厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.309123991202912879127791234912480.04
212.379095691167910620.17
单位质量响应值RSD%判断
7418.547361.520.55数据可信
供试品溶液-FA4444批-氢氯噻嗪-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%
5min122913-2291324.73025.444.5624.7325.444.57
223458-2345825.31825.32
323356-2335625.20825.21
424922-2492226.89926.90
524680-2468026.63726.64
622082-2208223.83323.83
10min176625-7662582.70283.022.6882.8383.152.67
273709-7370979.55579.68
375752-7575281.76081.89
478865-7886585.12085.25
577320-7732083.45283.59
679245-7924585.53085.65
15min186311-8631193.15692.731.5193.6993.271.50
285528-8552892.31192.84
386162-8616292.99593.53
483751-8375190.39390.95
586029-8602992.85293.40
687730-8773094.68895.23
20min189590-8959096.69595.950.9597.7096.960.93
289379-8937996.46797.45
389619-8961996.72797.73
487405-8740594.33795.35
588745-8874595.78396.80
688657-8865795.68896.71
30min189530-8953096.63096.801.1698.1298.281.14
290842-9084298.04799.51
390253-9025397.41198.89
487779-8777994.74196.22
589818-8981896.94198.43
689873-8987397.00198.50
45min188925-8892595.97796.481.6897.9598.461.65
291538-9153898.798100.76
390756-9075697.95499.92
487757-8775794.71796.67
588027-8802795.00896.99
689368-8936896.45698.44
60min189029-8902996.09096.871.8398.5499.331.79
292620-9262099.966102.42
390815-9081598.017100.48
488777-8877795.81898.25
588383-8838395.39397.85
688910-8891095.96198.43
极限191430-9143098.68199.041.68101.61101.981.64
293973-93973101.426104.38
392733-92733100.087103.04
489490-8949096.58799.50
591984-9198499.279102.21
690960-9096098.174101.12
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.812685032687232686112684272684142685360.05
214.842680032681882680960.05
单位质量响应值RSD%判断
18132.0718065.770.26数据可信
供试品溶液-FA4444批-厄贝沙坦-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%
5min12193-21930.8080.877.140.810.877.41
22212-22120.8150.81
32338-23380.8610.86
42490-24900.9170.92
52624-26240.9670.97
62290-22900.8440.84
10min110051-100513.7023.724.563.713.734.60
29444-94443.4793.48
39696-96963.5713.58
410591-105913.9013.91
510428-104283.8413.85
610438-104383.8453.85
15min114119-141195.2015.152.875.225.172.88
213275-132754.8904.91
313814-138145.0885.11
414184-141845.2255.25
514091-140915.1905.21
614433-144335.3165.34
20min116411-164116.0455.882.786.095.922.75
215209-152095.6025.65
315905-159055.8595.91
415831-158315.8315.88
515954-159545.8775.93
616395-163956.0396.09
30min117900-179006.5936.542.236.676.622.23
217127-171276.3096.38
317839-178396.5716.65
417598-175986.4826.56
517735-177356.5336.61
618337-183376.7546.83
45min118150-181506.6866.842.296.806.952.27
218287-182876.7366.84
318455-184556.7986.91
418442-184426.7936.90
518778-187786.9177.03
619324-193247.1187.23
60min119579-195797.2127.210.497.367.350.51
219431-194317.1577.30
319494-194947.1817.32
419628-196287.2307.38
519595-195957.2187.36
619695-196957.2557.40
极限120106-201067.4067.402.097.597.582.08
219757-197577.2777.45
320083-200837.3987.58
419513-195137.1887.37
520616-206167.5947.78
620487-204877.5467.73
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.309100491176913039110191126911420.13
212.379096190918909400.04
单位质量响应值RSD%判断
7409.927351.660.56数据可信
供试品溶液-FA4444批-氢氯噻嗪-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%
5min124295-2429526.25530.6415.1426.2530.6315.15
232439-3243935.05635.06
328269-2826930.54930.55
423212-2321225.08425.08
534027-3402736.77236.77
627848-2784830.09430.09
10min175746-7574681.85683.431.7481.9983.581.75
278350-7835084.67084.85
379276-7927685.67085.82
476259-7625982.41082.54
576900-7690083.10383.29
676667-7666782.85183.00
15min184273-8427391.07092.661.0891.6193.241.10
287111-8711194.13794.74
385647-8564792.55593.14
485488-8548892.38392.92
586106-8610693.05193.65
685857-8585792.78293.35
20min187453-8745394.50795.140.9795.5096.170.97
289551-8955196.77497.84
387370-8737094.41795.46
488429-8842995.56296.56
587439-8743994.49295.56
687967-8796795.06296.09
30min189234-8923496.43297.430.8197.9098.940.82
290730-9073098.04899.60
391276-9127698.638100.15
489980-8998097.23898.72
589791-8979197.03498.57
689950-8995097.20598.71
45min188985-8898596.16397.610.8198.1199.600.82
290842-9084298.169100.21
390019-9001997.28099.29
490470-9047097.76799.73
590898-9089898.230100.25
690731-9073198.049100.04
60min189246-8924696.44596.781.1798.8899.271.15
290992-9099298.331100.87
388687-8868795.84198.34
490581-9058197.887100.34
588332-8833295.45797.97
689504-8950496.72399.20
极限191976-9197699.39598.710.73102.31101.680.71
291363-9136398.732101.76
392294-9229499.738102.71
490699-9069998.015100.96
590923-9092398.257101.25
690786-9078698.109101.07
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.812682792684102682792682702685572683590.05
214.842686412684982685700.04
单位质量响应值RSD%判断
18120.1218097.710.09数据可信
供试品溶液-FA4444批-厄贝沙坦-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%
5min13305-33051.2171.3212.941.221.3212.94
23943-39431.4521.45
33439-34391.2661.27
42970-29701.0931.09
54261-42611.5691.57
63524-35241.2971.30
10min19174-91743.3773.512.823.383.512.87
29652-96523.5533.56
39350-93503.4423.45
49393-93933.4583.46
59921-99213.6523.66
69652-96523.5533.56
15min112259-122594.5134.571.534.544.601.54
212561-125614.6244.65
312237-122374.5054.53
412331-123314.5404.56
512722-127224.6844.71
612450-124504.5834.61
20min113775-137755.0715.121.575.125.161.62
213872-138725.1075.16
313632-136325.0195.06
413794-137945.0785.12
514225-142255.2375.29
614081-140815.1845.23
30min115966-159665.8785.841.215.955.921.17
215915-159155.8595.93
315661-156615.7655.84
416157-161575.9486.02
515661-156615.7655.84
615884-158845.8485.92
45min117445-174456.4226.491.426.526.591.39
217502-175026.4436.55
317323-173236.3776.48
417727-177276.5266.63
517977-179776.6186.72
617824-178246.5626.66
60min117717-177176.5226.702.516.656.842.49
217928-179286.6006.74
317723-177236.5256.66
418558-185586.8326.97
518574-185746.8386.98
618683-186836.8787.01
极限119979-199797.3557.092.177.527.262.12
219109-191097.0357.20
318757-187576.9057.07
419012-190126.9997.17
519351-193517.1247.30
619328-193287.1157.28
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