利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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1000
标示量(mg)10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%
110.153242513252723248823242963251323247670.15
210.173245823237753241780.18
单位质量响应值RSD%判断
31996.7531875.910.27数据可信
供试品溶液-JPS7149批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1284584-28458479.87881.242.6279.8881.242.62
2303398-30339885.15985.16
3292794-29279482.18382.18
4286016-28601680.28080.28
5283748-28374879.64479.64
6286019-28601980.28180.28
10min1328069-32806992.08493.782.5792.2293.922.56
2348037-34803797.68997.83
3335343-33534394.12694.26
4338356-33835694.97195.11
5323765-32376590.87691.01
6331101-33110192.93593.07
15min1339585-33958595.31697.372.5595.6097.662.55
2361009-361009101.330101.63
3347273-34727397.47497.77
4352256-35225698.87399.16
5336754-33675494.52294.81
6344493-34449396.69496.98
20min1345082-34508296.85998.752.5797.3099.202.57
2366439-366439102.854103.33
3351966-35196698.79199.25
4356812-356812100.152100.61
5340986-34098695.70996.15
6349574-34957498.12098.57
30min1350945-35094598.50599.982.5499.11100.602.54
2370413-370413103.969104.61
3355855-35585599.883100.50
4361752-361752101.538102.16
5344339-34433996.65197.25
6353875-35387599.32799.94
45min1350683-35068398.431100.302.6499.20101.082.64
2372273-372273104.491105.31
3357462-357462100.334101.12
4362885-362885101.856102.65
5345499-34549996.97697.74
6355208-35520899.701100.48
60min1349936-34993698.222100.032.6499.16100.982.63
2371267-371267104.209105.20
3357262-357262100.278101.23
4361156-361156101.371102.33
5344158-34415896.60097.52
6354522-35452299.509100.45
极限1350310-35031098.327100.052.4999.43101.172.49
2370286-370286103.934105.10
3357982-357982100.480101.60
4361293-361293101.409102.54
5345013-34501396.84097.92
6353870-35387099.326100.44
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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1000
标示量(mg)10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%
110.154801334818044806734794834819604808110.23
210.174826874808984817920.27
单位质量响应值RSD%判断
47370.5447373.840.01数据可信
供试品溶液-JPS7664批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1410560-41056077.68876.823.1977.6976.823.19
2393641-39364174.48774.49
3410553-41055377.68777.69
4425260-42526080.47080.47
5389519-38951973.70773.71
6406139-40613976.85276.85
10min1469888-46988888.91589.092.6489.0489.222.64
2457059-45705986.48786.61
3481510-48151091.11491.24
4483948-48394891.57591.71
5455068-45506886.11086.23
6477379-47737990.33290.46
15min1490702-49070292.85393.172.6893.1393.452.69
2477325-47732590.32290.59
3503618-50361895.29795.58
4506127-50612795.77296.06
5476226-47622690.11490.38
6500410-50041094.69094.97
20min1502820-50282095.14695.152.6395.5895.592.63
2488789-48878992.49192.91
3514483-51448397.35397.79
4517343-51734397.89498.34
5485594-48559491.88692.30
6508175-50817596.15996.60
30min1510033-51003396.51196.992.8697.1097.582.86
2497032-49703294.05194.62
3526209-52620999.572100.17
4528454-52845499.997100.61
5494199-49419993.51594.08
6519445-51944598.29298.89
45min1514265-51426597.31297.912.9898.0698.662.97
2501511-50151194.89895.63
3531456-531456100.565101.33
4533255-533255100.905101.68
5497698-49769894.17794.90
6526442-52644299.616100.38
60min1513452-51345297.15898.592.6298.0799.512.62
2502906-50290695.16296.05
3535282-535282101.289102.22
4535129-535129101.260102.20
5511486-51148696.78697.67
6528019-52801999.914100.84
极限1514592-51459297.37498.752.9998.4599.832.99
2514944-51494497.44098.49
3539519-539519102.090103.20
4537414-537414101.692102.81
5498613-49861394.35095.39
6526032-52603299.538100.63
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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1000
标示量(mg)10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%
110.154820914804074818974806384814744813010.16
210.174811074818964815020.12
单位质量响应值RSD%判断
47418.8247345.330.11数据可信
供试品溶液-JPS7157批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1410464-41046477.65478.233.6377.6578.243.63
2401499-40149975.95875.96
3403131-40313176.26776.27
4419637-41963779.38979.39
5405417-40541776.69976.70
6441037-44103783.43883.44
10min1479249-47924990.66791.463.4790.8091.583.47
2471939-47193989.28489.41
3470312-47031288.97689.10
4490058-49005892.71292.84
5474596-47459689.78789.91
6514347-51434797.30797.45
15min1501488-50148894.87495.743.5195.1596.023.51
2493023-49302393.27393.55
3493758-49375893.41293.69
4512537-51253796.96597.25
5496353-49635393.90394.18
6539129-539129101.995102.30
20min1513167-51316797.08497.653.4097.5298.093.40
2503741-50374195.30195.73
3501840-50184094.94195.37
4523535-52353599.04599.49
5506514-50651495.82596.26
6548025-548025103.678104.15
30min1515844-51584497.59099.113.6498.1999.723.64
2510438-51043896.56897.16
3511634-51163496.79497.38
4530917-530917100.442101.06
5514790-51479097.39197.98
6559671-559671105.882106.53
45min1522100-52210098.77499.673.5999.54100.443.58
2513457-51345797.13997.89
3512492-51249296.95697.71
4533284-533284100.890101.67
5517496-51749697.90398.66
6562095-562095106.340107.16
60min1521832-52183298.72399.783.6399.65100.723.63
2513883-51388397.21998.13
3513480-51348097.14398.06
4534903-534903101.196102.15
5517367-51736797.87898.80
6562942-562942106.501107.50
极限1523696-52369699.07699.773.63100.17100.873.63
2514808-51480897.39498.47
3511864-51186496.83797.91
4534370-534370101.095102.21
5516644-51664497.74298.82
6562813-562813106.476107.65
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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1000
标示量(mg)10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%
110.154803174824514822364820794812224816610.19
210.174829464822154825800.11
单位质量响应值RSD%判断
47454.2947451.330.01数据可信
供试品溶液-2024112221批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1413589-41358978.12875.874.5078.1375.884.50
2413550-41355078.12178.12
3383062-38306272.36272.36
4415193-41519378.43178.43
5410139-41013977.47777.48
6374405-37440570.72670.73
10min1499488-49948894.35594.230.9994.4994.360.99
2494768-49476893.46393.59
3493467-49346793.21893.34
4507398-50739895.84995.98
5498088-49808894.09194.22
6499661-49966194.38894.51
15min1513366-51336696.97797.191.1797.2697.471.17
2506233-50623395.62995.92
3513493-51349397.00197.28
4524970-52497099.16999.46
5514269-51426997.14797.43
6514489-51448997.18997.46
20min1516360-51636097.54298.071.2797.9998.511.26
2511584-51158496.64097.09
3518504-51850497.94798.38
4531101-531101100.327100.78
5516961-51696197.65698.10
6520302-52030298.28798.72
30min1520281-52028198.28398.831.3698.8999.441.36
2515701-51570197.41898.02
3522130-52213098.63299.23
4536706-536706101.386102.01
5521439-52143998.50299.11
6522935-52293598.78499.39
45min1542240-542240102.431100.211.87103.21100.991.87
2521336-52133698.48299.25
3523843-52384398.95699.72
4543947-543947102.753103.55
5526415-52641599.442100.22
6525188-52518899.21099.98
60min1523572-52357298.90599.681.3599.85100.621.34
2522797-52279798.75899.69
3524653-52465399.109100.04
4541764-541764102.341103.30
5526499-52649999.457100.40
6526640-52664099.484100.42
极限1536082-536082101.268101.091.04102.38102.191.04
2526780-52678099.511100.61
3531782-531782100.455101.55
4543223-543223102.617103.75
5535228-535228101.106102.21
6537667-537667101.567102.66
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