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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
115.224815244814014815254815304813634814690.02
215.224803024804414803720.03
单位质量响应值RSD%判断
31633.9731561.890.17数据可信
供试品溶液-24080201批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1245754-24575446.29248.894.0846.2948.894.09
2263661-26366149.66549.67
3262658-26265849.47649.48
4274284-27428451.66651.67
5248632-24863246.83446.83
6262170-26217049.38449.38
10min1353101-35310166.51368.983.3066.5969.063.30
2356015-35601567.06167.14
3360341-36034167.87667.96
4380300-38030071.63671.72
5366443-36644369.02669.10
6381029-38102971.77371.86
15min1396877-39687774.75976.982.6074.9577.182.60
2398457-39845775.05675.25
3404032-40403276.10676.30
4418844-41884478.89679.10
5411629-41162977.53777.73
6422256-42225679.53979.74
20min1419099-41909978.94480.892.4779.2681.222.47
2417365-41736578.61878.94
3425923-42592380.23080.55
4440127-44012782.90583.24
5431240-43124081.23181.55
6442849-44284983.41883.75
30min1438265-43826582.55584.582.6183.0085.042.61
2434386-43438681.82482.27
3447140-44714084.22684.68
4462035-46203587.03287.51
5449730-44973084.71485.17
6462467-46246787.11487.59
45min1452162-45216285.17287.232.8385.7587.832.83
2445367-44536783.89284.48
3462888-46288887.19387.79
4477341-47734189.91590.54
5463041-46304187.22287.82
6477824-47782490.00690.62
60min1459191-45919186.49688.752.9987.2289.502.99
2452069-45206985.15585.88
3471748-47174888.86289.60
4486102-48610291.56692.34
5470587-47058788.64389.39
6487190-48719091.77192.54
极限1475358-47535889.54290.452.0790.4191.342.08
2463838-46383887.37288.24
3481846-48184690.76491.65
4489774-48977492.25793.18
5479551-47955190.33291.22
6490594-49059492.41293.33
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数1000
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%
115.224807134806774806864808074804344806630.03
215.224815554814974815260.01
单位质量响应值RSD%判断
31581.0131637.710.13数据可信
供试品溶液-24080202批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1282637-28263753.22050.228.4753.2250.228.48
2276516-27651652.06852.07
3278276-27827652.39952.40
4284154-28415453.50653.51
5227787-22778742.89242.89
6251006-25100647.26447.26
10min1383296-38329672.17470.664.0672.2670.744.07
2396321-39632174.62774.71
3374026-37402670.42970.52
4381113-38111371.76371.85
5353549-35354966.57366.64
6363243-36324368.39868.48
15min1413873-41387377.93277.372.8378.1477.572.83
2429792-42979280.92981.14
3404865-40486576.23676.44
4416684-41668478.46178.67
5399007-39900775.13375.31
6401152-40115275.53675.73
20min1429115-42911580.80280.602.7981.1480.942.80
2447179-44717984.20384.55
3420014-42001479.08879.42
4436483-43648382.18982.53
5417526-41752678.62078.93
6418102-41810278.72879.05
30min1446297-44629784.03783.812.5884.5184.272.58
2464886-46488687.53788.02
3435542-43554282.01282.48
4450466-45046684.82285.30
5437264-43726482.33682.77
6436036-43603682.10582.55
45min1456803-45680386.01586.082.9486.6386.692.94
2480095-48009590.40191.03
3447345-44734584.23584.83
4465004-46500487.56088.18
5447434-44743484.25184.83
6446255-44625584.02984.62
60min1463659-46365987.30687.602.9588.0688.352.95
2489160-48916092.10892.89
3454838-45483885.64586.39
4473003-47300389.06689.83
5455406-45540685.75286.47
6455257-45525785.72486.45
极限1475434-47543489.52489.152.1790.4390.042.18
2491903-49190392.62593.56
3465851-46585187.71988.60
4475221-47522189.48490.40
5468935-46893588.30089.16
6463383-46338387.25488.12
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