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%
1 15.191774151758751762251766401763911765090.33
2 15.151772421766901769660.23
单位质量响应值RSD%判断
11620.0811680.920.37数据可信
加速3月-供试品溶液-2025081321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%
30min126308-2630813.47813.413.9013.4813.413.90
226656-2665613.65713.66
324750-2475012.68012.68
425221-2522112.92112.92
526608-2660813.63213.63
627521-2752114.10014.10
60min147262-4726224.21324.272.4124.2424.292.39
247476-4747624.32324.35
346404-4640423.77423.80
446055-4605523.59523.62
547707-4770724.44124.46
649288-4928825.25125.27
120min176750-7675039.32139.581.9239.3839.641.92
278026-7802639.97540.04
375955-7595538.91438.97
475650-7565038.75738.82
577490-7749039.70039.76
679650-7965040.80740.87
240min1116579-11657959.72659.531.1959.8559.661.19
2117866-11786660.38660.52
3114059-11405958.43558.56
4115239-11523959.04059.17
5116281-11628159.57459.70
6117205-11720560.04760.18
360min1142678-14267873.09772.371.4273.3372.601.42
2144082-14408273.81774.05
3138566-13856670.99171.21
4140550-14055072.00772.23
5139891-13989171.67071.90
6141741-14174172.61772.85
480min1167175-16717585.64884.691.2786.0085.031.27
2167517-16751785.82386.18
3162140-16214083.06883.41
4165501-16550184.79085.13
5163577-16357783.80584.15
6165867-16586784.97885.33
600min1176722-17672290.53989.961.0391.0390.451.02
2176524-17652490.43890.93
3172909-17290988.58689.07
4176795-17679590.57691.06
5173686-17368688.98489.47
6176890-17689090.62591.12
720min1183145-18314593.83093.421.0794.4794.061.06
2183112-18311293.81394.46
3179188-17918891.80292.43
4184154-18415494.34794.98
5180813-18081392.63593.27
6183717-18371794.12394.77
960min1191507-19150798.11496.971.1598.9197.761.15
2189704-18970497.19097.99
3185923-18592395.25396.03
4190200-19020097.44498.24
5187419-18741996.01996.81
6190908-19090897.80798.61
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193593-19359399.18298.150.93100.1599.110.93
2190693-19069397.69798.66
3189251-18925196.95897.90
4191773-19177398.25099.21
5190496-19049697.59698.55
6193660-19366099.217100.18
1440min1194067-19406799.42598.381.09100.5599.501.08
2190995-19099597.85198.98
3189304-18930496.98598.09
4193550-19355099.160100.28
5190327-19032797.50998.62
6193948-19394899.364100.50
极限1195239-195239100.02698.991.07101.32100.271.06
2191115-19111597.91399.20
3194225-19422599.506100.77
4194007-19400799.395100.68
5190174-19017497.43198.71
6194526-19452699.660100.96
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%
1 15.191760841764951760171770301767791764810.25
2 15.151769421767641768530.08
单位质量响应值RSD%判断
11618.2411673.470.34数据可信
中间条件3月-供试品溶液-2025081321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%
30min127161-2716113.92113.234.0513.9213.234.05
226887-2688713.78013.78
325270-2527012.95212.95
425252-2525212.94212.94
524449-2444912.53112.53
625895-2589513.27213.27
60min147808-4780824.50323.842.8924.5323.862.88
245883-4588323.51623.54
348062-4806224.63324.65
446277-4627723.71823.74
544401-4440122.75722.78
646642-4664223.90523.93
120min177263-7726339.60038.781.3239.6638.841.31
275223-7522338.55438.62
375468-7546838.68038.74
475922-7592238.91238.97
574236-7423638.04838.11
675841-7584138.87138.93
240min1116289-11628959.60158.471.0959.7358.601.09
2113517-11351758.18158.31
3113784-11378458.31858.44
4114044-11404458.45158.58
5112543-11254357.68257.80
6114302-11430258.58358.71
360min1142673-14267373.12471.880.9273.3572.110.92
2140190-14019071.85172.07
3139058-13905871.27171.50
4140408-14040871.96372.19
5139444-13944471.46971.69
6139733-13973371.61771.84
480min1167534-16753485.86684.091.0886.2284.441.08
2163442-16344283.76984.11
3163300-16330083.69684.04
4164140-16414084.12684.47
5162657-16265783.36683.70
6163379-16337983.73684.08
600min1177607-17760791.02989.400.9291.5289.880.91
2173183-17318388.76189.24
3173793-17379389.07489.56
4173998-17399889.17989.66
5173974-17397489.16789.64
6174047-17404789.20489.69
720min1184299-18429994.45993.110.7395.1093.740.73
2181206-18120692.87393.50
3180715-18071592.62293.25
4181062-18106292.79993.43
5181535-18153593.04293.67
6181152-18115292.84693.48
960min1190402-19040297.58796.400.6798.3997.190.67
2187219-18721995.95596.74
3187175-18717595.93396.72
4187247-18724795.96996.76
5188431-18843196.57697.36
6188052-18805296.38297.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1193158-19315898.99998.000.5799.9798.950.57
2190567-19056797.67198.62
3190898-19089897.84198.79
4190204-19020497.48598.43
5191704-19170498.25499.19
6190700-19070097.73998.69
1440min1192967-19296798.90198.090.57100.0399.200.57
2190606-19060697.69198.80
3191839-19183998.32399.43
4190169-19016997.46798.58
5192088-19208898.45199.56
6190625-19062597.70198.81
极限1193092-19309298.96597.940.72100.2699.210.72
2190743-19074397.76199.03
3189371-18937197.05898.33
4190058-19005897.41098.68
5192193-19219398.50499.77
6191053-19105397.92099.19
点击查看处理图标(人工保存)
　
原始图谱下载图谱(姜进硙 于 2025-12-16 11:36:00 完成)
生成报告数据部分下载报告( 于 2026-01-02 05:11:13 完成)
Current page cost:59 ms