厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.843156031521313903187331900316490.72
213.953184631839318420.02
单位质量响应值RSD%判断
2286.782282.580.13数据可信
供试品溶液-24032001批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114176-1417639.17638.8313.6439.1838.8313.65
216142-1614244.60944.61
315606-1560643.12843.13
410669-1066929.48429.48
513709-1370937.88537.89
614007-1400738.70938.71
10min122619-2261962.50967.145.1662.7367.365.17
226231-2623172.49072.74
324782-2478268.48668.73
423396-2339664.65664.82
524699-2469968.25768.47
624040-2404066.43666.65
15min125170-2517069.55869.852.3770.1270.442.41
226413-2641372.99373.64
325292-2529269.89570.52
424644-2464468.10568.63
525113-2511369.40169.99
625027-2502769.16369.75
20min126271-2627172.60172.783.0373.5573.763.06
227407-2740775.74076.80
326397-2639772.94973.96
425087-2508769.32970.23
526896-2689674.32875.30
625952-2595271.71972.69
30min129145-2914580.54381.023.1781.9082.403.18
230404-3040484.02385.50
328900-2890079.86681.28
427933-2793377.19478.48
530316-3031683.77985.17
629213-2921380.73182.10
45min132367-3236789.44890.011.7291.2591.841.71
232708-3270890.39092.33
333283-3328391.97993.84
432716-3271690.41292.13
532756-3275690.52392.38
631599-3159987.32589.14
60min133536-3353692.67893.142.2194.9895.472.19
234424-3442495.13297.58
333658-3365893.01595.38
433967-3396793.86996.09
534274-3427494.71897.07
632358-3235889.42391.72
极限132809-3280990.66993.343.0593.4896.192.99
235048-3504896.85799.83
333943-3394393.80396.69
434774-3477496.09998.84
533614-3361492.89495.78
632474-3247489.74392.54
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.982054595205354520513822052367205230720528390.07
215.102054695205444120545680.01
单位质量响应值RSD%判断
137038.65136064.110.51数据可信
供试品溶液-24032001批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132159-1321595.8075.9411.745.815.9411.73
2148735-1487356.5356.54
3149526-1495266.5706.57
4106193-1061934.6664.67
5139457-1394576.1286.13
6134544-1345445.9125.91
10min1174364-1743647.6627.833.167.697.863.20
2174967-1749677.6887.72
3181890-1818907.9928.03
4172005-1720057.5587.58
5187183-1871838.2258.26
6178292-1782927.8347.87
15min1201188-2011888.8408.942.128.929.022.12
2196860-1968608.6508.73
3208655-2086559.1689.25
4202892-2028928.9158.98
5207510-2075109.1189.20
6204248-2042488.9759.05
20min1218326-2183269.5939.852.699.729.972.66
2215853-2158539.4859.61
3226879-2268799.96910.10
4224494-2244949.8649.98
5232006-23200610.19410.32
6227187-2271879.98310.11
30min1245631-24563110.79311.042.7410.9711.222.71
2240272-24027210.55810.74
3253664-25366411.14611.33
4253026-25302611.11811.29
5258593-25859311.36311.55
6255769-25576911.23911.42
45min1267895-26789511.77112.083.1412.0112.323.10
2260758-26075811.45811.70
3281682-28168212.37712.63
4279153-27915312.26612.50
5281946-28194612.38912.64
6277779-27777912.20612.45
60min1278350-27835012.23112.482.0612.5312.792.05
2275977-27597712.12612.43
3286491-28649112.58812.91
4290211-29021112.75213.05
5289418-28941812.71713.04
6284097-28409712.48312.80
极限1281860-28186012.38512.672.1812.7613.052.16
2279009-27900912.26012.63
3293524-29352412.89713.29
4293483-29348312.89613.27
5290234-29023412.75313.14
6291646-29164612.81513.20
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