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%
114.701688571692741695901691301697451693190.22
214.781681701682371682040.03
单位质量响应值RSD%判断
11518.3011380.510.86数据可信
供试品溶液-2025081221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%
30min127190-2719014.17514.583.2914.1814.583.28
228667-2866714.94514.95
328333-2833314.77114.77
428967-2896715.10215.10
528100-2810014.65014.65
626562-2656213.84813.85
60min148517-4851725.29425.502.5825.3225.522.57
249256-4925625.67925.70
349395-4939525.75225.78
449487-4948725.79925.82
550197-5019726.17026.19
646582-4658224.28524.31
120min178249-7824940.79440.901.1240.8640.961.13
277947-7794740.63740.70
378576-7857640.96541.03
479447-7944741.41941.49
579330-7933041.35841.43
677120-7712040.20640.27
240min1118415-11841561.73461.941.1561.8762.081.15
2118004-11800461.52061.66
3119337-11933762.21562.35
4121099-12109963.13463.27
5118916-11891661.99562.13
6117096-11709661.04761.18
360min1143765-14376574.95075.070.8975.1975.310.88
2142615-14261574.35174.59
3144827-14482775.50475.74
4146029-14602976.13176.37
5142883-14288374.49074.73
6143871-14387175.00575.24
480min1159542-15954283.17583.440.8883.5483.800.87
2158025-15802582.38582.75
3160921-16092183.89484.26
4161791-16179184.34884.72
5159105-15910582.94883.31
6160884-16088483.87584.23
600min1169575-16957588.40688.490.8588.9189.000.84
2167660-16766087.40887.91
3171128-17112889.21689.72
4171067-17106789.18489.69
5168489-16848987.84088.34
6170537-17053788.90789.40
720min1174466-17446690.95691.390.9091.6092.040.89
2172865-17286590.12190.77
3176761-17676192.15292.81
4176944-17694492.24892.91
5174800-17480091.13091.78
6175978-17597891.74492.39
960min1181135-18113594.43394.911.2495.2395.711.23
2179159-17915993.40294.20
3185515-18551596.71697.52
4183389-18338995.60896.42
5180616-18061694.16294.96
6182470-18247095.12995.93
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184562-18456296.21996.610.8897.1897.570.88
2183108-18310895.46196.41
3187394-18739497.69698.66
4186612-18661297.28898.26
5184162-18416296.01196.97
6186011-18601196.97597.93
1440min1187179-18717997.58497.650.6798.7098.770.67
2185830-18583096.88097.99
3189090-18909098.58099.71
4188350-18835098.19499.33
5186167-18616797.05698.17
6187258-18725897.62598.74
极限1186356-18635697.15597.410.7698.4398.690.76
2184559-18455996.21897.49
3188488-18848898.26699.56
4187851-18785197.93499.23
5186289-18628997.12098.40
6187512-18751297.75799.04
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%
114.701684751687281683141683061688161685280.14
214.781680061681601680830.07
单位质量响应值RSD%判断
11464.4911372.330.58数据可信
供试品溶液-2025081221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%
30min127053-2705314.14214.234.0614.1414.234.04
228092-2809214.68514.68
325682-2568213.42513.43
426196-2619613.69413.69
527893-2789314.58114.58
628414-2841414.85314.85
60min147761-4776124.96725.072.5124.9925.092.52
249569-4956925.91225.94
346199-4619924.15024.17
447101-4710124.62224.64
548656-4865625.43525.46
648443-4844325.32325.35
120min177972-7797240.75940.662.0440.8240.722.04
280590-8059042.12842.20
375798-7579839.62339.69
477127-7712740.31840.38
577837-7783740.68940.76
677351-7735140.43540.50
240min1118922-11892262.16662.071.4562.3062.211.45
2121740-12174063.63963.78
3117077-11707761.20161.33
4117782-11778261.57061.70
5119438-11943862.43562.57
6117519-11751961.43261.57
360min1143892-14389275.21975.041.0075.4675.281.01
2145734-14573476.18176.43
3141930-14193074.19374.42
4142643-14264374.56674.80
5144522-14452275.54875.79
6142560-14256074.52274.76
480min1160149-16014983.71783.260.9284.0883.620.92
2161268-16126884.30284.67
3158341-15834182.77283.13
4157622-15762282.39682.75
5160201-16020183.74484.11
6158072-15807282.63182.99
600min1169256-16925688.47788.100.7988.9888.600.80
2170615-17061589.18889.70
3168006-16800687.82488.32
4166713-16671387.14887.64
5168719-16871988.19788.70
6167949-16794987.79488.29
720min1175729-17572991.86191.450.8592.5192.090.84
2175646-17564691.81892.48
3173319-17331990.60191.24
4176940-17694092.49493.13
5174764-17476491.35792.01
6173202-17320290.54091.19
960min1182007-18200795.14394.550.6095.9595.350.60
2181703-18170394.98495.80
3180649-18064994.43395.22
4179257-17925793.70594.50
5181534-18153494.89695.70
6180058-18005894.12494.92
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1185867-18586797.16196.310.7898.1297.270.78
2185576-18557697.00997.98
3183983-18398396.17697.12
4181894-18189495.08496.03
5184290-18429096.33697.30
6183848-18384896.10597.06
1440min1187454-18745497.99097.120.8099.1198.240.79
2187500-18750098.01499.15
3185310-18531096.87097.98
4183696-18369696.02697.14
5185677-18567797.06198.18
6185067-18506796.74397.86
极限1187338-18733897.93096.970.7299.2298.250.72
2186633-18663397.56198.86
3184984-18498496.69997.97
4183725-18372596.04197.31
5185655-18565597.05098.33
6184686-18468696.54397.82
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