非奈利酮片项目信息
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FN-706-231101对照品来源自制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1000
标示量(mg)10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%
111.143853243853373854723853553853703853720.02
211.203850123851553850840.03
单位质量响应值RSD%判断
34593.5434382.500.44数据可信
供试品溶液-BXJUS91批-pH4.5(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1141866-14186637.02237.0710.8337.0237.0710.83
2136557-13655735.63635.64
3155399-15539940.55340.55
4126431-12643132.99432.99
5164691-16469142.97842.98
6127337-12733733.23033.23
10min1287252-28725274.96276.947.7275.0277.007.72
2296443-29644377.36177.42
3315970-31597082.45682.52
4292844-29284476.42176.48
5319740-31974083.44083.51
6256656-25665666.97867.03
15min1338720-33872088.39390.475.2788.5890.665.27
2356477-35647793.02793.22
3353504-35350492.25192.46
4363587-36358794.88395.06
5354384-35438492.48192.69
6313327-31332781.76781.93
20min1359927-35992793.92794.432.0894.2694.772.09
2366200-36620095.56595.91
3361547-36154794.35094.71
4371438-37143896.93197.27
5362978-36297894.72495.09
6348936-34893691.05991.36
30min1369049-36904996.30896.230.8396.8096.720.82
2371225-37122596.87697.38
3366459-36645995.63296.15
4372434-37243497.19197.69
5364144-36414495.02895.55
6369121-36912196.32796.78
45min1369870-36987096.52296.460.8297.1797.120.80
2371518-37151896.95297.62
3368118-36811896.06596.74
4372456-37245697.19797.86
5364294-36429495.06795.75
6371499-37149996.94797.56
60min1368804-36880496.24496.240.8397.0697.060.80
2371498-37149896.94797.77
3367490-36749095.90196.74
4370948-37094896.80497.63
5363416-36341694.83895.68
6370581-37058196.70897.48
极限1368427-36842796.14696.050.8897.1297.030.85
2370776-37077696.75997.75
3367125-36712595.80696.80
4368846-36884696.25597.24
5362208-36220894.52395.52
6370908-37090896.79397.73
非奈利酮片项目信息
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FN-706-231101对照品来源自制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1000
标示量(mg)10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%
111.143851263852413851923853413852143852230.03
211.203851173849983850580.03
单位质量响应值RSD%判断
34580.1634380.180.42数据可信
供试品溶液-24070901批-pH4.5(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1323772-32377284.51284.853.1684.5184.853.16
2321440-32144083.90383.90
3335618-33561887.60487.60
4329345-32934585.96685.97
5307219-30721980.19180.19
6332968-33296886.91286.91
10min1374550-37455097.76697.330.9897.9197.470.99
2371848-37184897.06097.20
3376050-37605098.15798.30
4375931-37593198.12698.27
5366293-36629395.61095.74
6372572-37257297.24997.39
15min1382790-38279099.91799.941.69100.22100.241.69
2374274-37427497.69498.00
3393184-393184102.630102.94
4385572-385572100.643100.95
5378276-37827698.73899.03
6383076-38307699.991100.30
20min1386807-386807100.965101.341.41101.44101.811.41
2385490-385490100.621101.09
3398316-398316103.969104.45
4388959-388959101.527102.00
5382109-38210999.739100.20
6387709-387709101.200101.67
30min1387593-387593101.170102.181.38101.81102.821.38
2390767-390767101.999102.63
3401353-401353104.762105.42
4392612-392612102.480103.12
5386035-386035100.764101.39
6390321-390321101.882102.52
45min1382863-38286399.936102.241.65100.74103.051.65
2393971-393971102.835103.64
3401424-401424104.780105.61
4393597-393597102.737103.55
5386615-386615100.915101.71
6391696-391696102.241103.05
60min1382657-38265799.882102.191.59100.86103.181.58
2393198-393198102.633103.61
3400996-400996104.669105.67
4393034-393034102.590103.58
5387282-387282101.089102.05
6391934-391934102.303103.29
极限1378748-37874898.861101.851.94100.00103.001.94
2393714-393714102.768103.91
3400824-400824104.624105.80
4391656-391656102.231103.39
5385038-385038100.503101.63
6391250-391250102.125103.28
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