厄贝沙坦片项目信息
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800
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%
112.167351037323207325977325487319117328960.18
212.167328577352397340480.23
单位质量响应值RSD%判断
60271.0560365.790.12数据可信
长期36月-供试品溶液-20210227批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136060-360604.9826.4634.614.986.4634.60
224667-246673.4083.41
356861-568617.8567.86
462184-621848.5918.59
537320-373205.1565.16
663411-634118.7618.76
10min1182602-18260225.22827.3617.6325.2527.3917.65
2150891-15089120.84620.86
3226388-22638831.27731.32
4231467-23146731.97932.02
5169177-16917723.37323.40
6227614-22761431.44631.49
15min1316098-31609843.67144.296.8843.8244.466.93
2291987-29198740.34040.46
3336610-33661046.50546.70
4350848-35084848.47248.67
5301036-30103641.59041.73
6326791-32679145.14845.35
20min1391000-39100054.01954.775.3254.3955.165.37
2373037-37303751.53751.86
3411389-41138956.83657.26
4412227-41222756.95257.40
5371376-37137651.30851.66
6419717-41971757.98658.41
30min1471786-47178665.18067.252.9665.8267.913.02
2476377-47637765.81466.39
3496176-49617668.55069.26
4501636-50163669.30470.03
5473271-47327165.38565.99
6501309-50130969.25969.98
45min1572756-57275679.13079.482.2480.0980.482.23
2561126-56112677.52378.43
3594339-59433982.11183.17
4569590-56959078.69279.77
5587449-58744981.15982.09
6566672-56667278.28979.35
60min1624954-62495486.34185.401.5687.7086.801.57
2601729-60172983.13284.43
3613662-61366284.78186.25
4627895-62789586.74788.22
5623387-62338786.12587.46
6617254-61725485.27786.73
极限1656799-65679990.74190.623.6592.5392.453.61
2634751-63475187.69589.41
3628023-62802386.76588.65
4695686-69568696.11398.02
5662216-66221691.48993.26
6658274-65827490.94492.83
厄贝沙坦片项目信息
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800
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%
112.167234967237567237767229897238017235640.05
212.167248307247157247720.02
单位质量响应值RSD%判断
59503.6259602.960.12数据可信
长期36月-供试品溶液-20210301批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136125-361255.0558.9955.225.058.9855.25
270685-706859.8919.89
398569-9856913.79313.79
471240-712409.9699.97
59446-94461.3221.32
699244-9924413.88713.89
10min1191073-19107326.73731.4028.4926.7631.4428.52
2198254-19825427.74227.79
3284229-28422939.77239.84
4256571-25657135.90235.95
5126025-12602517.63517.64
6290257-29025740.61640.69
15min1316777-31677744.32749.0413.2344.4949.2413.31
2344122-34412248.15348.34
3384996-38499653.87354.14
4383466-38346653.65953.89
5277868-27786838.88238.98
6395316-39531655.31755.59
20min1410482-41048257.43958.377.2957.8258.827.40
2410730-41073057.47457.90
3439428-43942861.49062.03
4421406-42140658.96859.47
5366101-36610151.22951.52
6454726-45472663.63064.18
30min1483677-48367767.68170.265.0268.3571.005.13
2502088-50208870.25870.97
3513046-51304671.79172.64
4520550-52055072.84173.63
5462593-46259364.73165.28
6530475-53047574.23075.10
45min1545570-54557076.34283.806.0277.3584.896.06
2594198-59419883.14784.21
3621575-62157586.97788.18
4595490-59549083.32784.48
5583776-58377681.68882.56
6652448-65244891.29892.54
60min1612288-61228885.67888.111.5587.0789.621.63
2625751-62575187.56289.05
3635529-63552988.93090.57
4638294-63829489.31790.89
5629780-62978088.12689.40
6636350-63635089.04590.74
极限1650739-65073991.05892.390.9992.8794.341.02
2665021-66502193.05794.98
3666050-66605093.20195.28
4665368-66536893.10595.13
5660271-66027192.39294.11
6654150-65415091.53693.68
厄贝沙坦片项目信息
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800
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%
112.167246267248087239787248277249417246360.06
212.167251627255817253720.05
单位质量响应值RSD%判断
59591.7859652.300.08数据可信
长期36月-供试品溶液-20210302批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168640-686409.5947.4226.099.597.4226.08
239271-392715.4895.49
366666-666669.3189.32
441634-416345.8195.82
541136-411365.7505.75
661375-613758.5788.58
10min1208194-20819429.09930.8313.5129.1530.8713.50
2178852-17885224.99825.03
3243599-24359934.04834.09
4220212-22021230.77930.81
5208868-20886829.19329.22
6263856-26385636.87936.92
15min1328083-32808345.85647.885.5346.0548.075.53
2348590-34859048.72248.87
3345841-34584148.33848.55
4319694-31969444.68344.87
5339105-33910547.39647.57
6374129-37412952.29252.52
20min1407905-40790557.01358.324.8257.4458.754.84
2411591-41159157.52857.92
3407214-40721456.91657.37
4409563-40956357.24457.65
5408976-40897657.16257.57
6458164-45816464.03764.53
30min1467809-46780965.38568.063.6666.0968.783.66
2490735-49073568.59069.27
3475793-47579366.50167.24
4472424-47242466.03066.72
5503344-50334470.35271.05
6511456-51145671.48672.29
45min1566559-56655979.18879.792.1180.2280.862.10
2575891-57589180.49281.52
3574488-57448880.29681.37
4550374-55037476.92577.95
5586550-58655081.98283.03
6571454-57145479.87281.04
60min1608506-60850685.05186.451.1286.4887.911.13
2624204-62420487.24588.67
3617795-61779586.34987.83
4612448-61244885.60187.01
5625997-62599787.49588.95
6622237-62223786.97088.54
极限1642152-64215289.75390.811.8991.6192.701.85
2663132-66313292.68694.55
3647612-64761290.51692.43
4635641-63564188.84390.68
5666110-66611093.10295.00
6643602-64360289.95691.96
厄贝沙坦片项目信息
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800
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%
112.167238007239997233777238937240027238140.04
212.167249967249307249630.01
单位质量响应值RSD%判断
59524.1859618.670.12数据可信
长期36月-供试品溶液-AA366批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112604-11260415.75213.1414.8515.7513.1414.85
289343-8934312.49812.50
396760-9676013.53613.54
482948-8294811.60311.60
575832-7583210.60810.61
6106036-10603614.83314.83
10min1299606-29960641.91139.924.3041.9939.984.31
2275191-27519138.49638.56
3292925-29292540.97741.04
4266349-26634937.25937.32
5288870-28887040.41040.46
6289185-28918540.45440.53
15min1366803-36680351.31150.582.4051.6050.842.41
2358309-35830950.12350.38
3363726-36372650.88151.15
4345436-34543648.32248.57
5367211-36721151.36851.62
6367948-36794851.47251.75
20min1400565-40056556.03458.222.8156.5858.742.79
2420806-42080658.86659.37
3422613-42261359.11959.65
4402055-40205556.24356.73
5426346-42634659.64160.15
6424566-42456659.39259.93
30min1470004-47000465.74867.301.8866.5768.111.85
2489222-48922268.43669.24
3470516-47051665.82066.64
4484582-48458267.78768.55
5481442-48144267.34868.16
6490823-49082368.66069.49
45min1515385-51538572.09673.832.8073.2574.972.74
2529225-52922574.03275.17
3508163-50816371.08672.24
4537427-53742775.18076.29
5549053-54905376.80677.95
6527315-52731573.76574.94
60min1544401-54440176.15578.902.7877.6780.412.73
2571813-57181379.99081.50
3547805-54780576.63178.14
4575942-57594280.56782.05
5583103-58310381.56983.10
6560982-56098278.47580.02
极限1590198-59019882.56283.382.2684.4685.292.22
2598118-59811883.67085.58
3582936-58293681.54683.44
4599497-59949783.86385.75
5619959-61995986.72588.66
6585545-58554581.91183.85
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