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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48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%
114.411660911662301658231662361660171660790.11
214.361646531647431646980.04
单位质量响应值RSD%判断
11525.2611469.220.35数据可信
供试品溶液-2025032321-bc2-js3M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%
30min134519-3451917.92119.255.3717.9219.255.37
236866-3686619.13919.14
335500-3550018.43018.43
438108-3810819.78419.78
537267-3726719.34719.35
640176-4017620.85820.86
60min158999-5899930.63031.613.4730.6631.643.48
261702-6170232.03332.06
358984-5898430.62230.65
460530-6053031.42431.46
560453-6045331.38431.42
664645-6464533.56133.60
120min192669-9266948.10949.253.3948.1949.343.38
296308-9630849.99950.08
394025-9402548.81348.90
491793-9179347.65547.74
593776-9377648.68448.77
6100633-10063352.24452.33
240min1137730-13773071.50374.624.3771.6674.794.37
2145289-14528975.42775.60
3138423-13842371.86372.03
4139085-13908572.20772.37
5149391-14939177.55777.72
6152478-15247879.16079.34
360min1162660-16266084.44687.284.3684.7387.574.36
2167345-16734586.87887.17
3161433-16143383.80984.09
4162898-16289884.56984.85
5176122-17612291.43491.73
6178205-17820592.51692.83
480min1175621-17562191.17493.543.5091.6093.983.50
2178723-17872392.78593.22
3174603-17460390.64691.07
4175887-17588791.31291.74
5188053-18805397.62898.08
6188162-18816297.68598.15
600min1181516-18151694.23596.683.0694.8197.283.06
2185056-18505696.07396.67
3180877-18087793.90394.48
4183303-18330395.16295.74
5193810-193810100.617101.23
6192804-192804100.095100.72
720min1185639-18563996.37598.302.6097.1199.062.61
2188024-18802497.61398.37
3185338-18533896.21996.95
4185907-18590796.51497.25
5195513-195513101.501102.28
6195651-195651101.573102.37
960min1189899-18989998.58799.861.8799.48100.771.88
2190535-19053598.91799.83
3189535-18953598.39899.29
4190226-19022698.75799.65
5196380-196380101.951102.90
6197487-197487102.526103.49
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190577-19057798.939100.331.2699.99101.421.28
2194217-194217100.828101.91
3191101-19110199.211100.27
4191875-19187599.613100.67
5195282-195282101.381102.50
6196526-196526102.027103.16
1440min1190508-19050898.903100.011.09100.12101.261.11
2191885-19188599.618100.87
3191615-19161599.478100.70
4191776-19177699.561100.79
5193744-193744100.583101.87
6196334-196334101.928103.23
极限1190327-19032798.80999.710.86100.19101.120.88
2190759-19075999.033100.45
3191801-19180199.574100.96
4191489-19148999.412100.81
5193268-193268100.336101.79
6194677-194677101.067102.54
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