比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078530085408854238542285489854080.08
210.088531885407853620.08
单位质量响应值RSD%判断
8481.438468.450.11数据可信
加速3月-供试品溶液-2023101321批-比索洛尔-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%
5min192229-9222997.74798.571.8297.7598.571.81
293528-9352899.12499.12
393593-9359399.19399.19
493114-9311498.68598.69
590248-9024895.64895.65
695315-95315101.018101.02
10min192940-9294098.50199.471.7598.6699.641.75
294402-94402100.050100.22
394113-9411399.74499.91
494086-9408699.71599.88
591326-9132696.79096.95
696258-96258102.017102.19
15min192608-9260898.14999.161.8298.4899.491.82
294089-9408999.718100.05
394258-9425899.898100.23
493655-9365599.25899.59
590857-9085796.29396.61
695905-95905101.643101.98
20min192503-9250398.03899.151.8098.5399.641.80
294081-9408199.710100.21
394188-9418899.823100.32
493668-9366899.27299.77
590957-9095796.39996.88
695916-95916101.655102.16
30min192220-9222097.73898.901.9098.3999.561.90
294159-9415999.793100.46
393951-9395199.572100.24
493526-9352699.12299.78
590466-9046695.87996.52
695572-95572101.290101.97
45min192218-9221897.73598.801.7198.5599.621.71
294073-9407399.701100.53
393818-9381899.431100.26
493350-9335098.93599.76
590657-9065796.08196.88
695198-95198100.894101.74
极限191789-9178997.28198.561.8298.2699.551.83
293976-9397699.599100.60
393395-9339598.98399.98
493096-9309698.66699.66
590438-9043895.84996.81
695274-95274100.974101.99
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715449054517546075466254487545530.15
214.695444554414544300.05
单位质量响应值RSD%判断
3708.573705.240.07数据可信
加速3月-供试品溶液-2023101321批-左氨氯地平-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%
5min153899-5389991.80490.740.9191.8090.740.91
253642-5364291.36691.37
353008-5300890.28690.29
453420-5342090.98890.99
553142-5314290.51490.51
652546-5254689.49989.50
10min154761-5476193.27293.070.9493.4293.220.94
255322-5532294.22794.38
354264-5426492.42592.58
455135-5513593.90994.06
554036-5403692.03792.19
654347-5434792.56792.72
15min154456-5445692.75293.450.9093.0693.760.89
255168-5516893.96594.27
354998-5499893.67693.98
455638-5563894.76695.07
554386-5438692.63392.94
654559-5455992.92893.23
20min154957-5495793.60692.920.9694.0793.380.95
254021-5402192.01192.48
354386-5438692.63393.09
455346-5534694.26894.73
554057-5405792.07392.53
654549-5454992.91193.37
30min155024-5502493.72092.830.8294.3493.450.82
254035-5403592.03592.65
354215-5421592.34292.96
455090-5509093.83294.46
554433-5443392.71393.33
654230-5423092.36792.98
45min154761-5476193.27292.731.1094.0593.501.09
254230-5423092.36793.14
354218-5421892.34793.12
455508-5550894.54495.32
553993-5399391.96492.73
653955-5395591.89992.67
极限154798-5479893.33592.860.9894.2793.780.98
254729-5472993.21794.14
353848-5384891.71792.64
455286-5528694.16695.10
554020-5402092.01092.93
654432-5443292.71293.63
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078562485617856168562785586856140.02
210.088555785553855550.01
单位质量响应值RSD%判断
8501.898487.600.12数据可信
加速3月-供试品溶液-2023101322批-比索洛尔-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%
5min190256-9025695.43396.971.5295.4396.971.52
293210-9321098.55798.56
391832-9183297.10097.10
492040-9204097.31997.32
593057-9305798.39598.39
689880-8988095.03695.04
10min190854-9085496.06597.531.4196.2297.701.41
293318-9331898.67198.84
392661-9266197.97698.14
492615-9261597.92798.09
593561-9356198.92899.09
690454-9045495.64295.80
15min190585-9058595.78197.391.4296.1097.721.42
293067-9306798.40598.73
392509-9250997.81598.14
492750-9275098.07098.40
593381-9338198.73799.07
690372-9037295.55695.87
20min190363-9036395.54697.171.4796.0397.661.47
293158-9315898.50298.99
392238-9223897.52998.02
492486-9248697.79198.28
593068-9306898.40698.90
690077-9007795.24495.72
30min189951-8995195.11196.991.5795.7597.641.56
292967-9296798.30098.96
392249-9224997.54098.19
492256-9225697.54898.20
593025-9302598.36199.02
689906-8990695.06395.70
45min190050-9005095.21596.751.4096.0197.561.40
292889-9288998.21799.04
391711-9171196.97297.78
492106-9210697.38998.20
592438-9243897.74098.56
689818-8981894.97095.76
极限190079-9007995.24696.731.3696.2097.701.37
292959-9295998.29199.28
391568-9156896.82097.80
491858-9185897.12798.10
592495-9249597.80198.78
689932-8993295.09196.04
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715467654589546615455754522546010.13
214.695458754611545990.04
单位质量响应值RSD%判断
3711.833716.750.10数据可信
加速3月-供试品溶液-2023101322批-左氨氯地平-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%
5min153058-5305890.19290.591.5790.1990.591.57
254529-5452992.69292.69
353886-5388691.59991.60
453151-5315190.35090.35
552081-5208188.53188.53
653040-5304090.16190.16
10min152825-5282589.79691.301.9389.9591.451.93
255381-5538194.14094.29
353611-5361191.13291.28
454297-5429792.29892.45
552515-5251589.26989.42
653615-5361591.13891.29
15min153029-5302990.14291.031.5190.4491.331.51
254818-5481893.18393.49
354104-5410491.97092.27
453413-5341390.79591.10
552542-5254289.31489.61
653404-5340490.78091.08
20min153171-5317190.38491.381.0690.8391.831.06
254561-5456192.74793.21
354299-5429992.30192.76
453762-5376291.38891.84
553293-5329390.59191.04
653450-5345090.85891.31
30min152852-5285289.84190.741.5890.4491.351.58
254413-5441392.49593.12
354186-5418692.10992.72
453750-5375091.36891.98
552516-5251689.27089.87
652568-5256889.35989.96
45min153368-5336890.71991.060.9791.4791.810.98
254422-5442292.51093.29
353751-5375191.37092.13
453630-5363091.16491.92
552874-5287489.87990.62
653351-5335190.69091.44
极限153736-5373691.34491.171.6392.2592.081.62
254906-5490693.33394.26
353717-5371791.31292.23
453381-5338190.74191.65
552208-5220888.74789.64
653867-5386791.56792.47
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078680286798867508680386774867850.03
210.088539385331853620.06
单位质量响应值RSD%判断
8618.178468.451.24数据可信
加速3月-供试品溶液-2023101323批-比索洛尔-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%
5min191022-9102295.70396.232.1895.7096.232.18
292632-9263297.39697.40
388378-8837892.92392.92
494177-9417799.02099.02
590631-9063195.29295.29
692288-9228897.03497.03
10min191761-9176196.48097.012.0196.6497.172.01
292700-9270097.46897.63
389445-8944594.04594.20
494875-9487599.75499.92
591450-9145096.15396.31
693360-9336098.16198.32
15min191898-9189896.62496.872.0596.9497.192.05
292542-9254297.30197.63
389624-8962494.23394.54
495148-95148100.041100.37
590808-9080895.47895.80
692752-9275297.52297.85
20min191529-9152996.23696.672.0596.7297.152.05
292603-9260397.36697.85
389277-8927793.86894.34
494820-9482099.697100.19
590816-9081695.48795.96
692612-9261297.37597.86
30min191306-9130696.00296.512.1196.6497.162.11
292658-9265897.42398.07
389053-8905393.63394.26
494668-9466899.537100.20
590617-9061795.27795.91
692462-9246297.21797.87
45min191167-9116795.85696.472.1896.6697.282.18
292532-9253297.29198.10
388874-8887493.44594.23
494773-9477399.647100.48
590740-9074095.40796.20
692435-9243597.18998.00
极限190834-9083495.50696.032.2396.4796.992.23
292363-9236397.11398.09
388293-8829392.83493.77
494317-9431799.168100.16
590332-9033294.97895.93
691838-9183896.56197.54
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715455554468546585448854509545360.14
214.695453154491545110.06
单位质量响应值RSD%判断
3707.413710.760.07数据可信
加速3月-供试品溶液-2023101323批-左氨氯地平-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%
5min153565-5356591.18187.494.1691.1887.494.16
252810-5281089.89689.90
350931-5093186.69786.70
452458-5245889.29789.30
551036-5103686.87686.88
647574-4757480.98380.98
10min153128-5312890.43790.781.7090.5990.931.71
254600-5460092.94393.09
352523-5252389.40789.55
453680-5368091.37791.53
553893-5389391.74091.88
652162-5216288.79388.93
15min153716-5371691.43890.931.1291.7491.221.13
253899-5389991.75092.05
352566-5256689.48189.77
453917-5391791.78092.08
553650-5365091.32691.62
652754-5275489.80190.08
20min153506-5350691.08190.881.3691.5491.341.36
253928-5392891.79992.26
352626-5262689.58390.03
454320-5432092.46692.92
553498-5349891.06791.52
652463-5246389.30589.74
30min152793-5279389.86790.731.5990.4791.331.58
254264-5426492.37192.98
352759-5275989.80990.40
454272-5427292.38592.99
553465-5346591.01191.61
652253-5225388.94889.53
45min153743-5374391.48490.742.4492.2491.492.44
254674-5467493.06993.83
351526-5152687.71088.45
454151-5415192.17992.94
553898-5389891.74892.50
651839-5183988.24388.97
极限153865-5386591.69290.212.3592.6091.122.35
253690-5369091.39492.31
351659-5165987.93788.82
454322-5432292.47093.39
553159-5315990.49091.40
651280-5128087.29288.17
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078546385409854508544985483854510.04
210.088538285397853900.02
单位质量响应值RSD%判断
8485.708471.230.13数据可信
加速3月-供试品溶液-2024010421批-比索洛尔-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%
5min192874-9287498.39097.590.8798.3997.590.87
292440-9244097.93097.93
392131-9213197.60397.60
492557-9255798.05498.05
590604-9060495.98595.99
692131-9213197.60397.60
10min193215-9321598.75198.280.8598.9298.440.85
292886-9288698.40398.57
392865-9286598.38098.54
493218-9321898.75498.92
591202-9120296.61996.78
693210-9321098.74698.91
15min193310-9331098.85298.060.8599.1898.390.85
292717-9271798.22498.55
392718-9271898.22598.55
493093-9309398.62298.95
591097-9109796.50796.83
692464-9246497.95598.28
20min193056-9305698.58398.040.9999.0898.530.99
292477-9247797.96998.46
392454-9245497.94598.44
492952-9295298.47298.96
590863-9086396.25996.74
693479-9347999.03199.52
30min192923-9292398.44297.610.7899.1098.270.78
292192-9219297.66798.32
392179-9217997.65498.31
492546-9254698.04298.70
590814-9081496.20896.85
692193-9219397.66898.32
45min192532-9253298.02897.350.8298.8598.170.82
292191-9219197.66698.48
391734-9173497.18298.00
492331-9233197.81598.63
590474-9047495.84796.65
692119-9211997.59098.41
极限192625-9262598.12697.650.5999.1198.620.57
291790-9179097.24198.22
391929-9192997.38998.37
491907-9190797.36598.35
593043-9304398.56999.53
691736-9173697.18498.17
比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715441954419543965453154420544370.10
214.695436254481544220.16
单位质量响应值RSD%判断
3700.683704.700.08数据可信
加速3月-供试品溶液-2024010421批-左氨氯地平-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%
5min153746-5374691.64791.222.3091.6591.222.30
253820-5382091.77391.77
354556-5455693.02993.03
452475-5247589.48089.48
551600-5160087.98887.99
654772-5477293.39793.40
10min153707-5370791.58193.362.1591.7393.512.15
254472-5447292.88593.04
356285-5628595.97796.13
453577-5357791.35991.51
554356-5435692.68792.83
656104-5610495.66895.82
15min154498-5449892.93093.321.6293.2393.631.62
254575-5457593.06193.37
355615-5561594.83495.15
453225-5322590.75991.06
554845-5484593.52193.82
655607-5560794.82195.14
20min154105-5410592.25992.292.6492.7292.762.63
254077-5407792.21292.67
356308-5630896.01696.49
453319-5331990.91991.37
552082-5208288.81089.27
654862-5486293.55094.02
30min154448-5444892.84493.111.2993.4693.731.29
254134-5413492.30992.93
355321-5532194.33394.97
453781-5378191.70792.31
554360-5436092.69493.30
655578-5557894.77195.40
45min154392-5439292.74992.941.9493.5293.711.93
253734-5373491.62792.40
355308-5530894.31195.10
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253736-5373691.63092.55
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453308-5330890.90091.81
554911-5491193.63494.55
655573-5557394.76395.71
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