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%
112.341265621263121265991264911265911265110.10
212.371273961260651267300.75
单位质量响应值RSD%判断
10252.1110244.950.05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%
5min15828-58284.5464.1734.604.554.1734.62
26362-63624.9634.96
31696-16961.3231.32
46497-64975.0685.07
55252-52524.0974.10
66427-64275.0135.01
10min125028-2502819.52319.618.5619.5219.618.55
226775-2677520.88620.89
321111-2111116.46816.47
427128-2712821.16121.16
525196-2519619.65419.65
625632-2563219.99419.99
15min133883-3388326.43126.985.3326.4326.985.34
236376-3637628.37528.38
331873-3187324.86324.86
436959-3695928.83028.83
534121-3412126.61626.62
634320-3432026.77126.77
20min139650-3965030.92931.644.2630.9331.644.26
242320-4232033.01233.01
338311-3831129.88529.88
442894-4289433.46033.46
540285-4028531.42431.42
639933-3993331.15031.15
30min147615-4761537.14237.843.1537.1437.843.15
250092-5009239.07439.07
346641-4664136.38236.38
450554-5055439.43539.43
548464-4846437.80537.80
647698-4769837.20737.21
45min155777-5577743.50944.071.6243.5144.081.61
257092-5709244.53544.53
356032-5603243.70843.71
457970-5797045.22045.22
556585-5658544.13944.14
655557-5555743.33743.34
极限167450-6745052.61553.120.8352.6153.120.83
267986-6798653.03353.03
368531-6853153.45853.46
468841-6884153.70053.70
568297-6829753.27553.28
667499-6749952.65352.65
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%
112.341266541268531268861266801268071267760.09
212.371263691262011262850.10
单位质量响应值RSD%判断
10273.5810208.970.45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%
5min15827-58274.5494.7833.404.554.7833.40
28642-86426.7466.75
33834-38342.9932.99
48615-86156.7256.72
54889-48893.8163.82
64909-49093.8323.83
10min124449-2444919.08518.4414.3319.0918.4414.33
226745-2674520.87820.88
323380-2338018.25118.25
427232-2723221.25821.26
521769-2176916.99316.99
618123-1812314.14714.15
15min132539-3253925.40025.2211.9925.4025.2211.98
235956-3595628.06828.07
331398-3139824.51024.51
436593-3659328.56528.56
531522-3152224.60624.61
625846-2584620.17620.18
20min139339-3933930.70930.428.4430.7130.428.44
242108-4210832.87032.87
337567-3756729.32529.33
442782-4278233.39633.40
538202-3820229.82129.82
633783-3378326.37126.37
30min146707-4670736.46036.845.9936.4636.846.00
250125-5012539.12839.13
345282-4528235.34835.35
450829-5082939.67839.68
546781-4678136.51836.52
643442-4344233.91133.91
45min153592-5359241.83543.003.9541.8343.003.95
257465-5746544.85844.86
353270-5327041.58341.58
457692-5769245.03545.04
555660-5566043.44943.45
652796-5279641.21341.21
极限165859-6585951.41052.173.6751.4152.173.66
268593-6859353.54553.54
365802-6580251.36651.37
469566-6956654.30454.30
568285-6828553.30453.30
662920-6292049.11649.12
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