乌帕替尼缓释片项目信息
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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44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%
1 15.001709971707871713431710261709421710190.12
2 15.031711401713041712220.07
单位质量响应值RSD%判断
11401.2711392.020.06数据可信
供试品溶液-25021202批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min129040-2904014.89715.075.5614.9015.075.54
228476-2847614.60814.61
332661-3266116.75516.75
428904-2890414.82814.83
528364-2836414.55114.55
628795-2879514.77214.77
60min151588-5158826.46426.581.2326.4926.601.23
251669-5166926.50626.53
351480-5148026.40926.44
451266-5126626.29926.32
553051-5305127.21527.24
651786-5178626.56626.59
120min184323-8432343.25743.131.3143.3343.201.32
281998-8199842.06442.13
383930-8393043.05643.13
484752-8475243.47743.55
584372-8437243.28243.35
685125-8512543.66943.74
240min1128944-12894466.14766.030.9266.2966.170.92
2126786-12678665.04065.18
3128183-12818365.75765.90
4129711-12971166.54166.68
5128560-12856065.95066.09
6130100-13010066.74066.88
360min1154661-15466179.34078.810.9879.5979.060.98
2151455-15145577.69577.94
3153327-15332778.65678.91
4155628-15562879.83680.09
5152609-15260978.28778.54
6154072-15407279.03879.29
480min1169932-16993287.17486.840.9987.5687.220.98
2166698-16669885.51585.89
3170692-17069287.56487.95
4171109-17110987.77888.16
5168131-16813186.25086.63
6169149-16914986.77287.16
600min1179831-17983192.25291.201.1792.7891.731.17
2174840-17484089.69290.21
3177982-17798291.30491.83
4180188-18018892.43592.97
5176149-17614990.36390.89
6177712-17771291.16591.69
720min1184995-18499594.90194.511.1395.5895.191.12
2181553-18155393.13593.80
3185408-18540895.11395.80
4187094-18709495.97896.66
5182236-18223693.48694.16
6184109-18410994.44795.13
960min1191320-19132098.14697.281.0698.9998.111.06
2187094-18709495.97896.80
3189183-18918397.05097.89
4192315-19231598.65699.50
5187880-18788096.38197.21
6189957-18995797.44798.29
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193121-19312199.07098.980.95100.0799.970.95
2190620-19062097.78798.77
3192828-19282898.91999.92
4195869-195869100.479101.49
5191533-19153398.25599.25
6193655-19365599.344100.34
1440min1194857-19485799.96099.720.82101.13100.880.82
2192363-19236398.68199.83
3193830-19383099.433100.60
4197009-197009101.064102.24
5193453-19345399.240100.40
6194808-19480899.935101.10
极限1196284-196284100.69299.861.00102.03101.191.00
2192304-19230498.65199.96
3194201-19420199.624100.96
4197362-197362101.245102.59
5192907-19290798.960100.28
6194886-19488699.975101.31
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