美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222063192065702064942063442062442063940.07
219.032053872055202054540.05
单位质量响应值RSD%判断
10738.5010796.320.38数据可信
供试品溶液-2023082021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%
5min11397-13970.6800.627.590.680.627.71
21174-11740.5710.57
31357-13570.6600.66
41228-12280.5980.60
51179-11790.5740.57
61337-13370.6510.65
10min11611-16110.7840.777.940.790.777.79
21525-15250.7420.75
31732-17320.8430.85
41520-15200.7400.75
51381-13810.6720.68
61669-16690.8120.82
15min11612-16120.7850.787.080.800.807.41
21748-17480.8510.87
31704-17040.8290.85
41499-14990.7300.74
51587-15870.7720.79
61455-14550.7080.72
20min11630-16300.7930.834.840.820.854.55
21588-15880.7730.80
31819-18190.8850.91
41721-17210.8380.86
51715-17150.8350.86
61740-17400.8470.87
30min11891-18910.9200.837.910.950.877.34
21613-16130.7850.82
31636-16360.7960.83
41864-18640.9070.94
51719-17190.8370.87
61565-15650.7620.80
45min11711-17110.8330.864.960.880.904.79
21857-18570.9040.95
31751-17510.8520.90
41714-17140.8340.88
51886-18860.9180.96
61669-16690.8120.85
60min11976-19760.9620.934.281.010.983.96
21826-18260.8890.94
31842-18420.8960.95
41972-19720.9601.01
51998-19980.9721.02
61834-18340.8930.94
极限11937-19370.9430.935.951.010.995.61
21914-19140.9310.99
31876-18760.9130.98
41867-18670.9090.97
51748-17480.8510.91
62095-20951.0201.08
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222051442048002052552048672050422050220.10
219.032040502038522039510.07
单位质量响应值RSD%判断
10667.1210717.340.34数据可信
供试品溶液-t2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%
5min11404-14040.6880.6710.040.690.679.80
21276-12760.6250.63
31330-13300.6520.65
41392-13920.6820.68
51613-16130.7910.79
61219-12190.5970.60
10min11532-15320.7510.777.400.760.787.06
21745-17450.8550.86
31516-15160.7430.75
41553-15530.7610.77
51401-14010.6870.70
61630-16300.7990.81
15min11891-18910.9270.847.320.940.867.06
21701-17010.8340.85
31594-15940.7810.80
41861-18610.9120.93
51670-16700.8180.83
61614-16140.7910.81
20min11716-17160.8410.865.430.870.895.29
21861-18610.9120.94
31778-17780.8710.90
41885-18850.9240.95
51641-16410.8040.83
61701-17010.8340.86
30min11732-17320.8490.905.980.880.945.92
21729-17290.8470.88
31783-17830.8740.91
41962-19620.9621.00
51874-18740.9180.95
61972-19720.9661.00
45min11944-19440.9530.904.471.000.954.60
21732-17320.8490.89
31808-18080.8860.93
41936-19360.9491.00
51814-18140.8890.93
61821-18210.8920.94
60min11967-19670.9640.964.221.021.013.97
21786-17860.8750.93
32011-20110.9861.04
41970-19700.9651.02
51964-19640.9631.02
61993-19930.9771.03
极限11959-19590.9600.983.181.031.043.35
21935-19350.9481.01
31938-19380.9501.01
42076-20761.0171.09
52064-20641.0121.08
61972-19720.9661.03
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.222056502053552055972056862066202057820.24
219.032001862008242005050.23
单位质量响应值RSD%判断
10706.6610536.261.14数据可信
供试品溶液-2023082121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%
5min11103-11030.5440.6314.700.540.6315.17
21374-13740.6780.68
31036-10360.5110.51
41473-14730.7270.73
51222-12220.6030.60
61470-14700.7250.73
10min11546-15460.7630.727.070.770.727.25
21601-16010.7900.80
31447-14470.7140.72
41381-13810.6810.69
51331-13310.6570.66
61408-14080.6950.70
15min11661-16610.8200.758.590.830.778.48
21630-16300.8040.82
31482-14820.7310.74
41411-14110.6960.71
51636-16360.8070.82
61354-13540.6680.68
20min11746-17460.8610.786.480.890.816.50
21431-14310.7060.73
31636-16360.8070.83
41583-15830.7810.80
51568-15680.7740.80
61561-15610.7700.79
30min11821-18210.8980.834.310.930.874.18
21690-16900.8340.87
31612-16120.7950.83
41645-16450.8120.84
51662-16620.8200.85
61714-17140.8460.88
45min11650-16500.8140.878.170.860.917.49
21607-16070.7930.84
31741-17410.8590.90
41827-18270.9010.94
52009-20090.9911.03
61724-17240.8510.89
60min11826-18260.9010.874.770.950.924.57
21909-19090.9420.99
31730-17300.8540.90
41688-16880.8330.88
51748-17480.8620.91
61705-17050.8410.89
极限11763-17630.8700.873.030.930.932.77
21808-18080.8920.95
31702-17020.8400.90
41848-18480.9120.97
51727-17270.8520.91
61789-17890.8830.94
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