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500
标示量(mg)30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%
114.951692701694461693241691891692951693050.06
215.071691121696841693980.24
单位质量响应值RSD%判断
11324.7511240.740.53数据可信
供试品溶液-0.05mol/L磷酸二氢钠溶液（pH6.8）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%
30min122881-2288111.85612.766.1311.8612.766.12
225458-2545813.19213.19
325526-2552613.22713.23
60min123540-2354012.19812.562.7612.2212.592.76
224870-2487012.88712.91
324323-2432312.60412.63
120min140741-4074121.11122.154.1321.1522.194.13
243404-4340422.49122.53
344067-4406722.83522.88
240min141780-4178021.65021.982.0221.7222.052.03
243385-4338522.48122.56
342071-4207121.80021.88
360min168325-6832535.40536.242.5235.5236.362.52
269663-6966336.09836.22
371810-7181037.21037.33
480min168619-6861935.55735.881.9235.7336.061.92
270766-7076636.66936.85
368340-6834035.41235.59
600min1108729-10872956.34157.411.7356.5757.651.74
2111143-11114357.59257.83
3112511-11251158.30158.54
720min1110781-11078157.40458.072.0957.7358.402.08
2114759-11475959.46659.80
3110663-11066357.34357.68
960min1135459-13545970.19271.271.4670.6171.701.46
2137700-13770071.35371.79
3139453-13945372.26272.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1137197-13719771.09371.881.7871.6372.431.77
2141550-14155073.34873.90
3137394-13739471.19571.75
1440min1151020-15102078.25579.661.5678.9180.331.56
2154602-15460280.11180.79
3155554-15555480.60581.28
极限1153956-15395679.77780.501.8880.5681.301.87
2158694-15869482.23283.04
3153410-15341079.49480.30
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500
标示量(mg)30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%
114.951694911695891693791695581695381695110.05
215.071691551690881691220.03
单位质量响应值RSD%判断
11338.5311222.430.73数据可信
供试品溶液-0.05mol/L磷酸二氢钠溶液（pH6.8）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%
30min126304-2630413.63314.177.4413.6314.177.41
229682-2968215.38415.38
326038-2603813.49513.50
60min124864-2486412.88712.095.9812.9112.115.96
222933-2293311.88611.91
322158-2215811.48411.51
120min143992-4399222.80122.562.6622.8422.612.64
242215-4221521.88021.93
344388-4438823.00623.05
240min141937-4193721.73620.396.8421.8220.476.83
236567-3656718.95219.03
339525-3952520.48520.57
360min171000-7100036.79936.262.8536.9236.372.85
267664-6766435.07035.18
371212-7121236.90837.02
480min168176-6817635.33534.303.6935.5134.473.68
263459-6345932.89033.06
366893-6689334.67034.85
600min1113247-11324758.69558.062.1058.9358.292.10
2109303-10930356.65156.88
3113491-11349158.82159.05
720min1110144-11014457.08655.612.6057.4255.942.59
2107180-10718055.55055.87
3104576-10457654.20154.53
960min1139920-13992072.51971.721.9572.9572.141.95
2135274-13527470.11170.52
3139945-13994572.53272.95
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1137279-13727971.15070.531.3571.7071.071.34
2137002-13700271.00771.54
3133970-13397069.43569.98
1440min1159984-15998482.91880.702.4483.5981.362.43
2152762-15276279.17579.82
3154397-15439780.02280.68
极限1152919-15291979.25678.591.5480.0779.381.53
2153012-15301279.30580.09
3148944-14894477.19677.99
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500
标示量(mg)30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%
114.951688791691901689711690651693431690900.11
215.071688621692051690340.15
单位质量响应值RSD%判断
11310.3711216.590.59数据可信
供试品溶液-0.05mol/L磷酸二氢钠溶液（pH6.8）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%
30min125087-2508713.02212.654.1913.0212.654.20
224818-2481812.88212.88
323203-2320312.04412.04
60min125631-2563113.30413.453.3413.3313.473.32
226875-2687513.95013.97
325215-2521513.08813.11
120min145067-4506723.39322.894.3223.4422.934.33
245316-4531623.52223.57
341902-4190221.75021.79
240min146027-4602723.89123.543.4523.9723.623.46
246473-4647324.12324.21
343569-4356922.61522.69
360min173805-7380538.31037.842.8938.4337.962.89
274398-7439838.61838.74
370499-7049936.59436.71
480min173133-7313337.96138.534.5838.1538.724.58
278042-7804240.50940.70
371522-7152237.12537.30
600min1116349-11634960.39360.231.6860.6460.481.69
2117813-11781361.15361.41
3113959-11395959.15259.39
720min1118679-11867961.60261.300.4961.9561.650.49
2118077-11807761.29061.65
3117542-11754261.01261.35
960min1143588-14358874.53274.151.0274.9874.601.02
2143800-14380074.64275.10
3141188-14118873.28673.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1146526-14652676.05775.820.2976.6376.400.28
2145700-14570075.62876.21
3146011-14601175.79076.35
1440min1160124-16012483.11582.820.4483.8283.520.46
2159781-15978182.93783.65
3158780-15878082.41783.10
极限1166214-16621486.27685.960.6187.1286.800.59
2164459-16445985.36586.21
3166152-16615286.24487.07
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