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%
115.041678671681231680861677461681001679840.11
215.071684361677841681100.28
单位质量响应值RSD%判断
11169.1511155.280.09数据可信
供试品溶液-25010601-1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%
30min127591-2759114.45113.972.6914.4513.972.68
225680-2568013.45013.45
326973-2697314.12814.13
426668-2666813.96813.97
525995-2599513.61513.62
627100-2710014.19414.19
60min149162-4916225.74925.333.2225.7725.363.22
245897-4589724.03924.06
347410-4741024.83224.86
449939-4993926.15626.18
548064-4806425.17425.20
649752-4975226.05826.08
120min179717-7971741.75341.411.7241.8241.481.72
276552-7655240.09540.16
378575-7857541.15541.22
479539-7953941.66041.73
579676-7967641.73241.80
680331-8033142.07542.14
240min1120166-12016662.93962.811.7563.0862.951.75
2115964-11596460.73860.87
3119843-11984362.77062.90
4122147-12214763.97764.11
5120601-12060163.16763.30
6120847-12084763.29663.43
360min1145924-14592476.43076.411.5676.6776.651.57
2142036-14203674.39474.62
3144654-14465475.76576.00
4148386-14838677.72077.96
5147012-14701277.00077.24
6147299-14729977.15077.39
480min1161401-16140184.53784.851.6884.9185.211.68
2158320-15832082.92383.28
3159873-15987383.73684.10
4164671-16467186.24986.62
5165350-16535086.60586.97
6162325-16232585.02185.39
600min1171248-17124889.69489.861.2990.2090.371.29
2168141-16814188.06788.56
3170221-17022189.15689.66
4174397-17439791.34391.86
5173012-17301290.61891.13
6172367-17236790.28090.79
720min1176762-17676292.58293.011.3493.2493.671.34
2174696-17469691.50092.14
3175233-17523391.78192.43
4180092-18009294.32694.99
5180016-18001694.28794.95
6178711-17871193.60394.27
960min1183579-18357996.15396.201.3496.9797.021.34
2180654-18065494.62195.41
3181522-18152295.07595.88
4184703-18470396.74197.57
5187539-18753998.22799.05
6184063-18406396.40697.23
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1186137-18613797.49297.280.8398.4798.250.84
2183376-18337696.04697.00
3184329-18432996.54697.51
4186372-18637297.61698.60
5187308-18730898.10699.09
6186851-18685197.86698.85
1440min1189422-18942299.21398.750.64100.3599.880.65
2186515-18651597.69098.80
3187601-18760198.25999.38
4189238-18923899.117100.27
5189148-18914899.070100.22
6189295-18929599.147100.29
极限1189473-18947399.24098.730.99100.54100.030.99
2185959-18595997.39998.67
3186286-18628697.57198.86
4189692-18969299.354100.67
5190014-19001499.523100.84
6189536-18953699.273100.58
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%
115.041673591682231674561679141679311677770.22
215.071690751688701689720.09
单位质量响应值RSD%判断
11155.3911212.480.37数据可信
供试品溶液-25010601-2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%
30min126827-2682714.02414.076.6614.0214.076.66
224311-2431112.70912.71
329191-2919115.26015.26
426839-2683914.03014.03
528581-2858114.94114.94
625772-2577213.47213.47
60min150069-5006926.17425.616.0026.2025.636.00
244265-4426523.14023.16
351988-5198827.17727.20
448508-4850825.35825.38
551752-5175227.05427.08
647340-4734024.74724.77
120min179082-7908241.34042.864.2741.4142.934.26
277512-7751240.52040.58
385646-8564644.77244.84
480738-8073842.20642.27
582870-8287043.32143.39
686099-8609945.00945.07
240min1118985-11898562.20063.272.4462.3463.412.44
2116825-11682561.07161.20
3125525-12552565.61965.76
4121370-12137063.44763.58
5121982-12198263.76763.91
6121486-12148663.50763.65
360min1142303-14230374.38975.872.0274.6376.112.03
2141489-14148973.96474.19
3149620-14962078.21478.47
4145542-14554276.08376.32
5145891-14589176.26576.51
6145927-14592776.28476.53
480min1156701-15670181.91683.641.6382.2884.011.64
2157357-15735782.25982.61
3163638-16363885.54285.93
4160288-16028883.79184.16
5161544-16154484.44884.82
6160491-16049183.89784.27
600min1166865-16686587.22988.651.3487.7389.161.35
2167310-16731087.46287.95
3172555-17255590.20490.73
4168861-16886188.27388.78
5171141-17114189.46589.98
6170740-17074089.25589.77
720min1172128-17212889.98191.561.4890.6392.221.48
2172605-17260590.23090.87
3178984-17898493.56594.24
4174763-17476391.35892.01
5176801-17680192.42393.09
6175658-17565891.82692.49
960min1179439-17943993.80294.800.9494.6095.610.95
2179767-17976793.97494.76
3183992-18399296.18297.02
4180886-18088694.55995.37
5182252-18225295.27396.09
6181763-18176395.01795.83
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1182714-18271495.51496.250.9396.4797.220.94
2182347-18234795.32396.26
3187099-18709997.80798.80
4183636-18363695.99696.96
5184396-18439696.39497.37
6184589-18458996.49597.47
1440min1185120-18512096.77297.220.5797.8898.350.58
2185158-18515896.79297.89
3187957-18795798.25599.41
4185590-18559097.01898.14
5185947-18594797.20498.34
6186119-18611997.29498.43
极限1184422-18442296.40796.970.7097.6898.260.71
2184667-18466796.53597.80
3187821-18782198.18499.51
4184527-18452796.46297.75
5185860-18586097.15998.46
6185699-18569997.07598.37
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