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%
118.002069582073482069252073272071122071340.10
218.042078002074832076420.11
单位质量响应值RSD%判断
11507.4411510.090.02数据可信
供试品溶液-12521472批-磷酸盐溶液(pH7.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14425-44252.1522.025.792.152.025.73
24151-41512.0192.02
34201-42012.0432.04
43697-36971.7981.80
54177-41772.0312.03
64214-42142.0492.05
10min18174-81743.9753.763.734.003.793.76
27546-75463.6703.69
37768-77683.7783.80
47342-73423.5713.59
57696-76963.7433.77
67910-79103.8473.87
15min113271-132716.4546.572.116.526.632.06
213168-131686.4046.47
313578-135786.6036.67
413982-139826.8006.86
513551-135516.5906.65
613486-134866.5586.62
20min116982-169828.2598.251.018.408.390.99
216924-169248.2308.36
317092-170928.3128.45
416683-166838.1138.25
517185-171858.3578.49
616968-169688.2528.39
30min128451-2845113.83613.881.6614.0714.121.63
228273-2827313.75013.98
328304-2830413.76514.00
428522-2852213.87114.10
529489-2948914.34114.57
628258-2825813.74213.97
45min138443-3844318.69518.860.9919.0819.240.96
238700-3870018.82019.20
338820-3882018.87919.26
438395-3839518.67219.05
538887-3888718.91119.30
639444-3944419.18219.56
60min150802-5080224.70624.570.6925.3025.160.69
250514-5051424.56625.15
350343-5034324.48325.08
449999-4999924.31524.90
550516-5051624.56725.17
650984-5098424.79425.39
极限156778-5677827.61227.290.9128.4828.160.89
255896-5589627.18328.04
356717-5671727.58228.45
455524-5552427.00227.86
555973-5597327.22028.09
655866-5586627.16828.04
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%
118.002074022070802074732074002070702072850.10
218.042065742062922064330.10
单位质量响应值RSD%判断
11515.8311443.070.45数据可信
供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12147-21471.0471.124.801.051.124.71
22294-22941.1181.12
32465-24651.2021.20
42324-23241.1331.13
52201-22011.0731.07
62299-22991.1211.12
10min12719-27191.3261.321.271.341.331.32
22732-27321.3321.34
32726-27261.3291.34
42645-26451.2901.30
52672-26721.3031.31
62709-27091.3211.33
15min12910-29101.4191.472.871.451.502.72
22909-29091.4181.45
33081-30811.5021.53
43100-31001.5111.54
53065-30651.4941.52
63052-30521.4881.52
20min13431-34311.6731.682.211.711.732.22
23494-34941.7041.75
33340-33401.6281.67
43475-34751.6941.74
53560-35601.7361.78
63413-34131.6641.71
30min14881-48812.3802.184.782.442.244.65
24365-43652.1282.19
34420-44202.1552.22
44530-45302.2092.27
54368-43682.1302.19
64290-42902.0922.15
45min15392-53922.6292.672.622.722.762.53
25420-54202.6432.73
35419-54192.6422.73
45767-57672.8122.90
55445-54452.6552.74
65419-54192.6422.73
60min16999-69993.4123.442.623.533.562.54
26903-69033.3663.48
36961-69613.3943.51
47393-73933.6053.72
57152-71523.4873.60
66947-69473.3873.50
极限17782-77823.7943.832.793.953.982.77
27590-75903.7013.85
37780-77803.7933.95
48243-82434.0194.18
57922-79223.8624.02
67802-78023.8043.96
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%
118.002072122074352076612073782070762073520.11
218.042064082064082064080.00
单位质量响应值RSD%判断
11519.5611441.690.48数据可信
供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1809-8090.3940.375.470.390.384.99
2690-6900.3360.34
3749-7490.3650.37
4779-7790.3800.38
5772-7720.3760.38
6790-7900.3850.39
10min11073-10730.5230.543.760.530.543.95
21084-10840.5280.53
31061-10610.5170.52
41176-11760.5730.58
51115-11150.5440.55
61097-10970.5350.54
15min11098-10980.5350.575.610.550.585.27
21194-11940.5820.59
31192-11920.5810.59
41214-12140.5920.60
51104-11040.5380.55
61268-12680.6180.63
20min11152-11520.5620.595.580.580.615.19
21222-12220.5960.61
31213-12130.5910.61
41302-13020.6350.65
51131-11310.5510.57
61279-12790.6240.64
30min11312-13120.6400.648.920.660.668.55
21163-11630.5670.59
31276-12760.6220.64
41472-14720.7180.74
51202-12020.5860.61
61393-13930.6790.70
45min11380-13800.6730.6612.240.700.6911.96
21296-12960.6320.66
31282-12820.6250.65
41294-12940.6310.66
51208-12080.5890.62
61675-16750.8170.85
60min11427-14270.6960.677.600.730.717.25
21414-14140.6890.73
31297-12970.6320.67
41489-14890.7260.77
51211-12110.5900.63
61441-14410.7030.74
极限11474-14740.7190.713.070.760.753.38
21437-14370.7010.74
31423-14230.6940.74
41487-14870.7250.77
51378-13780.6720.71
61494-14940.7280.78
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%
118.002068112073702069822074362074482072090.15
218.042066352067312066830.04
单位质量响应值RSD%判断
11511.6111456.930.34数据可信
供试品溶液-12521472批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11379-13790.6720.673.880.670.673.64
21414-14140.6890.69
31397-13970.6810.68
41367-13670.6660.67
51263-12630.6160.62
61378-13780.6720.67
10min11972-19720.9610.945.780.970.955.87
22010-20100.9800.99
32052-20521.0001.01
41962-19620.9560.96
51795-17950.8750.88
61789-17890.8720.88
15min12326-23261.1341.148.241.151.168.18
22728-27281.3301.35
32264-22641.1031.12
42329-23291.1351.15
52214-22141.0791.10
62223-22231.0831.10
20min12661-26611.2971.296.281.331.326.41
22943-29431.4341.47
32486-24861.2121.24
42512-25121.2241.25
52573-25731.2541.28
62670-26701.3011.33
30min13275-32751.5961.515.951.641.555.90
23362-33621.6381.69
33069-30691.4961.54
42985-29851.4551.50
52902-29021.4141.46
62969-29691.4471.49
45min13793-37931.8491.834.231.911.904.28
23937-39371.9191.99
33963-39631.9311.99
43639-36391.7731.83
53652-36521.7801.84
63596-35961.7531.81
60min14373-43732.1312.065.792.212.145.63
24585-45852.2352.32
34309-43092.1002.18
43963-39631.9312.01
54017-40171.9582.04
64063-40631.9802.06
极限15572-55722.7162.416.762.822.516.54
25008-50082.4412.55
34660-46602.2712.38
44766-47662.3232.42
54729-47292.3052.40
64947-49472.4112.51
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