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%
112.342589202588732583782583482591992587440.15
212.372580582581872581220.04
单位质量响应值RSD%判断
20967.9120866.770.35数据可信
供试品溶液-2025091622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%
5min121019-210198.0336.6239.808.036.6239.79
210484-104844.0074.01
327160-2716010.38010.38
419375-193757.4057.40
517360-173606.6356.63
68581-85813.2803.28
10min142445-4244516.22215.1014.9516.2215.1014.94
233694-3369412.87812.88
346608-4660817.81317.81
442121-4212116.09816.10
541216-4121615.75215.75
631032-3103211.86011.86
15min152962-5296220.24219.158.9320.2419.158.94
245407-4540717.35417.35
355353-5535321.15521.16
451716-5171619.76519.77
551303-5130319.60819.61
643928-4392816.78916.79
20min159327-5932722.67421.925.4622.6721.925.46
253979-5397920.63020.63
360799-6079923.23723.24
458413-5841322.32522.32
558630-5863022.40822.41
652987-5298720.25120.25
30min168135-6813526.04125.602.9726.0425.602.98
265074-6507424.87124.87
369560-6956026.58526.59
467256-6725625.70525.70
567604-6760425.83825.84
664217-6421724.54324.54
45min175964-7596429.03328.931.4829.0328.921.48
274370-7437028.42428.42
377348-7734829.56229.56
475600-7560028.89428.89
576277-7627729.15229.15
674534-7453428.48628.49
极限185242-8524232.57932.640.6832.5832.640.68
285391-8539132.63632.64
386214-8621432.95032.95
484852-8485232.43032.43
585902-8590232.83132.83
684742-8474232.38832.39
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%
112.342582352580152583462586012586632583720.11
212.372589922591192590560.04
单位质量响应值RSD%判断
20937.7620942.280.02数据可信
供试品溶液-2025091622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%
5min112285-122854.6907.9735.404.697.9735.42
220878-208787.9717.97
320148-201487.6927.69
431735-3173512.11612.12
526431-2643110.09110.09
613806-138065.2715.27
10min135006-3500613.36415.8412.7013.3615.8412.71
241067-4106715.67815.68
342687-4268716.29716.30
448583-4858318.54818.55
545442-4544217.34917.35
636099-3609913.78213.78
15min145413-4541317.33819.598.7817.3419.598.77
251180-5118019.53919.54
353156-5315620.29420.29
456691-5669121.64321.64
554811-5481120.92620.93
646633-4663317.80317.80
20min153262-5326220.33422.206.3020.3322.206.29
257121-5712121.80721.81
359718-5971822.79922.80
462454-6245423.84323.84
561435-6143523.45423.45
654951-5495120.97920.98
30min163225-6322524.13825.633.7624.1425.643.76
266818-6681825.51025.51
367553-6755325.79025.79
470032-7003226.73726.74
569532-6953226.54626.55
665706-6570625.08525.08
45min171703-7170327.37428.692.6327.3728.692.64
274405-7440528.40628.41
375357-7535728.77028.77
476863-7686329.34429.34
577154-7715429.45629.46
675418-7541828.79328.79
极限180642-8064230.78732.012.1230.7932.012.12
283314-8331431.80731.81
383846-8384632.01032.01
484843-8484332.39132.39
585696-8569632.71732.72
684714-8471432.34232.34
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