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%
115.131739651738031731721736111732141735530.21
215.171718881717011717940.08
单位质量响应值RSD%判断
11470.7911324.590.91数据可信
供试品溶液-1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%
30min127078-2707813.89013.995.4613.8913.995.47
227541-2754114.12814.13
325850-2585013.26013.26
428925-2892514.83814.84
525368-2536813.01313.01
628879-2887914.81414.81
60min150288-5028825.79626.659.6325.8226.689.63
259988-5998830.77230.80
347301-4730124.26424.29
452491-5249126.92626.95
546758-4675823.98524.01
654930-5493028.17728.20
120min183743-8374342.95742.582.7143.0242.652.71
283914-8391443.04543.12
379257-7925740.65640.72
485278-8527843.74543.81
581401-8140141.75641.82
684441-8444143.31543.39
240min1125173-12517364.21063.601.5464.3563.741.55
2125255-12525564.25264.40
3121099-12109962.12062.25
4125036-12503664.13964.28
5122024-12202462.59462.73
6125340-12534064.29564.44
360min1149965-14996576.92776.321.6377.1776.561.63
2149612-14961276.74677.00
3145214-14521474.49074.72
4149383-14938376.62976.88
5146630-14663075.21675.45
6151849-15184977.89478.14
480min1170767-17076787.59886.951.5387.9787.321.54
2171309-17130987.87688.26
3165332-16533284.81085.17
4169738-16973887.07087.45
5167602-16760285.97486.34
6172275-17227588.37188.75
600min1180310-18031092.49391.581.2993.0192.101.30
2180866-18086692.77893.31
3174622-17462289.57590.07
4178163-17816391.39291.91
5177501-17750191.05291.56
6179705-17970592.18392.71
720min1187227-18722796.04194.851.2996.7195.511.29
2187047-18704795.94996.63
3180820-18082092.75593.40
4184690-18469094.74095.41
5183927-18392794.34995.00
6185665-18566595.24095.92
960min1193733-19373399.37998.211.24100.2199.041.24
2193525-19352599.272100.11
3187330-18733096.09496.90
4191136-19113698.04798.88
5190714-19071497.83098.64
6192297-19229798.64299.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1196665-196665100.88399.631.25101.88100.621.25
2196113-196113100.600101.61
3190197-19019797.56598.53
4193031-19303199.019100.01
5193802-19380299.414100.39
6195524-195524100.297101.30
1440min1198132-198132101.635100.341.19102.80101.501.19
2197163-197163101.138102.31
3191452-19145298.20999.33
4195269-195269100.167101.33
5195329-195329100.197101.34
6196329-196329100.710101.88
极限1198193-198193101.667100.361.05103.00101.691.06
2197088-197088101.100102.44
3192215-19221598.60099.89
4195163-195163100.112101.44
5195144-195144100.102101.41
6196122-196122100.604101.94
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%
115.131737051736641736701729591734151734830.19
215.171715151720741717940.24
单位质量响应值RSD%判断
11466.1611324.590.88数据可信
供试品溶液-2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%
30min126061-2606113.37113.212.6113.3713.212.62
224680-2468012.66312.66
325146-2514612.90212.90
426309-2630913.49813.50
526182-2618213.43313.43
626141-2614113.41213.41
60min148007-4800724.63124.554.1124.6524.574.10
245675-4567523.43423.46
346745-4674523.98324.00
447136-4713624.18424.21
548093-4809324.67524.70
651415-5141526.37926.40
120min178490-7849040.27140.952.8240.3341.022.82
278803-7880340.43140.49
377998-7799840.01840.08
479901-7990140.99541.06
579562-7956240.82140.88
684182-8418243.19143.26
240min1117934-11793460.50861.922.4060.6462.052.40
2117127-11712760.09460.22
3120692-12069261.92362.05
4122821-12282163.01663.15
5120732-12073261.94462.08
6124810-12481064.03664.17
360min1142935-14293573.33674.872.2573.5775.102.25
2142059-14205972.88673.11
3146217-14621775.02075.25
4147456-14745675.65575.89
5145686-14568674.74774.98
6151143-15114377.54777.79
480min1163450-16345083.86185.392.3084.2185.752.31
2161919-16191983.07683.42
3165764-16576485.04985.40
4168626-16862686.51786.88
5166169-16616985.25685.62
6172630-17263088.57188.95
600min1173622-17362289.08090.652.1689.5791.152.16
2172822-17282288.67089.16
3175802-17580290.19990.70
4177836-17783691.24291.75
5176534-17653490.57491.08
6183459-18345994.12794.65
720min1179120-17912091.90193.792.2992.5494.442.29
2178042-17804291.34891.98
3182904-18290493.84394.49
4184448-18444894.63595.29
5182537-18253793.65494.31
6189767-18976797.36498.04
960min1186172-18617295.51997.132.0996.3197.942.09
2184408-18440894.61495.40
3189319-18931997.13497.94
4191355-19135598.17998.99
5189000-18900096.97097.78
6195622-195622100.368101.21
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1188771-18877196.85398.652.2097.8199.622.20
2187546-18754696.22497.17
3192365-19236598.69799.66
4193114-19311499.081100.06
5192246-19224698.63699.61
6199600-199600102.409103.42
1440min1190360-19036097.66899.492.3398.78100.632.33
2188568-18856896.74997.85
3193687-19368799.375100.51
4195334-195334100.220101.37
5194036-19403699.554100.69
6201532-201532103.400104.58
极限1190351-19035197.66399.402.2498.94100.702.24
2188617-18861796.77498.04
3193206-19320699.128100.43
4195115-195115100.108101.42
5194037-19403799.555100.86
6201043-201043103.149104.50
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