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500
标示量(mg)30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%
115.351698961699271698601698481699111698880.02
215.331695491695141695320.02
单位质量响应值RSD%判断
11067.6211058.840.06数据可信
供试品溶液-3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%
30min125304-2530413.37213.051.4513.3713.051.43
224293-2429312.83812.84
324460-2446012.92612.93
424859-2485913.13713.14
524557-2455712.97712.98
624696-2469613.05113.05
60min147226-4722624.95724.441.5524.9824.461.55
245624-4562424.11024.13
345235-4523523.90523.93
446334-4633424.48524.51
546463-4646324.55424.58
646618-4661824.63524.66
120min177378-7737840.89140.290.9940.9540.360.99
275578-7557839.93940.00
375460-7546039.87739.94
476543-7654340.44940.51
576711-7671140.53840.60
675834-7583440.07540.14
240min1117388-11738862.03461.121.4862.1761.261.48
2115235-11523560.89661.02
3112704-11270459.55959.69
4116856-11685661.75361.88
5116681-11668161.66061.79
6115144-11514460.84860.98
360min1143711-14371175.94574.991.3776.1875.221.37
2141372-14137274.70974.94
3138985-13898573.44773.67
4143229-14322975.69075.92
5143623-14362375.89876.13
6140489-14048974.24274.47
480min1160918-16091885.03883.931.6685.4084.291.66
2158122-15812283.56083.91
3154563-15456381.67982.03
4160837-16083784.99585.35
5161138-16113885.15485.51
6157372-15737283.16483.52
600min1171012-17101290.37289.701.5690.8890.201.56
2167882-16788288.71889.21
3165174-16517487.28787.77
4171489-17148990.62491.12
5171338-17133890.54491.05
6171550-17155090.65691.15
720min1177447-17744793.77292.611.6194.4393.261.61
2174112-17411292.01092.65
3170799-17079990.25990.89
4177772-17777293.94494.60
5177520-17752093.81194.46
6173814-17381491.85392.50
960min1185628-18562898.09696.331.5698.9197.141.56
2181292-18129295.80496.60
3178046-17804694.08994.87
4184491-18449197.49598.30
5183798-18379897.12997.94
6180518-18051895.39596.19
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186534-18653498.57597.611.4299.5598.571.42
2183708-18370897.08198.04
3180693-18069395.48896.43
4187245-18724598.95099.92
5186934-18693498.78699.76
6183129-18312996.77597.73
1440min1188215-18821599.46398.261.65100.6099.381.64
2184613-18461397.55998.68
3181473-18147395.90097.00
4188907-18890799.829100.96
5188521-18852199.625100.76
6183886-18388697.17598.29
极限1188165-18816599.43698.652.43100.7499.942.41
2184613-18461397.55998.84
3181148-18114895.72896.99
4188470-18847099.598100.90
5193979-193979102.509103.81
6183737-18373797.09698.38
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