利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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800
标示量(mg)15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%
112.13 4790744795444805674792064797494796280.13
212.074784984782464783720.04
单位质量响应值RSD%判断
39540.6439633.140.17数据可信
供试品溶液-2024010711批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1380654-38065471.82971.472.6171.8371.472.61
2361208-36120868.16068.16
3388243-38824373.26173.26
4380451-38045171.79171.79
5386913-38691373.01073.01
6375001-37500170.76270.76
10min1448086-44808684.55385.211.8184.7185.361.81
2445055-44505583.98184.13
3466655-46665588.05788.22
4449645-44964584.84885.01
5454411-45441185.74785.91
6445400-44540084.04784.20
15min1486046-48604691.71692.361.3592.0692.711.34
2490821-49082192.61792.96
3500248-50024894.39694.75
4485957-48595791.70092.05
5492243-49224392.88693.24
6481355-48135590.83191.18
20min1493039-49303993.03693.921.2593.5994.471.25
2496434-49643493.67794.22
3509432-50943296.12996.70
4496082-49608293.61094.16
5492571-49257192.94893.51
6498764-49876494.11694.66
30min1498890-49889094.14096.451.8294.9097.211.82
2506157-50615795.51196.26
3520602-52060298.23799.02
4513032-51303296.80997.57
5522642-52264298.62299.39
6505485-50548595.38596.14
45min1505137-50513795.31997.302.3596.2998.282.34
2502492-50249294.82095.78
3529915-52991599.994100.99
4518993-51899397.93498.91
5529015-52901599.825100.81
6508355-50835595.92696.89
60min1509730-50973096.18698.141.9097.3699.331.89
2514339-51433997.05598.23
3530180-530180100.044101.27
4522688-52268898.63199.82
5532486-532486100.480101.69
6511089-51108996.44297.62
极限1517831-51783197.71499.281.4399.11100.691.43
2521669-52166998.43899.83
3533730-533730100.714102.16
4527753-52775399.587101.00
5535761-535761101.098102.53
6519989-51998998.12199.52
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院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800
标示量(mg)15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%
112.13 4818724807204802724797204802684805700.17
212.074735594734174734880.03
单位质量响应值RSD%判断
39618.3039228.500.70数据可信
供试品溶液-2024010711批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1273524-27352451.82961.0611.2051.8361.0611.20
2317948-31794860.24760.25
3382638-38263872.50572.50
4335327-33532763.54063.54
5318891-31889160.42560.43
6305195-30519557.83057.83
10min1351143-35114366.53775.868.4166.6575.998.42
2402809-40280976.32776.46
3448829-44882985.04785.21
4423147-42314780.18080.32
5393443-39344374.55274.69
6382580-38258072.49472.62
15min1393339-39333974.53281.795.8074.8082.105.81
2439724-43972483.32283.63
3465063-46506388.12388.47
4448313-44831384.94985.27
5422815-42281580.11880.42
6420588-42058879.69679.99
20min1420468-42046879.67384.883.9480.1085.363.97
2455706-45570686.35086.84
3471906-47190689.42089.97
4456329-45632986.46886.98
5439046-43904683.19383.67
6444102-44410284.15184.62
30min1438470-43847083.08487.072.8783.6987.752.90
2465732-46573288.25088.93
3478085-47808590.59091.34
4461823-46182387.50988.21
5453496-45349685.93186.59
6459474-45947487.06487.72
45min1445806-44580684.47487.802.5385.2688.672.56
2467149-46714988.51889.39
3481927-48192791.31892.26
4463996-46399687.92188.82
5460256-46025687.21288.07
6461063-46106387.36588.21
60min1445373-44537384.39287.872.6285.3788.932.65
2468047-46804788.68889.76
3482526-48252691.43292.58
4465687-46568788.24189.33
5460354-46035487.23188.28
6460335-46033587.22788.27
极限1490223-49022392.89094.041.2894.0695.301.31
2502486-50248695.21496.48
3503195-50319595.34896.70
4496225-49622594.02895.31
5487633-48763392.40093.64
6498133-49813394.38995.62
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