阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632803512806452806642805602805052805450.05
210.692794492796952795720.07
单位质量响应值RSD%判断
26391.8226152.670.65数据可信
供试品溶液-2026050721批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134424-13442445.93551.7620.2345.9451.7620.23
2185336-18533663.33363.33
3186523-18652363.73863.74
4107769-10776936.82736.83
5153831-15383152.56752.57
6140928-14092848.15848.16
10min1224317-22431776.65385.048.5676.9185.338.59
2271855-27185592.89893.25
3270044-27004492.27992.63
4225955-22595577.21377.42
5259290-25929088.60488.90
6241748-24174882.61082.88
15min1245995-24599584.06191.035.7384.7491.805.79
2281984-28198496.35997.23
3279411-27941195.48096.35
4250172-25017285.48886.12
5274926-27492693.94794.73
6265918-26591890.86991.60
20min1247561-24756184.59692.955.1185.7494.225.15
2282016-28201696.37097.77
3281783-28178396.29097.69
4263995-26399590.21291.32
5281908-28190896.33397.64
6274805-27480593.90695.14
30min1254457-25445786.95294.594.4088.5796.374.44
2285259-28525997.47899.42
3282261-28226196.45498.39
4270827-27082792.54694.16
5284664-28466497.27599.12
6283302-28330296.80998.56
45min1260709-26070989.08995.773.7491.1998.083.77
2287106-28710698.109100.59
3282325-28232596.47598.94
4277051-27705194.67396.80
5285360-28536097.51399.89
6289045-28904598.772101.06
60min1286381-28638197.86196.882.00100.4699.722.00
2284332-28433297.161100.19
3281435-28143596.17199.18
4273183-27318393.35196.00
5286884-28688498.033100.96
6288900-28890098.722101.56
极限1291121-29112199.481100.331.14102.62103.701.22
2294661-294661100.691104.26
3292696-292696100.019103.56
4288868-28886898.711101.88
5297426-297426101.636105.10
6296777-296777101.414104.80
阿齐沙坦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100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.517036070497704677023470311703740.16
214.557012970288702080.17
单位质量响应值RSD%判断
4850.034825.290.37数据可信
供试品溶液-2026050721批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152191-5219169.80778.126.6069.8178.126.60
262131-6213183.10183.10
362888-6288884.11484.11
457556-5755676.98276.98
558219-5821977.86977.87
657467-5746776.86376.86
10min163453-6345384.87089.713.1085.2690.143.11
265786-6578687.99088.45
369099-6909992.42192.89
467948-6794890.88291.31
568132-6813291.12891.56
667999-6799990.95091.38
15min168654-6865491.82691.905.8892.6992.835.82
260868-6086881.41282.36
369671-6967193.18694.17
472282-7228296.67997.61
569747-6974793.28894.23
671013-7101394.98195.91
20min165506-6550687.61694.163.7388.9995.603.72
269695-6969593.21894.62
371923-7192396.19897.70
472406-7240696.84498.31
570545-7054594.35595.81
672298-7229896.70098.16
30min169038-6903892.34095.083.6494.2097.053.61
268704-6870491.89393.81
373732-7373298.618100.65
473381-7338198.149100.16
568481-6848191.59593.58
673182-7318297.88299.88
45min170252-7025293.96397.191.9496.3399.681.95
272276-7227696.67199.10
372154-7215496.50799.09
473739-7373998.627101.18
573898-7389898.840101.33
673676-7367698.543101.08
60min172439-7243996.88997.241.1599.78100.271.17
271137-7113795.14798.12
373083-7308397.750100.87
472886-7288697.487100.59
573224-7322497.939100.98
673422-7342298.203101.29
极限174269-7426999.33698.861.26102.77102.431.25
272675-7267597.204100.70
373565-7356598.395102.05
475453-75453100.920104.56
573524-7352498.340101.92
673995-7399598.970102.60
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632799282797032799522798482799532798770.04
210.692801052798192799620.08
单位质量响应值RSD%判断
26328.9726189.150.38数据可信
供试品溶液-2026050721批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1205041-20504170.10055.3628.0770.1055.3628.07
2155709-15570953.23453.23
3218195-21819574.59774.60
492535-9253531.63631.64
5159020-15902054.36654.37
6141007-14100748.20848.21
10min1281287-28128796.16886.9710.3796.5687.2810.42
2248039-24803984.80185.10
3279393-27939395.52095.93
4210273-21027371.88972.06
5245330-24533083.87584.18
6261959-26195989.56089.83
15min1285933-28593397.75692.136.6398.6892.926.71
2267855-26785591.57592.34
3282517-28251796.58897.53
4237122-23712281.06881.64
5264973-26497390.59091.36
6278535-27853595.22795.99
20min1282883-28288396.71393.525.0298.1894.835.12
2273204-27320493.40494.68
3286145-28614597.82999.31
4249485-24948585.29586.32
5267286-26728691.38192.65
6282322-28232296.52197.82
30min1283711-28371196.99694.503.4799.0096.323.60
2275635-27563594.23596.03
3285392-28539297.57199.60
4259466-25946688.70790.21
5272842-27284293.28095.06
6281394-28139496.20498.03
45min1283185-28318596.81794.963.1699.3697.303.29
2276537-27653794.54496.86
3286185-28618597.842100.41
4263107-26310789.95291.94
5272995-27299593.33395.63
6284488-28448897.26299.63
60min1281747-28174796.32594.692.9499.4197.563.08
2276719-27671994.60697.45
3285246-28524697.521100.63
4261769-26176989.49591.99
5276382-27638294.49197.31
6279868-27986895.68398.59
极限1287745-28774598.37698.591.06101.99101.990.97
2282880-28288096.712100.08
3287905-28790598.430102.08
4291346-29134699.607102.60
5290025-29002599.155102.50
6290362-29036299.270102.71
阿齐沙坦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100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.517045970354704047040470499704240.08
214.556985469697697760.16
单位质量响应值RSD%判断
4853.484795.600.85数据可信
供试品溶液-2026050721批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159855-5985580.27777.474.6380.2877.474.63
255954-5595475.04575.05
360829-6082981.58481.58
455190-5519074.02174.02
554949-5494973.69773.70
659794-5979480.19680.20
10min167401-6740190.39890.460.8290.8490.880.80
268040-6804091.25591.67
367558-6755890.60991.06
467449-6744990.46290.87
567785-6778590.91391.32
666437-6643789.10589.55
15min170197-7019794.14893.282.3195.1094.212.28
269753-6975393.55394.48
367838-6783890.98491.94
472272-7227296.93197.84
568211-6821191.48492.40
669022-6902292.57293.51
20min170751-7075194.89194.551.6096.3696.001.58
269097-6909792.67394.12
369750-6975093.54995.01
472057-7205796.64398.09
569883-6988393.72795.15
671446-7144695.82397.28
30min167733-6773390.84394.803.7592.8496.773.66
271660-7166096.11098.07
367053-6705389.93191.91
471849-7184996.36498.35
573621-7362198.740100.68
672167-7216796.79098.78
45min170037-7003793.93395.402.2996.4497.902.24
272020-7202096.59399.09
369110-6911092.69095.17
473172-7317298.138100.66
572448-7244897.16799.66
670004-7000493.88996.41
60min166866-6686689.68194.684.5792.7197.724.44
272524-7252497.269100.30
366552-6655289.25992.26
472788-7278897.623100.69
574233-7423399.561102.59
670618-7061894.71397.76
极限170197-7019794.14895.322.6797.6798.882.61
273339-7333998.362101.93
368394-6839491.73095.22
472663-7266397.455101.07
571999-7199996.565100.15
669839-6983993.66897.24
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632792732788012789342791842795182791420.11
210.692792062792962792510.03
单位质量响应值RSD%判断
26259.8326122.640.38数据可信
供试品溶液-2026050821批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204206-20420669.99656.7824.1070.0056.7824.10
2136115-13611546.65646.66
3176425-17642560.47360.47
4129871-12987144.51644.52
5128443-12844344.02644.03
6218825-21882575.00775.01
10min1268446-26844692.01587.126.0892.4087.436.12
2242314-24231483.05883.32
3251118-25111886.07686.41
4232217-23221779.59779.84
5258274-25827488.52988.77
6272556-27255693.42493.84
15min1274128-27412893.96391.524.1294.8692.324.18
2258540-25854088.62089.34
3266271-26627191.27092.08
4250174-25017485.75286.44
5273310-27331093.68294.42
6279604-27960495.84096.78
20min1273655-27365593.80192.563.4395.2293.863.48
2265536-26553691.01892.23
3267166-26716691.57692.90
4255417-25541787.54988.72
5277524-27752495.12796.38
6280866-28086696.27297.74
30min1274058-27405893.93993.392.9195.8895.212.95
2270562-27056292.74094.46
3268764-26876492.12493.95
4259925-25992589.09490.75
5281436-28143696.46898.25
6279928-27992895.95197.95
45min1272467-27246793.39393.002.4995.8695.342.53
2269966-26996692.53694.77
3271413-27141393.03295.37
4259337-25933788.89391.04
5279202-27920295.70298.02
6275529-27552994.44396.98
60min1276422-27642294.74993.302.6797.7396.162.74
2269029-26902992.21594.96
3267478-26747891.68394.54
4262149-26214989.85792.50
5276105-27610594.64097.49
6282050-28205096.67899.74
极限1280999-28099996.31899.013.6899.83102.393.65
2286654-28665498.256101.52
3286064-28606498.054101.42
4284297-28429797.448100.59
5284972-28497297.680101.06
6310151-310151106.310109.91
阿齐沙坦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100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516930969061695516898368995691800.36
214.556881069474691420.68
单位质量响应值RSD%判断
4767.754752.030.24数据可信
供试品溶液-2026050821批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155356-5535675.24974.367.3175.2574.367.31
251120-5112069.49169.49
352729-5272971.67871.68
450465-5046568.60168.60
560523-6052382.27382.27
658000-5800078.84378.84
10min166198-6619889.98887.515.8190.4187.925.80
266794-6679490.79891.18
361629-6162983.77784.17
458445-5844579.44879.83
568598-6859893.25093.71
664569-6456987.77388.21
15min170453-7045395.77292.365.0096.6993.274.98
269933-6993395.06595.96
367998-6799892.43493.30
463039-6303985.69386.52
571529-7152997.23498.21
664730-6473087.99288.92
20min170954-7095496.45392.682.5797.9094.092.59
267943-6794392.36093.78
367058-6705891.15792.53
465771-6577189.40790.71
568801-6880193.52695.04
668546-6854693.17994.59
30min170117-7011795.31593.761.8997.3095.691.93
268198-6819892.70694.64
368450-6845093.04994.93
467458-6745891.70093.50
570950-7095096.44798.48
668676-6867693.35695.29
45min161639-6163983.79091.666.2986.3194.116.16
272358-7235898.361100.81
364710-6471087.96590.37
465158-6515888.57490.88
571452-7145297.13099.70
669270-6927094.16496.61
60min170129-7012995.33192.275.7798.3195.235.69
269865-6986594.97297.97
361876-6187684.11287.00
464595-6459587.80990.61
572401-7240198.420101.53
668406-6840692.98995.96
极限170710-7071096.12196.192.4499.6399.662.42
272810-7281098.976102.50
368801-6880193.52696.88
469401-6940194.34297.63
569973-6997395.11998.78
672853-7285399.034102.52
阿齐沙坦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68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632797732795232794822799812797772797070.08
210.692794152793862794000.01
单位质量响应值RSD%判断
26312.9826136.580.48数据可信
供试品溶液-2026050821批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151586-15158651.89360.0818.0051.8960.0818.00
2223927-22392776.65876.66
3144286-14428649.39449.39
4199569-19956968.31968.32
5180314-18031461.72761.73
6153333-15333352.49152.49
10min1278992-27899295.50890.993.9595.8091.323.97
2275855-27585594.43494.86
3250684-25068485.81786.09
4265231-26523190.79791.18
5264869-26486990.67391.02
6259128-25912888.70889.00
15min1287244-28724498.33393.912.7699.1594.742.77
2278812-27881295.44696.40
3268169-26816991.80392.55
4273895-27389593.76394.65
5269754-26975492.34693.19
6267990-26799091.74292.53
20min1288017-28801798.59894.772.3499.9696.132.35
2281115-28111596.23597.72
3273259-27325993.54694.81
4274559-27455993.99195.40
5271084-27108492.80194.16
6272924-27292493.43194.72
30min1284522-28452297.40194.462.3699.3196.342.36
2279835-27983595.79797.81
3276943-27694394.80796.59
4276454-27645494.63996.57
5272177-27217793.17595.05
6265572-26557290.91492.73
45min1290551-29055199.46595.252.29101.9297.672.26
2279065-27906595.53398.08
3275836-27583694.42896.74
4273318-27331893.56696.02
5274099-27409993.83396.23
6276625-27662594.69897.02
60min1286761-28676198.16894.612.34101.1797.552.33
2278593-27859395.37298.45
3273480-27348093.62196.45
4278004-27800495.17098.14
5267630-26763091.61994.53
6273697-27369793.69596.54
极限1290061-29006199.29797.520.99102.85100.990.98
2283233-28323396.960100.57
3284009-28400997.226100.58
4281843-28184396.48499.99
5284848-28484897.513100.94
6285279-28527997.660101.03
阿齐沙坦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100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516938169705695596974469703696180.22
214.556962469652696380.03
单位质量响应值RSD%判断
4797.934786.120.18数据可信
供试品溶液-2026050821批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161039-6103982.41878.313.5482.4278.313.54
256487-5648776.27276.27
357184-5718477.21377.21
455364-5536474.75574.76
558852-5885279.46579.47
659046-5904679.72779.73
10min166638-6663889.97888.732.9190.4489.172.91
262965-6296585.01985.44
366702-6670290.06490.49
463665-6366585.96486.38
566697-6669790.05890.50
667636-6763691.32691.77
15min172084-7208497.33292.403.4098.2993.333.39
265648-6564888.64189.54
369135-6913593.35094.28
466219-6621989.41290.31
568340-6834092.27693.22
669147-6914793.36694.32
20min174901-74901101.13593.415.83102.6394.855.78
265625-6562588.61090.00
371183-7118396.11597.56
465625-6562588.61090.00
565780-6578088.82090.27
671958-7195897.16198.63
30min173860-7386099.73091.415.03101.7993.374.99
265881-6588188.95690.84
367179-6717990.70992.69
463799-6379986.14588.03
566988-6698890.45192.40
668490-6849092.47994.49
45min173830-7383099.68994.494.48102.3096.964.46
267091-6709190.59092.96
372546-7254697.955100.44
465633-6563388.62190.98
570287-7028794.90597.36
670479-7047995.16497.69
60min173729-7372999.55394.484.22102.7297.474.20
266485-6648589.77192.65
370648-7064895.39398.42
467943-6794391.74094.59
568067-6806791.90894.89
672960-7296098.514101.57
极限173715-7371599.53494.704.74103.2698.224.70
265718-6571888.73692.11
371556-7155696.619100.18
467531-6753191.18494.55
568695-6869592.75696.24
673583-7358399.356102.95
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