非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.291967236196907119769211967433196787319697070.21
210.431953992195616919550800.08
单位质量响应值RSD%判断
191419.53187447.751.49数据可信
供试品溶液-2024092211批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1812272-81227238.59535.5913.8438.6035.5913.83
2646317-64631730.71030.71
3857208-85720840.73040.73
4770309-77030936.60136.60
5811203-81120338.54538.54
6597001-59700128.36728.37
10min11811872-181187286.09274.968.3186.1875.048.32
21545001-154500173.41173.48
31607077-160707776.36176.45
41546550-154655073.48573.57
51542050-154205073.27173.36
61413603-141360367.16867.23
15min12009355-200935595.47591.444.0695.7591.684.06
21952432-195243292.77093.00
31919529-191952991.20791.47
41949278-194927892.62092.87
51937832-193783292.07792.33
61777606-177760684.46384.68
20min12079970-207997098.83096.642.7999.3297.092.80
22052367-205236797.51997.96
32008935-200893595.45595.92
42081719-208171998.91399.36
52048608-204860897.34097.79
61931858-193185891.79392.19
30min12155815-2155815102.43499.342.22103.14100.002.23
22093135-209313599.456100.11
32044604-204460497.15097.82
42121620-2121620100.809101.48
52096533-209653399.617100.29
62032836-203283696.59197.19
45min12119451-2119451100.70699.381.74101.64100.271.75
22100607-210060799.811100.69
32050612-205061297.43598.33
42129208-2129208101.170102.06
52107494-2107494100.138101.03
62042481-204248197.04997.87
60min12117806-2117806100.62899.231.74101.79100.341.75
22096992-209699299.639100.74
32047329-204732997.27998.39
42124265-2124265100.935102.05
52104279-210427999.985101.10
62039639-203963996.91497.95
极限12118030-2118030100.63999.151.67102.02100.471.68
22097080-209708099.643100.96
32045721-204572197.20398.53
42116518-2116518100.567101.91
52102166-210216699.885101.22
62040175-204017596.93998.19
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.291994456199711719953151995544199641219957690.06
210.431989994199064319903180.03
单位质量响应值RSD%判断
193952.28190826.271.15数据可信
供试品溶液-2024092211批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1413508-41350819.34537.4434.1419.3537.4434.14
21064965-106496549.82349.82
3967032-96703245.24145.24
4777479-77747936.37336.37
51039432-103943248.62848.63
6539568-53956825.24325.24
10min11410367-141036765.98276.3911.2166.0276.4711.24
21805549-180554984.46984.58
31784748-178474883.49683.60
41646335-164633577.02177.10
51745598-174559881.66581.77
61404427-140442765.70465.76
15min11827355-182735585.49090.364.8685.6890.614.90
22025408-202540894.75595.05
31998063-199806393.47693.76
41985024-198502492.86693.12
51950373-195037391.24591.53
61802177-180217784.31284.51
20min11968782-196878292.10695.402.9692.4995.852.99
22104889-210488998.47498.98
32061941-206194196.46496.96
42101784-210178498.32898.79
52022799-202279994.63395.13
61974574-197457492.37792.77
30min12047041-204704195.76797.311.5096.3597.981.53
22096900-209690098.10098.83
32089055-208905597.73398.44
42129245-212924599.613100.29
52063797-206379796.55197.25
62054135-205413596.09996.69
45min12062265-206226596.47997.771.3197.2898.651.33
22102858-210285898.37999.32
32096745-209674598.09399.02
42135023-213502399.883100.78
52071417-207141796.90897.82
62071182-207118296.89797.70
60min12060390-206039096.39297.701.2097.4098.801.23
22098577-209857798.17899.34
32094738-209473897.99999.14
42129986-212998699.648100.77
52071984-207198496.93498.07
62074287-207428797.04298.07
极限12060514-206051496.39897.641.1697.6298.961.19
22098536-209853698.17699.56
32094559-209455997.99099.35
42126082-212608299.465100.81
52069896-206989696.83698.18
62073121-207312196.98798.23
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