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%
112.342587092585012581542583872581792583860.09
212.372585342578612581980.19
单位质量响应值RSD%判断
20938.9020872.920.23数据可信
供试品溶液-2025091721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%
5min114570-145705.5725.9245.055.575.9245.02
28334-83343.1873.19
323791-237919.0989.10
420422-204227.8097.81
56394-63942.4452.45
619388-193887.4147.41
10min134114-3411413.04513.8213.3913.0513.8213.38
231636-3163612.09812.10
342256-4225616.15916.16
438654-3865414.78114.78
530251-3025111.56811.57
639917-3991715.26415.26
15min144480-4448017.00918.158.3917.0118.158.39
244564-4456417.04117.04
352561-5256120.09920.10
450162-5016219.18219.18
542860-4286016.39016.39
650197-5019719.19519.20
20min153731-5373120.54721.205.7320.5521.205.73
252820-5282020.19820.20
359453-5945322.73522.73
457549-5754922.00722.01
551526-5152619.70419.70
657597-5759722.02522.03
30min164338-6433824.60325.073.0624.6025.073.06
263205-6320524.17024.17
368035-6803526.01726.02
466926-6692625.59325.59
563822-6382224.40624.41
666971-6697125.61025.61
45min174445-7444528.46828.701.6928.4728.701.68
274534-7453428.50228.50
377128-7712829.49429.49
475513-7551328.87628.88
573397-7339728.06728.07
675330-7533028.80628.81
极限185632-8563232.74632.650.5832.7532.650.58
285597-8559732.73232.73
386092-8609232.92232.92
485070-8507032.53132.53
584696-8469632.38832.39
685225-8522532.59032.59
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%
112.342591212582632591312580272578372584760.24
212.372600692613252606970.35
单位质量响应值RSD%判断
20946.1921074.940.44数据可信
供试品溶液-2025091721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%
5min111881-118814.5215.0047.834.525.0047.85
216846-168466.4106.41
34652-46521.7701.77
423097-230978.7888.79
512307-123074.6834.68
69989-99893.8013.80
10min132276-3227612.28112.5324.7612.2812.5224.76
237151-3715114.13614.14
323269-232698.8548.85
444689-4468917.00417.00
535789-3578913.61813.62
624333-243339.2599.26
15min142402-4240216.13416.9714.6916.1316.9714.69
248297-4829718.37718.38
336992-3699214.07514.08
454196-5419620.62120.62
547276-4727617.98817.99
638375-3837514.60214.60
20min150367-5036719.16520.059.6719.1620.059.67
254905-5490520.89120.89
347149-4714917.94017.94
460423-6042322.99122.99
555305-5530521.04321.04
647987-4798718.25918.26
30min160342-6034222.96023.756.8922.9623.746.88
264060-6406024.37524.37
357111-5711121.73121.73
468765-6876526.16526.16
564980-6498024.72524.72
659200-5920022.52522.53
45min170197-7019726.71027.643.4726.7127.643.46
272737-7273727.67627.68
370426-7042626.79726.80
476620-7662029.15429.15
574483-7448328.34128.34
671396-7139627.16627.17
极限181050-8105030.83931.601.9330.8431.601.92
282021-8202131.20931.21
382346-8234631.33231.33
485211-8521132.42332.42
584628-8462832.20132.20
682969-8296931.57031.57
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