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%
110.993795583803683797003798683794383797860.10
211.073796063800373798220.09
单位质量响应值RSD%判断
34557.4234310.930.51数据可信
供试品溶液-24062601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%
5min1390817-390817101.74099.912.27101.7499.922.27
2381346-38134699.27499.27
3385186-385186100.274100.27
4389388-389388101.368101.37
5388648-388648101.175101.18
6367451-36745195.65795.66
10min1398444-398444103.725101.981.76103.89102.151.76
2388662-388662101.179101.34
3392874-392874102.275102.44
4395936-395936103.072103.24
5395169-395169102.873103.04
6379447-37944798.78098.94
15min1397316-397316103.432101.951.57103.77102.281.58
2388412-388412101.114101.45
3392410-392410102.155102.49
4395290-395290102.904103.25
5395438-395438102.943103.28
6380789-38078999.12999.45
20min1398271-398271103.680101.801.52104.20102.311.52
2387821-387821100.960101.46
3391714-391714101.973102.48
4394998-394998102.828103.34
5392232-392232102.108102.62
6381281-38128199.25799.75
30min1397604-397604103.507101.761.55104.19102.441.55
2387320-387320100.830101.50
3391204-391204101.841102.52
4394675-394675102.744103.43
5393812-393812102.520103.20
6380862-38086299.14899.80
45min1398070-398070103.628101.701.65104.49102.541.65
2386609-386609100.644101.48
3390962-390962101.778102.63
4394752-394752102.764103.62
5393435-393435102.421103.27
6380131-38013198.95899.78
60min1397677-397677103.526101.591.74104.56102.601.74
2386888-386888100.717101.72
3390309-390309101.608102.62
4393947-393947102.555103.58
5393996-393996102.567103.59
6378625-37862598.56699.55
极限1396341-396341103.178101.391.71104.38102.571.71
2385564-385564100.372101.55
3391939-391939102.032103.22
4392855-392855102.270103.47
5392155-392155102.088103.28
6377971-37797198.39699.54
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%
110.993802143798763796863799963799673799480.06
211.073816323821173818740.09
单位质量响应值RSD%判断
34572.1634496.300.16数据可信
供试品溶液-24071001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%
5min1378905-37890598.35297.991.1198.3597.991.11
2372197-37219796.61196.61
3384009-38400999.67799.68
4376477-37647797.72297.72
5374324-37432497.16397.16
6379134-37913498.41198.41
10min1384400-38440099.77899.721.0299.9499.881.02
2378989-37898998.37498.53
3388458-388458100.832101.00
4384543-38454399.81599.98
5380380-38038098.73598.90
6388240-388240100.775100.94
15min1384738-38473899.86699.691.05100.20100.021.05
2378764-37876498.31598.64
3387619-387619100.614100.95
4383980-38398099.669100.00
5380201-38020198.68899.01
6388949-388949100.959101.29
20min1383669-38366999.58999.651.09100.09100.141.09
2378159-37815998.15898.65
3387711-387711100.638101.14
4385221-38522199.991100.49
5379980-37998098.63199.12
6388616-388616100.873101.37
30min1382756-38275699.35299.460.99100.01100.120.99
2378273-37827398.18898.84
3385725-385725100.122100.79
4384762-38476299.872100.53
5379421-37942198.48699.14
6388112-388112100.742101.41
45min1383343-38334399.50499.471.13100.33100.301.13
2377056-37705697.87298.69
3386619-386619100.354101.19
4384272-38427299.745100.57
5379407-37940798.48299.30
6388537-388537100.852101.69
60min1382603-38260399.31299.251.06100.31100.241.06
2376836-37683697.81598.79
3385816-385816100.146101.15
4383195-38319599.466100.46
5378511-37851198.25099.23
6387137-387137100.489101.49
极限1381193-38119398.94699.071.06100.11100.231.07
2376167-37616797.64198.78
3385233-38523399.995101.17
4382923-38292399.395100.56
5377950-37795098.10499.25
6386471-386471100.316101.49
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%
110.993798083798023797853796353795363797130.04
211.073802993804403803700.03
单位质量响应值RSD%判断
34550.7734360.430.40数据可信
供试品溶液-24071002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%
5min1380886-38088699.09298.601.1199.0998.601.11
2373118-37311897.07197.07
3376866-37686698.04798.05
4385432-385432100.275100.28
5380001-38000198.86298.86
6377572-37757298.23098.23
10min1388626-388626101.106100.751.06101.27100.921.06
2381639-38163999.28899.45
3387091-387091100.707100.87
4393599-393599102.400102.57
5388289-388289101.018101.18
6384363-38436399.997100.16
15min1388684-388684101.121100.901.12101.45101.241.12
2381792-38179299.32899.66
3387503-387503100.814101.15
4394630-394630102.668103.01
5389407-389407101.309101.64
6385099-385099100.188100.52
20min1387762-387762100.881100.861.12101.38101.361.12
2381881-38188199.35199.84
3387194-387194100.733101.23
4394736-394736102.696103.20
5389494-389494101.332101.83
6385019-385019100.168100.67
30min1387625-387625100.846100.731.12101.52101.401.12
2381371-38137199.21999.88
3386715-386715100.609101.28
4394345-394345102.594103.27
5388496-388496101.072101.74
6384618-384618100.063100.73
45min1386392-386392100.525100.461.21101.36101.301.21
2380482-38048298.98799.81
3386173-386173100.468101.30
4393687-393687102.423103.27
5388044-388044100.955101.79
6382127-38212799.415100.25
60min1384408-384408100.009100.241.16101.01101.241.16
2379864-37986498.82799.82
3385301-385301100.241101.24
4393119-393119102.275103.30
5386454-386454100.541101.55
6382672-38267299.557100.55
极限1385281-385281100.236100.131.18101.41101.301.18
2378898-37889898.57599.73
3384248-38424899.967101.14
4392423-392423102.094103.29
5386182-386182100.470101.65
6382182-38218299.430100.59
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%
110.993809793810583809093811613808643809940.04
211.073817403818003817700.02
单位质量响应值RSD%判断
34667.3334486.900.37数据可信
供试品溶液-3401B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%
5min1368443-36844395.51894.400.8595.5294.410.85
2364498-36449894.49694.50
3361797-36179793.79593.80
4363943-36394394.35294.35
5359846-35984693.28993.29
6366356-36635694.97794.98
10min1376865-37686597.70297.510.7597.8697.660.75
2376649-37664997.64697.80
3373167-37316796.74396.90
4380337-38033798.60298.76
5372772-37277296.64196.80
6376907-37690797.71397.87
15min1376968-37696897.72897.390.9898.0597.720.98
2377068-37706897.75498.07
3372419-37241996.54996.87
4381127-38112798.80799.13
5370838-37083896.13996.46
6375669-37566997.39297.71
20min1375240-37524097.28097.210.9397.7797.700.93
2376197-37619797.52898.01
3372291-37229196.51696.99
4380407-38040798.62099.11
5370378-37037896.02096.50
6375344-37534497.30797.79
30min1375631-37563197.38297.150.9198.0397.800.91
2375597-37559797.37398.02
3371638-37163896.34796.99
4379841-37984198.47399.12
5370322-37032296.00596.64
6375407-37540797.32497.97
45min1375092-37509297.24296.890.9598.0597.700.95
2374775-37477597.16097.97
3370784-37078496.12596.93
4379137-37913798.29199.11
5369150-36915095.70296.50
6373559-37355996.84597.65
60min1374436-37443697.07296.710.8798.0497.670.87
2374062-37406296.97597.94
3370097-37009795.94796.91
4378002-37800297.99698.97
5369046-36904695.67596.63
6372531-37253196.57897.55
极限1372841-37284196.65896.540.8597.7997.670.85
2373313-37331396.78197.91
3369076-36907695.68296.80
4377306-37730697.81698.96
5368765-36876595.60296.72
6372984-37298496.69597.83
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