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%
118.672100862100402099582101292100412100510.04
218.632105782101872103820.14
单位质量响应值RSD%判断
11250.7211292.650.27数据可信
供试品溶液-12442082批-pH5.5csy
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11024-10240.5080.534.200.510.533.91
21109-11090.5510.55
31088-10880.5400.54
10min11347-13470.6690.660.790.670.660.88
21330-13300.6600.66
31329-13290.6600.66
15min11452-14520.7210.703.250.730.703.58
21398-13980.6940.70
31362-13620.6760.68
20min11537-15370.7630.743.290.770.752.79
21465-14650.7270.74
31443-14430.7170.73
30min11582-15820.7860.772.190.800.781.96
21538-15380.7640.78
31517-15170.7530.77
45min11741-17410.8640.852.170.880.871.77
21715-17150.8520.87
31668-16680.8280.85
60min11736-17360.8620.850.820.890.881.32
21714-17140.8510.87
31710-17100.8490.87
极限11779-17790.8830.871.200.910.901.29
21743-17430.8650.89
31742-17420.8650.89
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%
118.672124922115832115212115732116932117720.20
218.632116072116762116420.03
单位质量响应值RSD%判断
11342.9011360.280.11数据可信
供试品溶液-24040701批-pH5.5csy
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11241-12410.6120.604.300.610.603.88
21152-11520.5680.57
31244-12440.6130.61
10min11446-14460.7130.701.570.720.702.18
21403-14030.6920.69
31413-14130.6970.70
15min11483-14830.7310.752.400.740.752.03
21504-15040.7420.75
31553-15530.7660.77
20min11568-15680.7730.802.750.780.812.87
21644-16440.8110.82
31645-16450.8110.82
30min11727-17270.8510.872.340.870.892.35
21807-18070.8910.91
31755-17550.8650.88
45min11921-19210.9470.995.420.971.015.24
22127-21271.0491.07
31968-19680.9700.99
60min12056-20561.0141.053.121.041.073.28
22188-21881.0791.11
32118-21181.0441.07
极限12155-21551.0631.124.351.091.154.52
22333-23331.1501.18
32320-23201.1441.18
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%
118.672102182100222100842099682098662100320.07
218.632089602089992089800.02
单位质量响应值RSD%判断
11249.7111217.390.21数据可信
供试品溶液-12442082批-pH5.5lsy
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1895-8950.4460.476.250.450.476.19
21003-10030.5000.50
3912-9120.4540.45
10min11093-10930.5450.532.930.550.532.87
21066-10660.5310.53
31032-10320.5140.52
15min11142-11420.5690.563.910.570.574.45
21163-11630.5790.59
31078-10780.5370.54
20min11199-11990.5970.575.080.610.585.24
21161-11610.5780.59
31083-10830.5400.55
30min11256-12560.6260.612.960.640.623.34
21236-12360.6160.63
31186-11860.5910.60
45min11411-14110.7030.684.430.720.704.95
21408-14080.7020.72
31305-13050.6500.66
60min11532-15320.7630.735.050.780.754.71
21473-14730.7340.75
31384-13840.6900.71
极限11587-15870.7910.763.400.810.793.20
21536-15360.7650.79
31484-14840.7390.76
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%
118.672127162136752132942130362132292131900.17
218.632105852105182105520.03
单位质量响应值RSD%判断
11418.8511301.770.73数据可信
供试品溶液-24040701批-pH5.5lsy
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1835-8350.4110.438.170.410.438.06
2958-9580.4720.47
3835-8350.4110.41
10min1995-9950.4900.493.190.490.494.09
21021-10210.5030.51
3959-9590.4720.47
15min11045-10450.5150.502.300.520.512.28
21011-10110.4980.50
31000-10000.4930.50
20min11105-11050.5440.532.550.550.542.16
21065-10650.5250.53
31051-10510.5180.53
30min11129-11290.5560.553.450.570.563.10
21135-11350.5590.57
31065-10650.5250.54
45min11238-12380.6100.602.130.620.611.91
21190-11900.5860.60
31200-12000.5910.60
60min11275-12750.6280.612.290.650.632.75
21230-12300.6060.62
31221-12210.6020.62
极限11446-14460.7120.683.800.730.703.78
21367-13670.6730.69
31346-13460.6630.68
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