美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.122671382671522668992678702661552670430.24
218.092667392675152671270.21
单位质量响应值RSD%判断
14737.4714766.560.14数据可信
供试品溶液-24111901批-醋酸盐缓冲液(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%
5min1-0.0000.13109.650.000.13109.66
2-0.0000.00
3698-6980.2650.26
4670-6700.2540.25
5723-7230.2740.27
6-0.0000.00
10min1520-5200.1970.3277.680.200.3277.65
22199-21990.8340.83
3664-6640.2520.25
4604-6040.2290.23
5534-5340.2030.20
6590-5900.2240.22
15min1534-5340.2030.237.930.200.249.23
2634-6340.2410.25
3672-6720.2550.26
4615-6150.2330.24
5581-5810.2200.22
6639-6390.2420.24
20min1664-6640.2520.247.000.250.247.20
2677-6770.2570.26
3639-6390.2420.25
4552-5520.2090.21
5633-6330.2400.24
6647-6470.2450.25
30min1687-6870.2610.253.800.260.264.22
2676-6760.2560.26
3710-7100.2690.28
4637-6370.2420.25
5653-6530.2480.25
6662-6620.2510.26
45min1802-8020.3040.286.970.310.296.37
2776-7760.2940.30
3709-7090.2690.28
4663-6630.2520.26
5728-7280.2760.28
6780-7800.2960.30
60min1717-7170.2720.286.530.280.285.33
2774-7740.2940.30
3716-7160.2720.28
4743-7430.2820.29
5654-6540.2480.26
6785-7850.2980.30
极限1737-7370.2800.299.690.290.309.43
2748-7480.2840.30
3794-7940.3010.31
4726-7260.2750.28
5683-6830.2590.27
6896-8960.3400.35
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.122672562668402679292650792657952665800.43
218.092662282661692661980.02
单位质量响应值RSD%判断
14711.9214715.200.02数据可信
供试品溶液-24112001批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.2080.210.000.2080.13
2705-7050.2680.27
3650-6500.2470.25
4968-9680.3680.37
5-0.0000.00
6815-8150.3100.31
10min1554-5540.2110.3177.730.210.3176.89
2624-6240.2370.24
3536-5360.2040.21
4548-5480.2080.21
5527-5270.2000.20
62108-21080.8020.80
15min1547-5470.2080.3394.080.210.3492.87
22539-25390.9660.97
3508-5080.1930.20
4543-5430.2070.21
5553-5530.2100.21
6529-5290.2010.21
20min1523-5230.1990.3597.810.200.3596.76
2515-5150.1960.20
3657-6570.2500.25
4568-5680.2160.22
52767-27671.0531.05
6519-5190.1970.20
30min1699-6990.2660.3987.600.270.4086.37
2738-7380.2810.29
3624-6240.2370.24
4635-6350.2420.25
5575-5750.2190.23
62834-28341.0781.09
45min1651-6510.2480.3986.340.250.4084.61
2621-6210.2360.25
3736-7360.2800.29
4699-6990.2660.27
52845-28451.0821.09
6631-6310.2400.25
60min1644-6440.2450.263.430.250.274.69
2692-6920.2630.28
3652-6520.2480.26
4698-6980.2660.27
5688-6880.2620.28
6688-6880.2620.28
极限1742-7420.2820.274.340.290.284.30
2739-7390.2810.29
3687-6870.2610.27
4730-7300.2780.29
5732-7320.2780.30
6667-6670.2540.27
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