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%
115.101698051699111699491703521703481700730.16
215.111692551691561692060.05
单位质量响应值RSD%判断
11263.1111198.280.41数据可信
供试品溶液-24082301-js2M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%
30min122304-2230411.61111.545.2811.6111.545.30
221224-2122411.04911.05
323237-2323712.09712.10
423852-2385212.41712.42
521348-2134811.11311.11
621034-2103410.95010.95
60min140260-4026020.95821.105.5820.9821.125.58
238469-3846920.02620.04
343796-4379622.79922.82
442843-4284322.30322.32
538801-3880120.19920.22
639038-3903820.32220.34
120min167171-6717134.96835.113.1235.0235.173.13
266144-6614434.43334.48
369985-6998536.43336.49
469710-6971036.28936.35
564502-6450233.57833.63
667204-6720434.98535.04
240min1111038-11103857.80457.812.5757.9257.922.57
2108647-10864756.55956.67
3113073-11307358.86358.98
4114512-11451259.61259.73
5106868-10686855.63355.74
6112148-11214858.38258.49
360min1137237-13723771.44371.321.9271.6571.531.93
2135247-13524770.40770.61
3137671-13767171.66871.89
4141217-14121773.51473.73
5133378-13337869.43469.63
6137232-13723271.44071.65
480min1153335-15333579.82380.071.8680.1580.401.87
2151788-15178879.01779.34
3153817-15381780.07480.41
4159240-15924082.89783.24
5151193-15119378.70879.02
6153495-15349579.90680.23
600min1164488-16448885.62985.671.7286.0986.131.72
2162462-16246284.57485.03
3164514-16451485.64286.11
4169884-16988488.43888.92
5161946-16194684.30584.75
6164109-16410985.43185.89
720min1170459-17045988.73788.801.5889.3489.411.58
2168475-16847587.70488.30
3170317-17031788.66389.28
4175706-17570691.46992.09
5168339-16833987.63488.22
6170227-17022788.61689.22
960min1177717-17771792.51592.351.6193.2793.101.61
2175124-17512491.16691.91
3176802-17680292.03992.80
4182797-18279795.16095.94
5175092-17509291.14991.88
6176876-17687692.07892.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1180570-18057094.00193.811.6294.9194.711.62
2178329-17832992.83493.73
3179800-17980093.60094.51
4185786-18578696.71697.65
5177990-17799092.65893.54
6178703-17870393.02993.93
1440min1181460-18146094.46494.191.6095.5395.251.60
2178925-17892593.14494.19
3180874-18087494.15995.23
4186368-18636897.01998.12
5179193-17919393.28494.32
6178744-17874493.05094.11
极限1181354-18135494.40994.101.6595.6395.321.65
2178221-17822192.77893.98
3180882-18088294.16395.39
4186281-18628196.97498.23
5178695-17869593.02594.22
6179114-17911493.24394.46
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%
115.101691231688891698591695631690831693030.24
215.111695231693191694210.09
单位质量响应值RSD%判断
11212.1211212.510.01数据可信
供试品溶液-24082301-js2M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%
30min122954-2295411.96911.903.3711.9711.903.39
221911-2191111.42511.42
323143-2314312.06712.07
422047-2204711.49611.50
524005-2400512.51712.52
622908-2290811.94511.94
60min141278-4127821.52321.273.4021.5421.293.40
239008-3900820.34020.36
341474-4147421.62621.65
439392-3939220.54020.56
542720-4272022.27522.30
640833-4083321.29121.31
120min169352-6935236.16235.542.2736.2235.602.27
266029-6602934.42934.48
369038-6903835.99836.05
466710-6671034.78434.84
569904-6990436.45036.51
667975-6797535.44435.50
240min1113215-11321559.03358.102.0559.1558.222.05
2108472-10847256.56056.67
3112512-11251258.66758.78
4108948-10894856.80856.92
5114018-11401859.45259.57
6111423-11142358.09958.21
360min1143653-14365374.90572.022.7575.1272.232.75
2132788-13278869.23969.44
3139039-13903972.49972.71
4135440-13544070.62270.83
5140278-14027873.14573.36
6137515-13751571.70471.92
480min1155429-15542981.04580.282.1781.3880.612.17
2148517-14851777.44177.76
3156022-15602281.35481.69
4151707-15170779.10479.43
5157715-15771582.23782.58
6154331-15433180.47280.80
600min1164186-16418685.61185.682.1886.0986.152.18
2158358-15835882.57283.02
3167147-16714787.15587.63
4162365-16236584.66185.12
5168098-16809887.65188.13
6165798-16579886.45286.92
720min1170831-17083189.07688.802.1189.6989.402.11
2164279-16427985.65986.25
3173016-17301690.21590.83
4168082-16808287.64288.24
5174021-17402190.73991.36
6171532-17153289.44190.05
960min1176740-17674092.15792.162.0692.9292.912.06
2170685-17068589.00089.73
3180529-18052994.13394.90
4174825-17482591.15891.90
5179991-17999193.85294.63
6177679-17767992.64793.40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1179325-17932593.50593.752.1594.4294.662.15
2173575-17357590.50791.38
3184123-18412396.00796.93
4177974-17797492.80093.70
5183422-18342295.64196.57
6180308-18030894.01794.93
1440min1179159-17915993.41893.982.0094.4995.052.00
2174317-17431790.89491.92
3183927-18392795.90496.99
4178918-17891893.29394.34
5183658-18365895.76496.85
6181486-18148694.63295.70
极限1179740-17974093.72194.563.4094.9595.783.38
2173992-17399290.72491.90
3192307-192307100.274101.52
4178242-17824292.94094.14
5183110-18311095.47896.73
6180738-18073894.24295.47
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%
115.101689991693401692981686881687341690120.19
215.111691901693801692850.08
单位质量响应值RSD%判断
11192.8511203.510.07数据可信
供试品溶液-24082301-js2M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%
30min121400-2140011.17313.0011.7811.1713.0011.81
222838-2283811.92311.92
322547-2254711.77111.77
427209-2720914.20514.21
527554-2755414.38614.39
627827-2782714.52814.53
60min138363-3836320.02922.737.6520.0522.757.66
242565-4256522.22322.24
341412-4141221.62121.64
446063-4606324.04924.07
545859-4585923.94223.97
646912-4691224.49224.52
120min164387-6438733.61536.685.4233.6736.745.42
269397-6939736.23136.29
367739-6773935.36635.42
472165-7216537.67637.74
573881-7388138.57238.64
674006-7400638.63738.70
240min1108685-10868556.74359.583.0056.8559.703.01
2114444-11444459.75059.87
3111597-11159758.26358.38
4115602-11560260.35460.48
5116441-11644160.79260.92
6117991-11799161.60161.73
360min1135645-13564570.81873.322.7571.0273.542.76
2138377-13837772.24572.46
3137099-13709971.57771.79
4142908-14290874.61074.84
5144504-14450475.44375.67
6144113-14411375.23975.47
480min1152388-15238879.55982.302.7179.8882.642.71
2154643-15464380.73781.07
3154424-15442480.62280.95
4160995-16099584.05384.40
5161846-16184684.49784.85
6161497-16149784.31584.67
600min1162841-16284185.01787.892.5585.4788.362.56
2164928-16492886.10686.58
3165895-16589586.61187.08
4171238-17123889.40189.89
5172706-17270690.16790.66
6172415-17241590.01590.51
720min1169175-16917588.32490.922.6288.9291.552.63
2170664-17066489.10189.72
3170333-17033388.92889.54
4177227-17722792.52893.17
5179175-17917593.54594.19
6178367-17836793.12393.77
960min1175332-17533291.53894.202.7192.2894.982.72
2175983-17598391.87892.64
3176741-17674192.27493.03
4183936-18393696.03096.83
5185610-18561096.90497.71
6184963-18496396.56697.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1178491-17849193.18795.622.4694.0896.562.46
2178644-17864493.26794.18
3180251-18025194.10695.02
4186185-18618597.20498.16
5187899-18789998.09999.06
6187473-18747397.87798.84
1440min1182390-18239095.22395.363.3596.2796.453.33
2179218-17921893.56794.64
3172284-17228489.94791.02
4186745-18674597.49798.61
5188046-18804698.17699.30
6187226-18722697.74898.88
极限1178719-17871993.30793.965.4894.5295.225.43
2179053-17905393.48194.71
3161547-16154784.34185.56
4186449-18644997.34298.62
5187705-18770597.99899.29
6186392-18639297.31298.60
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