.001.3893.6092.301.38
2346479-34647990.77191.07
3350953-35095391.94392.24
20min1356620-35662093.42892.081.3493.8892.531.34
2347461-34746191.02891.47
3350323-35032391.77892.23
30min1357398-35739893.63292.041.5694.2492.641.56
2346788-34678890.85291.45
3349792-34979291.63992.24
45min1357178-35717893.57492.041.5094.3492.791.50
2347054-34705490.92291.67
3349678-34967891.60992.37
极限1361332-36133294.66292.721.8495.5893.631.83
2349193-34919391.48292.38
3351233-35123392.01692.93
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DIBSF0200923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%
111.013773753772863775863772013773663773630.04
211.033764473763663764060.02
单位质量响应值RSD%判断
34274.5734125.660.31数据可信
供试品溶液-24090203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%
5min1319575-31957583.76284.811.2383.7684.811.23
2327507-32750785.84185.84
3323641-32364184.82884.83
10min1339418-33941888.96389.511.0489.1089.651.04
2345583-34558390.57990.72
3339486-33948688.98189.12
15min1341670-34167089.55489.810.9989.8490.100.99
2346407-34640790.79591.09
3339857-33985789.07889.37
20min1341593-34159389.53389.871.1089.9790.311.10
2347102-34710290.97791.42
3339944-33994489.10189.54
30min1341286-34128689.45389.791.0090.0490.391.00
2346457-34645790.80891.41
3340027-34002789.12389.71
45min1341540-34154089.52089.821.0490.2690.561.03
2346628-34662890.85391.60
3339840-33984089.07489.81
极限1344691-34469190.34590.491.1691.2391.381.16
2349471-34947191.59892.50
3341574-34157489.52890.41
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DIBSF0200923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%
111.013775673769043771843771083770353771600.07
211.033765323767883766600.05
单位质量响应值RSD%判断
34256.1334148.690.23数据可信
供试品溶液-24090204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%
5min1333700-33370087.45987.841.0587.4687.841.05
2332610-33261087.17387.17
3339130-33913088.88288.88
10min1351837-35183792.21292.170.7092.3692.320.70
2349184-34918491.51791.66
3354052-35405292.79392.94
15min1352936-35293692.50092.220.6592.8092.520.64
2349278-34927891.54191.84
3353393-35339392.62092.92
20min1353214-35321492.57392.130.7693.0392.580.76
2348472-34847291.33091.78
3352873-35287392.48492.94
30min1352191-35219192.30591.970.4992.9192.580.50
2348976-34897691.46292.06
3351606-35160692.15292.76
45min1351075-35107592.01291.820.4192.7792.580.40
2348704-34870491.39192.15
3351199-35119992.04592.81
极限1352452-35245292.37392.190.4693.2993.100.46
2349903-34990391.70592.61
3352873-35287392.48493.40
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