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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.231714201718791716611716081715441716220.10
215.151708071711271709670.14
单位质量响应值RSD%判断
11268.6811284.950.11数据可信
供试品溶液-1231323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%
30min126848-2684814.27113.495.7514.2713.495.76
223176-2317612.31912.32
324967-2496713.27113.27
424397-2439712.96812.97
526800-2680014.24514.25
626069-2606913.85713.86
60min146434-4643424.68123.255.5524.7123.275.56
240393-4039321.47021.49
343008-4300822.86022.88
441679-4167922.15422.18
545841-4584124.36624.39
645083-4508323.96323.99
120min175335-7533540.04337.754.9140.1137.814.92
266229-6622935.20335.26
370148-7014837.28637.35
468016-6801636.15336.21
573159-7315938.88638.95
673219-7321938.91838.98
240min1114533-11453360.87858.173.6761.0158.303.67
2103572-10357255.05255.17
3108140-10814057.48057.60
4106883-10688356.81256.93
5111109-11110959.05859.19
6112442-11244259.76759.89
360min1142229-14222975.59972.522.9875.8372.742.98
2130628-13062869.43369.64
3134886-13488671.69671.91
4134386-13438671.43171.64
5137270-13727072.96473.19
6139198-13919873.98874.22
480min1163462-16346286.88583.522.5487.2483.862.54
2151548-15154880.55380.88
3155670-15567082.74483.08
4155591-15559182.70283.03
5157550-15755083.74384.09
6159009-15900984.51984.87
600min1174895-17489592.96389.562.2793.4790.042.28
2163483-16348386.89787.35
3166659-16665988.58589.06
4167192-16719288.86889.34
5169055-16905589.85890.35
6169710-16971090.20790.70
720min1181445-18144596.44493.052.1497.1093.682.15
2170068-17006890.39791.00
3173394-17339492.16592.79
4174351-17435192.67393.29
5174980-17498093.00893.65
6176115-17611593.61194.25
960min1188741-188741100.32297.051.99101.1497.842.00
2177595-17759594.39895.15
3180926-18092696.16896.95
4182330-18233096.91497.69
5182913-18291397.22498.02
6182976-18297697.25898.06
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1191375-191375101.72298.841.80102.7199.781.81
2181337-18133796.38797.30
3184142-18414297.87898.81
4185371-18537198.53199.47
5186746-18674699.262100.22
6186689-18668999.231100.19
1440min1192456-192456102.29799.621.61103.45100.741.62
2183270-18327097.41498.48
3185873-18587398.79899.90
4187266-18726699.538100.64
5187780-18778099.811100.93
6187931-18793199.892101.02
极限1191801-191801101.94999.461.61103.28100.741.62
2182602-18260297.05998.29
3185874-18587498.798100.06
4186795-18679599.288100.55
5187591-18759199.711101.00
6188073-18807399.967101.26
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.233471603471863469393470083464183469420.09
215.153459833463663461740.08
单位质量响应值RSD%判断
22780.1722849.770.22数据可信
供试品溶液-1224287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%
30min153118-5311813.95513.373.2813.9613.373.29
250379-5037913.23613.24
350175-5017513.18213.18
449741-4974113.06813.07
549108-4910812.90212.90
652792-5279213.87013.87
60min190427-9042723.75723.172.4623.7823.192.46
287648-8764823.02723.05
387984-8798423.11523.14
486409-8640922.70222.72
585617-8561722.49422.52
691062-9106223.92423.95
120min1146050-14605038.37137.641.9438.4337.701.94
2142518-14251837.44337.50
3143395-14339537.67337.73
4139442-13944236.63536.69
5141414-14141437.15337.21
6146714-14671438.54538.61
240min1221121-22112158.09457.451.6758.2257.581.67
2217749-21774957.20857.33
3218003-21800357.27457.40
4212492-21249255.82755.95
5219682-21968257.71557.84
6223088-22308858.61058.74
360min1272972-27297271.71671.031.3871.9471.251.38
2270359-27035971.02971.25
3268953-26895370.66070.88
4263713-26371369.28369.50
5272198-27219871.51371.73
6273933-27393371.96872.19
480min1311449-31144981.82581.081.4282.1781.421.42
2307169-30716980.70081.04
3306784-30678480.59980.94
4301387-30138779.18179.51
5312290-31229082.04682.38
6312691-31269182.15182.50
600min1330751-33075186.89685.941.3387.3886.421.33
2325355-32535585.47885.95
3324928-32492885.36685.84
4320392-32039284.17484.64
5331895-33189587.19687.67
6329396-32939686.54087.02
720min1342412-34241289.95988.991.3590.5889.601.35
2336704-33670488.46089.07
3336173-33617388.32088.93
4331843-33184387.18387.78
5343739-34373990.30890.93
6341444-34144489.70590.33
960min1355304-35530493.34692.291.3394.1293.051.33
2348068-34806891.44592.21
3349000-34900091.69092.45
4344745-34474590.57291.32
5356508-35650893.66394.43
6353972-35397292.99793.77
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1363149-36314995.40894.361.2796.3495.281.27
2355808-35580893.47994.39
3356753-35675393.72794.64
4353203-35320392.79493.69
5364505-36450595.76496.69
6361561-36156194.99095.92
1440min1368122-36812296.71495.631.4597.8096.711.45
2359960-35996094.57095.64
3360759-36075994.78095.85
4357601-35760193.95095.00
5370677-37067797.38598.47
6366943-36694396.40497.49
极限1367467-36746796.54295.571.4897.7996.801.47
2360456-36045694.70095.93
3359956-35995694.56995.80
4356910-35691093.76894.98
5370526-37052697.34698.59
6367199-36719996.47297.72
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