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%
114.721718491720041717321718721721491719210.10
214.771717691719011718350.06
单位质量响应值RSD%判断
11679.4211634.060.28数据可信
供试品溶液-2025032321-js1M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%
30min138016-3801619.46618.9323.2119.4718.9323.20
253344-5334427.31527.31
333236-3323617.01817.02
432597-3259716.69116.69
528991-2899114.84514.84
635602-3560218.23018.23
60min160767-6076731.11630.9419.2831.1530.9719.28
283206-8320642.60642.65
354443-5444327.87727.91
453009-5300927.14327.17
552343-5234326.80226.83
658718-5871830.06730.10
120min194292-9429248.28248.8916.7548.3748.9816.76
2127017-12701765.03965.16
387839-8783944.97845.05
483923-8392342.97343.05
586146-8614644.11144.18
693663-9366347.96048.04
240min1141612-14161272.51274.678.8972.6874.838.91
2171560-17156087.84788.07
3137352-13735270.33170.48
4138358-13835870.84670.99
5140156-14015671.76771.91
6145879-14587974.69774.86
360min1165314-16531484.64986.905.5984.9387.195.61
2188268-18826896.40296.77
3161913-16191382.90783.17
4164934-16493484.45484.72
5169067-16906786.57186.83
6168782-16878286.42586.71
480min1177652-17765290.96793.013.6491.3993.443.67
2193865-19386599.26899.80
3174813-17481389.51389.92
4179422-17942291.87392.28
5182667-18266793.53493.94
6181427-18142792.90093.33
600min1183479-18347993.95096.092.6994.5396.682.72
2196259-196259100.494101.19
3182137-18213793.26393.82
4186763-18676395.63296.19
5189687-18968797.12997.69
6187657-18765796.09096.67
720min1186883-18688395.69397.512.0896.4398.262.11
2196650-196650100.694101.56
3185625-18562595.04995.76
4190052-19005297.31698.03
5192131-19213198.38199.11
6191217-19121797.91398.66
960min1189983-18998397.28198.451.0398.1899.361.07
2194922-19492299.810100.84
3189974-18997497.27698.14
4192470-19247098.55499.43
5193625-19362599.146100.03
6192577-19257798.60999.52
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1188718-18871896.63398.361.0397.6999.441.05
2193755-19375599.212100.41
3190753-19075397.67598.71
4192826-19282698.73699.78
5193518-19351899.091100.14
6193033-19303398.84299.91
1440min1187974-18797496.25298.251.0897.4799.491.08
2193077-19307798.865100.23
3192663-19266398.65399.85
4191217-19121797.91399.12
5192868-19286898.75899.98
6193427-19342799.044100.28
极限1187850-18785096.18897.771.0197.5799.181.02
2192361-19236198.498100.03
3191317-19131797.96499.32
4189389-18938996.97698.35
5192317-19231798.47699.86
6192452-19245298.54599.95
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