坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.257759177317774737737377520774550.15
216.287914679135791400.01
单位质量响应值RSD%判断
4766.464861.181.40数据可信
供试品溶液-24032201-1批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129989-2998934.97637.0414.3234.9837.0414.32
224323-2432328.36828.37
336425-3642542.48242.48
436239-3623942.26542.27
530557-3055735.63835.64
633037-3303738.53138.53
10min157085-5708566.57767.004.5066.9767.414.55
252517-5251761.25061.57
359939-5993969.90670.38
458673-5867368.43068.90
558258-5825867.94668.34
658212-5821267.89268.32
15min169762-6976281.36280.762.1582.4981.922.20
266922-6692278.05079.05
371059-7105982.87584.12
468338-6833879.70280.93
569049-6904980.53181.68
670365-7036582.06683.25
20min174784-7478487.22086.641.6489.2588.691.64
273427-7342785.63787.50
375646-7564688.22590.39
472714-7271484.80586.92
575542-7554288.10490.15
673601-7360185.84087.93
30min178938-7893892.06492.071.2795.0795.091.17
279887-7988793.17195.99
378519-7851991.57694.73
477368-7736890.23393.29
580131-8013193.45696.48
678838-7883891.94895.00
45min178625-7862591.69991.591.7395.7295.621.65
278978-7897892.11195.96
378688-7868891.77395.94
475893-7589388.51392.57
579689-7968992.94097.00
679307-7930792.49596.56
60min178769-7876991.86791.292.7296.9196.352.53
280372-8037293.73798.61
377176-7717690.00995.20
474571-7457186.97192.02
579871-7987193.15298.25
678910-7891092.03297.13
极限178180-7818091.18090.082.2497.2496.152.08
278981-7898192.11498.03
376236-7623688.91395.10
474412-7441286.78692.80
578629-7862991.70497.83
676972-7697289.77195.89
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.257922579205793027912678865791450.22
216.288090980944809260.04
单位质量响应值RSD%判断
4870.464970.881.45数据可信
供试品溶液-24032201-1批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116140-1614018.41515.0718.2818.4215.0818.29
210844-1084412.37312.37
311515-1151513.13813.14
415986-1598618.24018.24
513628-1362815.54915.55
611156-1115612.72912.73
10min131600-3160036.05533.859.7936.2634.029.83
224561-2456128.02328.16
329298-2929833.42833.57
432510-3251037.09337.30
531418-3141835.84736.02
628627-2862732.66332.80
15min142787-4278748.81947.547.4349.4248.087.46
235608-3560840.62841.08
342057-4205747.98648.50
444002-4400250.20550.82
543721-4372149.88450.46
641808-4180847.70248.21
20min149879-4987956.91056.735.4158.0657.805.44
244384-4438450.64151.54
350939-5093958.12059.17
451221-5122158.44259.61
550289-5028957.37858.50
651592-5159258.86559.90
30min162096-6209670.85072.113.9772.6373.813.99
258812-5881267.10368.57
365741-6574175.00876.70
463410-6341072.34974.17
563978-6397872.99774.76
665159-6515974.34476.03
45min170530-7053080.47381.483.5483.0483.993.45
269959-6995979.82182.03
373735-7373584.12986.66
471202-7120281.23983.87
568110-6811077.71180.29
674957-7495785.52488.04
60min170546-7054680.49185.876.0283.9589.285.90
269479-6947979.27382.37
379310-7931090.49093.95
475150-7515085.74489.27
576393-7639387.16290.60
680670-8067092.04295.51
极限177029-7702987.88889.942.1892.2494.302.11
279036-7903690.17894.15
381013-8101392.43396.90
477339-7733988.24192.72
577832-7783288.80493.21
680691-8069192.06696.55
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