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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.221724211723711723321721121718601722190.14
215.231719221720211719720.05
单位质量响应值RSD%判断
11315.3111291.660.15数据可信
供试品溶液-24082201-1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%
30min126235-2623513.91213.845.8113.9113.845.80
225390-2539013.46413.46
326897-2689714.26314.26
428458-2845815.09115.09
523961-2396112.70612.71
625663-2566313.60913.61
60min146907-4690724.87424.794.7724.9024.814.76
245294-4529424.01824.04
347992-4799225.44925.47
450348-5034826.69926.72
544028-4402823.34723.37
645878-4587824.32824.35
120min175075-7507539.81140.493.8239.8840.553.82
275244-7524439.90039.96
378821-7882141.79741.86
480974-8097442.93943.01
573290-7329038.86438.92
674703-7470339.61339.68
240min1117522-11752262.32063.002.4362.4563.132.44
2119752-11975263.50263.63
3120966-12096664.14664.28
4122834-12283465.13665.28
5115232-11523261.10561.23
6116488-11648861.77161.90
360min1142931-14293175.79376.662.2776.0376.902.27
2146186-14618677.51977.75
3147335-14733578.12978.37
4148679-14867978.84179.09
5140848-14084874.68974.92
6141417-14141774.99175.22
480min1159055-15905584.34485.261.8884.7085.631.89
2162506-16250686.17486.54
3163382-16338286.63887.01
4164446-16444687.20287.58
5157404-15740483.46883.82
6157945-15794583.75584.11
600min1167608-16760888.87990.081.8789.3890.591.87
2171904-17190491.15791.66
3172883-17288391.67692.19
4173362-17336291.93092.46
5166565-16656588.32688.82
6166931-16693188.52089.02
720min1172726-17272691.59392.961.7892.2493.621.79
2176887-17688793.80094.46
3178637-17863794.72895.40
4178715-17871594.76995.45
5172186-17218691.30791.94
6172674-17267491.56592.21
960min1178706-17870694.76496.351.7195.5797.171.72
2182944-18294497.01197.83
3185242-18524298.23099.06
4185105-18510598.15799.00
5179014-17901494.92795.72
6179191-17919195.02195.82
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1180821-18082195.88697.731.8696.8598.701.86
2185680-18568098.46299.44
3187936-18793699.659100.65
4188264-18826499.833100.83
5181527-18152796.26097.21
6181555-18155596.27597.23
1440min1181179-18117996.07698.241.8997.2099.371.89
2186286-18628698.78499.93
3188848-188848100.142101.30
4189571-189571100.526101.69
5182627-18262796.84397.95
6183022-18302297.05398.17
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.221721711725631725971725001725711724800.11
215.231720201724231722220.17
单位质量响应值RSD%判断
11332.4611308.080.16数据可信
供试品溶液-24082201-2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%
30min124904-2490413.18712.893.3113.1912.893.30
225557-2555713.53213.53
324467-2446712.95512.96
423816-2381612.61012.61
523334-2333412.35512.36
623980-2398012.69712.70
60min145793-4579324.24723.532.5424.2723.552.54
245498-4549824.09124.11
344975-4497523.81423.84
443731-4373123.15523.18
543257-4325722.90422.92
643335-4333522.94622.97
120min173827-7382739.09138.501.5039.1538.561.50
274287-7428739.33439.40
371743-7174337.98738.05
471937-7193738.09038.15
572522-7252238.40038.46
671941-7194138.09238.15
240min1114368-11436860.55760.321.4360.6860.441.43
2116631-11663161.75561.88
3111961-11196159.28359.41
4113550-11355060.12460.25
5114327-11432760.53560.66
6112665-11266559.65559.78
360min1139005-13900573.60274.191.0973.8374.411.09
2142290-14229075.34275.57
3137988-13798873.06473.29
4139945-13994574.10074.32
5141125-14112574.72574.95
6140305-14030574.29174.51
480min1154417-15441781.76382.991.2082.1183.341.20
2158877-15887784.12484.48
3154694-15469481.90982.25
4156879-15687983.06683.41
5158528-15852883.94084.29
6157039-15703983.15183.50
600min1164621-16462187.16688.241.2487.6588.721.24
2168942-16894289.45489.95
3164094-16409486.88787.37
4166817-16681788.32988.81
5168942-16894289.45489.94
6166424-16642488.12088.61
720min1169612-16961289.80891.401.1790.4492.041.17
2175094-17509492.71193.36
3171209-17120990.65491.28
4172863-17286391.53092.16
5174386-17438692.33692.97
6172582-17258291.38192.01
960min1176588-17658893.50295.201.2594.2895.981.24
2181864-18186496.29697.10
3177765-17776594.12594.90
4179734-17973495.16895.95
5182112-18211296.42797.22
6180685-18068595.67296.46
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1180303-18030395.46996.891.1896.4197.841.18
2185342-18534298.13799.10
3180490-18049095.56896.50
4183441-18344197.13198.07
5184980-18498097.94698.90
6183351-18335197.08398.03
1440min1181967-18196796.35097.761.2997.4598.861.29
2187742-18774299.408100.53
3181729-18172996.22497.32
4185306-18530698.11899.22
5186247-18624798.61799.73
6184759-18475997.82998.93
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240501对照品来源自制对照品使用方法直接使用
对照品含量(%)99.9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%
115.221722901722451721831725121722511722960.08
215.231721621723721722670.09
单位质量响应值RSD%判断
11320.3711311.030.06数据可信
供试品溶液-24082301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%
30min122986-2298612.17612.703.7412.1812.703.71
224852-2485213.16413.16
324701-2470113.08413.08
424370-2437012.90912.91
522741-2274112.04612.05
624204-2420412.82112.82
60min140793-4079321.60822.583.5521.6322.603.55
243711-4371123.15423.18
343507-4350723.04623.07
444077-4407723.34823.37
540659-4065921.53721.56
643002-4300222.77822.80
120min167561-6756135.78836.922.7335.8436.982.73
271591-7159137.92237.98
371448-7144837.84637.91
469897-6989737.02537.09
567217-6721735.60535.66
670500-7050037.34437.40
240min1106651-10665156.49457.831.8956.6157.951.90
2111536-11153659.08159.21
3110886-11088658.73758.86
4108662-10866257.55957.68
5106974-10697456.66556.78
6110305-11030558.42958.55
360min1132257-13225770.05771.781.8470.2772.001.84
2138677-13867773.45873.68
3138047-13804773.12473.35
4133769-13376970.85871.08
5134558-13455871.27671.49
6135704-13570471.88372.10
480min1148737-14873778.78780.741.7279.1181.081.72
2155018-15501882.11482.46
3155541-15554182.39182.73
4150482-15048279.71180.05
5152741-15274180.90881.24
6152060-15206080.54780.89
600min1158404-15840483.90886.261.7784.3786.731.77
2165172-16517287.49387.97
3166288-16628888.08488.56
4161172-16117285.37485.84
5163914-16391486.82687.29
6162141-16214185.88786.36
720min1164785-16478587.28889.471.7987.8990.081.79
2171656-17165690.92791.55
3172378-17237891.31091.94
4166462-16646288.17688.79
5170245-17024590.18090.79
6167880-16788088.92789.54
960min1171361-17136190.77193.331.7991.5194.101.79
2178405-17840594.50295.28
3179817-17981795.25096.03
4174369-17436992.36493.12
5178079-17807994.33095.09
6175170-17517092.78993.55
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1174788-17478892.58695.021.7693.4895.941.76
2181270-18127096.02096.96
3183423-18342397.16098.10
4177106-17710693.81494.73
5181085-18108595.92296.84
6178643-17864394.62895.55
1440min1176089-17608993.27695.731.7794.3296.811.77
2182451-18245196.64697.74
3184677-18467797.82598.92
4178409-17840994.50495.57
5182898-18289896.88297.96
6179821-17982195.25296.33
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