多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
111.012660372667532673142666282685262670520.36
211.112745922755312750620.25
单位质量响应值RSD%判断
24255.4024758.061.46数据可信
供试品溶液-3788B批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12665-26650.9781.2133.850.981.2233.83
22060-20600.7560.76
34788-47881.7571.76
43000-30001.1011.10
54609-46091.6911.69
62736-27361.0041.00
10min14626-46261.6971.616.911.701.616.93
23819-38191.4011.40
34609-46091.6911.69
44294-42941.5761.58
54524-45241.6601.66
64414-44141.6201.62
15min15631-56312.0661.968.162.071.968.15
24570-45701.6771.68
35471-54712.0072.01
45798-57982.1272.13
55414-54141.9861.99
65141-51411.8861.89
20min15712-57122.0962.108.052.102.108.07
25431-54311.9932.00
35768-57682.1162.13
45803-58032.1292.14
56468-64682.3732.38
65082-50821.8651.87
30min15607-56072.0572.065.132.072.075.18
25491-54912.0152.02
36076-60762.2292.24
45791-57912.1252.14
55234-52341.9201.93
65514-55142.0232.03
45min14923-49231.8062.117.791.822.127.82
25767-57672.1162.13
35994-59942.1992.22
46243-62432.2912.31
55686-56862.0862.10
65816-58162.1342.15
60min15587-55872.0502.167.272.072.187.11
26562-65622.4082.42
35967-59672.1892.21
45916-59162.1712.19
55940-59402.1792.20
65289-52891.9411.96
90min16650-66502.4402.1410.392.462.1610.29
26327-63272.3212.34
35410-54101.9852.01
45674-56742.0822.10
55967-59672.1892.21
64994-49941.8321.85
120min15854-58542.1482.028.832.172.048.61
25938-59382.1792.20
34611-46111.6921.72
45501-55012.0182.04
55391-53911.9782.00
65750-57502.1102.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限14562-45621.6741.909.391.701.929.30
25034-50341.8471.88
35843-58432.1442.17
45658-56582.0762.11
54985-49851.8291.86
64920-49201.8051.83
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所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250
标示量(mg)40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%
111.012729562750842742452740012749262742420.31
211.112736302736302736300.00
单位质量响应值RSD%判断
24908.4524629.160.80数据可信
供试品溶液-3788B批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133659-3365912.21912.4120.4812.2212.4020.48
229811-2981110.82210.82
339089-3908914.19014.19
422683-226838.2348.23
541223-4122314.96414.96
638605-3860514.01414.01
10min159673-5967321.66222.1310.3721.6822.1510.38
257593-5759320.90720.92
369274-6927425.14725.17
451974-5197418.86718.88
566987-6698724.31724.34
660351-6035121.90821.93
15min174576-7457627.07226.994.0827.1327.054.10
272581-7258126.34826.40
378887-7888728.63728.70
470541-7054125.60725.65
576709-7670927.84627.91
672876-7287626.45526.51
20min183064-8306430.15330.472.8930.2530.572.91
282823-8282330.06530.16
387564-8756431.78631.90
482409-8240929.91530.00
586289-8628931.32431.44
681442-8144229.56429.67
30min192206-9220633.47234.111.8733.6234.261.86
294881-9488134.44334.59
396134-9613434.89735.06
495507-9550734.67034.81
592706-9270633.65333.82
692288-9228833.50133.65
45min197787-9778735.49835.206.1935.7135.416.15
293893-9389334.08434.29
387146-8714631.63531.86
497227-9722735.29435.49
5104234-10423437.83838.06
6101478-10147836.83737.05
60min1103684-10368437.63835.687.4737.9035.957.41
287774-8777431.86332.12
392510-9251033.58233.86
4104013-10401337.75838.01
595929-9592934.82335.11
6105897-10589738.44238.71
90min1108848-10884839.51335.4216.9539.8435.7416.81
280233-8023329.12529.44
3107888-10788839.16439.50
4108081-10808139.23439.55
5107671-10767139.08539.43
672667-7266726.37926.71
120min1111926-11192640.63034.8019.7941.0335.1919.56
2102916-10291637.35937.72
3104104-10410437.79138.19
4111803-11180340.58540.97
567222-6722224.40224.81
677198-7719828.02428.40
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限159746-5974621.68834.7330.5522.1535.1830.13
290380-9038032.80933.23
365258-6525823.68924.15
4111863-11186340.60741.06
5112812-11281240.95241.40
6134019-13401948.65049.08
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