替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1112.58892388266884688859088569885630.27
2112.78767288058878650.32
单位质量响应值RSD%判断
787.23779.640.69数据可信
供试品溶液-25050601批-pH6.8(内含2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172218-7221881.63882.275.0581.6482.275.04
266187-6618774.82074.82
376098-7609886.02486.02
471808-7180881.17581.17
575329-7532985.15585.15
675027-7502784.81384.81
10min181300-8130091.90590.360.9892.0490.500.98
279711-7971190.10890.23
380365-8036590.84890.99
479222-7922289.55689.69
579695-7969590.09090.23
679314-7931489.66089.80
15min182700-8270093.48792.520.9193.7892.810.91
282511-8251193.27493.55
382068-8206892.77393.07
480855-8085591.40291.69
581809-8180992.48092.77
681111-8111191.69191.98
20min183469-8346994.35793.590.8194.8094.030.81
282981-8298193.80594.24
383070-8307093.90594.35
482033-8203392.73393.17
583309-8330994.17694.62
681889-8188992.57093.01
30min184560-8456095.59094.880.8796.1995.480.86
284300-8430095.29695.88
383760-8376094.68595.29
483392-8339294.26994.86
584734-8473495.78796.39
682869-8286993.67894.28
45min185347-8534796.48095.740.9897.2496.500.98
285079-8507996.17796.92
384456-8445695.47296.24
484332-8433295.33296.08
585599-8559996.76497.53
683339-8333994.21094.96
60min185762-8576296.94996.280.8597.8797.190.85
285604-8560496.77097.68
384805-8480595.86796.79
484951-8495196.03296.94
585892-8589297.09698.02
683997-8399794.95395.86
极限186442-8644297.71796.961.1098.8098.031.09
286424-8642497.69798.76
385293-8529396.41897.50
485645-8564596.81697.88
586641-8664197.94299.03
684170-8417095.14996.22
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1112.58821288213881178802488196881520.10
2112.78819888262882300.06
单位质量响应值RSD%判断
783.57782.870.07数据可信
供试品溶液-25050801批-pH6.8(内含2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min173495-7349583.10285.694.9883.1085.694.98
276135-7613586.08786.09
379476-7947689.86489.86
480281-8028190.77590.77
570165-7016579.33679.34
675142-7514284.96484.96
10min182534-8253493.32293.201.7593.4693.341.75
279936-7993690.38590.53
383215-8321594.09294.24
484299-8429995.31895.47
582209-8220992.95593.09
682353-8235393.11793.26
15min184649-8464995.71494.811.6996.0195.111.68
281165-8116591.77492.07
384587-8458795.64395.95
485077-8507796.19896.51
583700-8370094.64194.93
683915-8391594.88495.18
20min185205-8520596.34295.721.2096.8096.171.20
282678-8267893.48593.93
384950-8495096.05496.52
485456-8545696.62697.10
585088-8508896.21096.65
684533-8453395.58296.04
30min185945-8594597.17996.680.8897.7997.300.88
284072-8407295.06195.66
385763-8576396.97397.60
485849-8584997.07097.70
586063-8606397.31297.92
685341-8534196.49697.11
45min186349-8634997.63697.280.6398.4198.060.63
285034-8503496.14996.91
386184-8618497.44998.24
486188-8618897.45498.25
586562-8656297.87798.64
685894-8589497.12197.90
60min186660-8666097.98797.620.5598.9398.560.55
285471-8547196.64397.56
386371-8637197.66198.61
486258-8625897.53398.49
586837-8683798.18899.12
686419-8641997.71598.65
极限186921-8692198.28398.400.4499.3899.500.43
286821-8682198.16999.25
386697-8669798.02999.14
486748-8674898.08799.21
587283-8728398.69299.79
687670-8767099.129100.23
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