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 10.883806883798513795703791263778103794090.28
2 10.823792773794023793400.03
单位质量响应值RSD%判断
34872.1535059.150.38数据可信
中间条件6月-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%
5min1390742-390742100.17499.720.64100.1799.720.64
2388668-38866899.64299.64
3388532-38853299.60799.61
4384638-38463898.60998.61
5391795-391795100.444100.44
6389565-38956599.87299.87
10min1392991-392991100.750100.070.65100.92100.240.65
2388757-38875799.66599.83
3390797-390797100.188100.35
4386238-38623899.01999.18
5392647-392647100.662100.83
6390641-390641100.148100.31
15min1392191-392191100.54599.900.59100.88100.230.59
2387828-38782899.42799.76
3390242-390242100.045100.38
4386222-38622299.01599.34
5391683-391683100.415100.75
6389812-38981299.935100.27
20min1392258-392258100.56299.760.61101.06100.260.61
2387073-38707399.23399.73
3389707-38970799.908100.41
4385927-38592798.93999.43
5390941-390941100.225100.73
6388775-38877599.669100.17
30min1391071-391071100.25899.940.74100.93100.600.74
2388071-38807199.489100.15
3393385-393385100.851101.52
4385404-38540498.80599.46
5391736-391736100.428101.10
6389204-38920499.779100.45
45min1391299-391299100.31699.590.73101.15100.420.72
2387697-38769799.393100.22
3389710-38971099.909100.74
4383642-38364298.35399.18
5390753-390753100.176101.01
6387678-38767899.388100.22
60min1390190-390190100.03299.400.67101.04100.400.67
2386129-38612998.99199.99
3389185-38918599.774100.78
4383420-38342098.29799.28
5389753-38975399.920100.92
6387682-38768299.389100.39
极限1389379-38937999.82499.090.68101.00100.260.68
2384356-38435698.53699.70
3387289-38728999.288100.46
4382372-38237298.02899.18
5387999-38799999.470100.64
6387727-38772799.401100.56
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 10.883788623787813789993790803786153788670.05
2 10.823806153801733803940.09
单位质量响应值RSD%判断
34822.3335156.560.68数据可信
中间条件6月-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%
5min1380657-38065797.52399.351.3797.5299.351.37
2388711-38871199.58799.59
3387701-38770199.32899.33
4389514-38951499.79299.79
5396162-396162101.496101.50
6383888-38388898.35198.35
10min1385625-38562598.796100.451.2498.96100.621.23
2392861-392861100.650100.82
3391837-391837100.388100.55
4393518-393518100.818100.98
5399897-399897102.453102.62
6388790-38879099.60799.77
15min1382402-38240297.97099.981.1898.30100.321.18
2392056-392056100.444100.78
3389986-38998699.913100.25
4392490-392490100.555100.89
5395921-395921101.434101.77
6388677-38867799.57899.91
20min1380389-38038997.45599.821.5097.95100.321.49
2390823-390823100.128100.63
3389377-38937799.757100.26
4392180-392180100.475100.98
5397913-397913101.944102.45
6387003-38700399.14999.65
30min1381912-38191297.84599.861.2898.50100.521.27
2389953-38995399.905100.57
3389274-38927499.731100.40
4391470-391470100.294100.96
5397289-397289101.784102.46
6388674-38867499.577100.24
45min1382255-38225597.93399.781.1798.75100.621.17
2389800-38980099.866100.70
3388961-38896199.651100.48
4391227-391227100.231101.07
5396217-396217101.510102.36
6388418-38841899.512100.34
60min1381319-38131997.69399.381.3198.67100.381.31
2389943-38994399.902100.90
3387283-38728399.221100.22
4390515-390515100.049101.05
5395065-395065101.215102.23
6383245-38324598.18699.18
极限1380382-38038297.45399.191.1398.59100.351.13
2388194-38819499.454100.62
3386104-38610498.919100.08
4389351-38935199.751100.92
5393401-393401100.788101.97
6385478-38547898.75899.92
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 10.883797713794563793643794503792173794520.06
2 10.823787553782533785040.10
单位质量响应值RSD%判断
34876.1034981.890.22数据可信
中间条件6月-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%
5min1382116-38211698.06599.131.1298.0699.131.12
2391664-391664100.515100.51
3391534-391534100.482100.48
4382451-38245198.15198.15
5384167-38416798.59198.59
6385687-38568798.98198.98
10min1386860-38686099.28299.801.3399.4599.961.33
2397006-397006101.886102.05
3393253-393253100.923101.09
4383198-38319898.34298.51
5386389-38638999.16199.33
6386457-38645799.17999.34
15min1385782-38578299.00599.401.3999.3399.731.38
2395718-395718101.555101.89
3391929-391929100.583100.92
4382013-38201398.03898.37
5383342-38334298.37998.71
6385105-38510598.83299.16
20min1384693-38469398.72699.491.4599.2299.981.45
2395371-395371101.466101.97
3391321-391321100.427100.93
4381100-38110097.80498.29
5382870-38287098.25898.75
6390573-390573100.235100.73
30min1383921-38392198.52899.131.3099.1999.791.30
2393959-393959101.104101.78
3390612-390612100.245100.92
4380552-38055297.66398.32
5383863-38386398.51399.17
6384606-38460698.70499.37
45min1382462-38246298.15399.081.3998.9899.911.39
2393808-393808101.065101.91
3391992-391992100.599101.44
4381677-38167797.95298.77
5382906-38290698.26799.09
6383645-38364598.45799.28
60min1382616-38261698.19398.701.5299.1899.701.52
2393651-393651101.025102.04
3389687-389687100.008101.01
4379226-37922697.32398.30
5379532-37953297.40198.39
6382861-38286198.25699.25
极限1380774-38077497.72098.651.2298.8799.811.22
2391788-391788100.547101.73
3388383-38838399.673100.84
4380073-38007397.54098.68
5381874-38187498.00299.15
6383522-38352298.42599.58
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 10.883792343792023791953791513791443791850.01
2 10.823798703795463797080.07
单位质量响应值RSD%判断
34851.5635093.160.49数据可信
中间条件6月-供试品溶液-3176A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%
5min1343745-34374588.10989.517.1788.1189.517.17
2302725-30272577.59477.59
3366145-36614593.85093.85
4372734-37273495.53995.54
5351070-35107089.98689.99
6358818-35881891.97291.97
10min1417226-417226106.94399.134.16107.0999.284.16
2372102-37210295.37795.51
3384681-38468198.60198.76
4389478-38947899.83199.99
5379817-37981797.35597.50
6377251-37725196.69796.85
15min1424765-424765108.876100.444.25109.20100.754.24
2388140-38814099.48899.78
3386778-38677899.13999.46
4388910-38891099.685100.01
5384989-38498998.68098.99
6377517-37751796.76597.08
20min1424640-424640108.844100.124.43109.35100.604.42
2387191-38719199.24599.70
3384742-38474298.61799.10
4389411-38941199.814100.31
5381173-38117397.70298.18
6376436-37643696.48896.96
30min1425248-425248108.999100.124.53109.69100.764.52
2389245-38924599.771100.39
3385299-38529998.76099.41
4387381-38738199.29399.95
5380945-38094597.64498.28
6375436-37543696.23296.87
45min1424958-424958108.925100.294.40109.79101.104.39
2387666-38766699.366100.15
3388589-38858999.603100.42
4388205-38820599.505100.33
5381847-38184797.87598.68
6376236-37623696.43797.23
60min1423960-423960108.669100.034.42109.72101.024.41
2388676-38867699.625100.58
3385097-38509798.70899.69
4387604-38760499.351100.34
5380935-38093597.64198.61
6375308-37530896.19997.16
极限1423772-423772108.62199.764.48109.85100.914.47
2387080-38708099.216100.33
3383715-38371598.35499.50
4385410-38541098.78899.94
5378954-37895497.13398.26
6376270-37627096.44597.56
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