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%
112.152473612473412470242469532474222472200.09
212.172474992476912475950.06
单位质量响应值RSD%判断
20347.3320344.700.01数据可信
供试品溶液-2025091622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%
5min110192-101924.0053.3241.284.003.3241.28
28800-88003.4583.46
312172-121724.7834.78
48854-88543.4793.48
58751-87513.4383.44
61863-18630.7320.73
10min129271-2927111.50110.5914.4011.5010.5914.39
226427-2642710.38410.38
332147-3214712.63112.63
426591-2659110.44810.45
526891-2689110.56610.57
620427-204278.0268.03
15min141576-4157616.33615.488.2316.3415.488.24
239371-3937115.47015.47
342902-4290216.85716.86
439421-3942115.48915.49
539658-3965815.58315.58
633448-3344813.14213.14
20min149689-4968919.52418.886.5919.5218.886.60
248489-4848919.05219.05
351285-5128520.15120.15
448914-4891419.21919.22
547900-4790018.82118.82
642052-4205216.52316.52
30min161654-6165424.22523.197.6224.2323.197.62
259651-5965123.43823.44
362701-6270124.63724.64
461080-6108024.00024.00
558724-5872423.07423.07
650319-5031919.77119.77
45min173270-7327028.78928.203.0428.7928.203.04
271537-7153728.10828.11
374008-7400829.07929.08
472959-7295928.66728.67
570802-7080227.82027.82
668024-6802426.72826.73
极限186069-8606933.81833.213.0633.8233.213.07
283894-8389432.96432.96
387903-8790334.53934.54
485670-8567033.66233.66
583076-8307632.64232.64
680548-8054831.64931.65
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%
112.152489132486802488232485902483842486780.09
212.172505722502522504120.10
单位质量响应值RSD%判断
20467.3320576.170.38数据可信
供试品溶液-2025091721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%
5min16165-61652.4023.7719.052.403.7719.07
210977-109774.2764.28
310172-101723.9633.96
411149-111494.3434.34
510315-103154.0184.02
69290-92903.6193.62
10min115738-157386.1319.6018.376.139.6018.39
226618-2661810.36910.37
326518-2651810.33010.33
425482-254829.9279.93
528509-2850911.10611.11
625040-250409.7559.75
15min127286-2728610.63014.0812.6410.6314.0812.65
237226-3722614.50214.50
338530-3853015.01015.01
436927-3692714.38514.39
540420-4042015.74615.75
636501-3650114.21914.22
20min137638-3763814.66217.638.6414.6617.638.64
246583-4658318.14718.15
346707-4670718.19518.20
446423-4642318.08518.08
548861-4886119.03419.03
645312-4531217.65217.65
30min150158-5015819.54022.426.5819.5422.426.58
259334-5933423.11423.11
358805-5880522.90822.91
459492-5949223.17623.18
560423-6042323.53823.54
657095-5709522.24222.24
45min164166-6416624.99727.194.2425.0027.194.24
271476-7147627.84427.84
370493-7049327.46127.46
471831-7183127.98227.98
571815-7181527.97627.98
669042-6904226.89626.90
极限177724-7772430.27832.263.2730.2832.263.27
284576-8457632.94732.95
383081-8308132.36532.37
485147-8514733.17033.17
584125-8412532.77232.77
682285-8228532.05532.05
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%
112.152492772493212489552495852493022492880.09
212.172516982518922517950.06
单位质量响应值RSD%判断
20517.5320689.810.60数据可信
供试品溶液-2025091722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%
5min116949-169496.5765.0435.946.585.0435.99
211297-112974.3834.38
311274-112744.3744.37
45749-57492.2312.23
518854-188547.3167.32
613873-138735.3835.38
10min134791-3479113.49912.0923.6913.5012.0923.68
233499-3349912.99813.00
330420-3042011.80311.80
416797-167976.5176.52
537352-3735214.49314.49
634051-3405113.21213.21
15min145873-4587317.79916.4516.4917.8016.4416.49
246086-4608617.88217.88
341606-4160616.14416.14
428739-2873911.15111.15
547605-4760518.47118.47
644405-4440517.23017.23
20min154006-5400620.95519.7111.9620.9619.7211.96
253477-5347720.75020.75
350060-5006019.42419.42
438967-3896715.12015.12
555535-5553521.54821.55
652806-5280620.49020.49
30min164502-6450225.02824.206.7225.0324.206.72
265223-6522325.30825.31
360624-6062423.52323.52
454554-5455421.16821.17
565067-6506725.24725.25
664272-6427224.93924.94
45min174694-7469428.98228.583.9828.9828.583.98
276450-7645029.66429.66
371885-7188527.89227.89
468560-6856026.60226.60
575211-7521129.18329.18
675191-7519129.17529.18
极限185267-8526733.08533.271.7033.0833.261.69
287815-8781534.07434.07
385962-8596233.35533.35
483525-8352532.40932.41
585230-8523033.07133.07
686618-8661833.60933.61
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