他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.341263641263821258591263671262841262510.18
212.371260691264381262540.21
单位质量响应值RSD%判断
10231.0410206.470.18数据可信
供试品溶液-2025091522批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13922-39223.0685.5024.253.075.5024.25
27124-71245.5735.57
38522-85226.6676.67
47975-79756.2396.24
56445-64455.0425.04
68218-82186.4296.43
10min124540-2454019.19820.855.4419.2020.855.44
227306-2730621.36221.36
326712-2671220.89820.90
426361-2636120.62320.62
526060-2606020.38720.39
628921-2892122.62622.63
15min134502-3450226.99227.512.9226.9927.512.92
235781-3578127.99227.99
334969-3496927.35727.36
434682-3468227.13327.13
534119-3411926.69226.69
636912-3691228.87728.88
20min140080-4008031.35632.484.3031.3632.484.29
240789-4078931.91031.91
344281-4428134.64234.64
441981-4198132.84332.84
539421-3942130.84030.84
642528-4252833.27133.27
30min147946-4794637.50938.162.5837.5138.162.58
248443-4844337.89837.90
349456-4945638.69138.69
449518-4951838.73938.74
546916-4691636.70436.70
650386-5038639.41839.42
45min154773-5477342.85044.272.5242.8544.272.52
256509-5650944.20944.21
357419-5741944.92044.92
457385-5738544.89444.89
555067-5506743.08043.08
658383-5838345.67545.67
极限165603-6560351.32353.422.3151.3253.422.31
268857-6885753.86953.87
369149-6914954.09754.10
469116-6911654.07154.07
567202-6720252.57452.57
669772-6977254.58554.58
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.341263071261691258771258151265151261370.24
212.371264821267061265940.13
单位质量响应值RSD%判断
10221.8010233.950.09数据可信
供试品溶液-2025091621批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18534-85346.6704.23112.106.674.23112.11
2-0.0000.00
312418-124189.7069.71
411534-115349.0159.02
5-0.0000.00
6-0.0000.00
10min127045-2704521.13916.0940.2821.1416.0840.29
213937-1393710.89410.89
329313-2931322.91222.91
427952-2795221.84821.85
512410-124109.7009.70
612823-1282310.02310.02
15min135038-3503827.38724.2518.0827.3924.2618.08
225896-2589620.24120.24
336809-3680928.77128.77
436501-3650128.53028.53
525531-2553119.95619.96
626412-2641220.64420.64
20min140526-4052631.67629.5611.0631.6829.5611.06
233423-3342326.12426.12
342250-4225033.02433.02
441990-4199032.82132.82
534300-3430026.81026.81
634453-3445326.92926.93
30min147654-4765437.24836.216.8637.2536.216.86
242899-4289933.53133.53
350031-5003139.10639.11
449614-4961438.78038.78
544195-4419534.54434.54
643539-4353934.03134.03
45min156302-5630244.00743.004.1544.0143.004.15
252569-5256941.08941.09
357570-5757044.99845.00
457262-5726244.75844.76
553000-5300041.42641.43
653357-5335741.70541.71
极限168313-6831353.39553.332.2253.4053.332.22
266425-6642551.92051.92
370055-7005554.75754.76
469775-6977554.53854.54
566666-6666652.10852.11
668120-6812053.24553.24
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