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%
1 11.053857823858863856633856953855433857140.04
2 11.053851713843823847760.15
单位质量响应值RSD%判断
34906.2434821.360.18数据可信
供试品溶液-2024122121批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1397769-397769102.272100.741.19102.27100.741.19
2388912-38891299.995100.00
3390328-390328100.359100.36
4392832-392832101.003101.00
5395904-395904101.793101.79
6385212-38521299.04499.04
10min1407108-407108104.674102.781.28104.84102.941.28
2393734-393734101.235101.40
3399443-399443102.703102.87
4399862-399862102.811102.98
5403544-403544103.757103.93
6394672-394672101.476101.64
15min1406158-406158104.429102.501.23104.77102.841.23
2393129-393129101.079101.41
3397268-397268102.144102.48
4398879-398879102.558102.90
5402219-402219103.417103.76
6394343-394343101.392101.73
20min1404314-404314103.955102.031.27104.47102.541.27
2391680-391680100.707101.21
3395619-395619101.720102.23
4396161-396161101.859102.37
5401181-401181103.150103.66
6392102-392102100.815101.32
30min1403930-403930103.857102.111.36104.55102.791.36
2391674-391674100.705101.38
3394525-394525101.438102.12
4401738-401738103.293103.97
5399725-399725102.775103.46
6391273-391273100.602101.27
极限1403052-403052103.631101.681.27104.50102.531.27
2390551-390551100.417101.26
3394647-394647101.470102.32
4395499-395499101.689102.54
5399058-399058102.604103.46
6389915-389915100.253101.09
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%
1 11.053849013845773850453849353846203848160.06
2 11.053849183845653847420.07
单位质量响应值RSD%判断
34824.9834818.280.02数据可信
供试品溶液-2024122221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1396557-396557102.084101.781.59102.08101.781.59
2394873-394873101.651101.65
3405512-405512104.389104.39
4387584-38758499.77499.77
5397506-397506102.328102.33
6390265-390265100.464100.46
10min1397962-397962102.446101.890.80102.62102.060.80
2396793-396793102.145102.31
3397432-397432102.309102.48
4391753-391753100.847101.01
5398916-398916102.691102.86
6391899-391899100.885101.05
15min1397232-397232102.258101.820.79102.60102.160.79
2396365-396365102.035102.37
3397362-397362102.291102.64
4391885-391885100.881101.22
5398954-398954102.701103.04
6391481-391481100.777101.11
20min1397088-397088102.221101.710.71102.73102.220.71
2395191-395191101.733102.24
3396377-396377102.038102.55
4391636-391636100.817101.32
5398429-398429102.566103.08
6391939-391939100.895101.40
30min1397078-397078102.218102.391.65102.90103.071.65
2401452-401452103.344104.02
3408352-408352105.121105.81
4391736-391736100.843101.51
5397361-397361102.291102.97
6390523-390523100.531101.20
极限1395309-395309101.763102.551.98102.61103.401.96
2398912-398912102.690103.54
3395480-395480101.807102.67
4412987-412987106.314107.15
5397968-397968102.447103.30
6389501-389501100.268101.11
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%
1 11.053855193854013858973859303851593855810.09
2 11.053856313863863860080.14
单位质量响应值RSD%判断
34894.2134932.850.08数据可信
供试品溶液-2024122321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1391142-391142100.425100.750.84100.43100.740.83
2389687-389687100.052100.05
3397051-397051101.942101.94
4395891-395891101.644101.64
5389412-38941299.98199.98
6391154-391154100.428100.43
10min1395509-395509101.546101.870.85101.71102.040.85
2394968-394968101.408101.57
3401859-401859103.177103.35
4399096-399096102.467102.64
5392260-392260100.712100.88
6397015-397015101.933102.10
15min1395264-395264101.484102.211.16101.82102.551.15
2400256-400256102.765103.10
3400932-400932102.939103.28
4402549-402549103.354103.69
5390184-390184100.179100.51
6399445-399445102.557102.89
20min1394702-394702101.339101.751.02101.84102.261.02
2394498-394498101.287101.79
3402900-402900103.444103.96
4397662-397662102.099102.61
5390957-390957100.378100.88
6397188-397188101.977102.49
30min1394222-394222101.216101.460.89101.89102.130.89
2393106-393106100.929101.61
3400304-400304102.778103.46
4397265-397265101.997102.68
5390154-390154100.172100.84
6395888-395888101.644102.32
极限1400392-400392102.800101.551.02103.64102.401.01
2392777-392777100.845101.69
3399001-399001102.443103.30
4396191-396191101.722102.57
5389524-389524100.010100.85
6395211-395211101.470102.32
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