培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.022111920930211182107520837210160.61
210.022083121086209580.87
单位质量响应值RSD%判断
2097.412091.620.20数据可信
供试品溶液-2022081901批-培哚普利-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%
5min124214-2421498.63699.291.0998.6499.301.09
224320-2432099.06899.07
324783-24783100.954100.95
424008-2400897.79797.80
524428-2442899.50899.51
624499-2449999.79799.80
10min124980-24980101.756101.120.95102.85102.220.95
224708-24708100.648101.75
325157-25157102.477103.60
424482-2448299.728100.81
524876-24876101.333102.44
624741-24741100.783101.89
15min124806-24806101.048100.581.20103.27102.811.18
225130-25130102.367104.59
324768-24768100.893103.15
424294-2429498.962101.16
524719-24719100.693102.92
624434-2443499.532101.76
20min124630-24630100.33199.371.39103.68102.711.37
224548-2454899.997103.35
324781-24781100.946104.33
423834-2383497.088100.38
524257-2425798.811102.16
624311-2431199.031102.37
30min124038-2403897.91997.650.60102.38102.100.61
224136-2413698.318102.79
324081-2408198.094102.60
423746-2374696.730101.10
523902-2390297.365101.81
623929-2392997.475101.91
45min123510-2351095.76896.200.75101.32101.730.74
223816-2381697.015102.57
323847-2384797.141102.73
423468-2346895.597101.05
523602-2360296.143101.67
623454-2345495.540101.06
极限123958-2395897.59396.091.48104.21102.691.43
223573-2357396.025102.66
324071-2407198.054104.73
423379-2337995.235101.74
523306-2330694.937101.54
623249-2324994.705101.28
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.878156181223812428152481480814060.20
213.908144982074817620.55
单位质量响应值RSD%判断
5869.215882.160.16数据可信
供试品溶液-2022081901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%
5min151594-5159456.92358.626.3456.9258.626.33
248010-4801052.96852.97
356322-5632262.13962.14
456204-5620462.00962.01
551308-5130856.60756.61
655373-5537361.09261.09
10min170529-7052977.81378.982.3778.4579.632.40
269171-6917176.31576.90
373705-7370581.31782.01
473247-7324780.81281.50
571212-7121278.56779.20
671663-7166379.06479.74
15min177433-7743385.43086.541.1386.9388.071.15
277480-7748085.48286.92
378544-7854486.65688.25
478599-7859986.71788.30
578822-7882286.96388.46
679772-7977288.01189.57
20min180603-8060388.92889.230.9791.3791.720.96
280851-8085189.20191.59
382211-8221190.70293.26
479824-7982488.06890.62
581122-8112289.50091.97
680659-8065988.98991.52
30min181540-8154089.96190.950.7093.4094.430.68
283029-8302991.60494.98
382899-8289991.46195.03
482608-8260891.14094.67
582567-8256791.09494.56
681953-8195390.41793.94
45min183137-8313791.72391.900.4896.1696.390.47
283591-8359192.22496.62
383694-8369492.33896.92
483539-8353992.16796.71
583200-8320091.79396.27
682623-8262391.15695.68
极限184688-8468893.43492.330.9998.8997.840.94
283565-8356592.19597.62
384630-8463093.37098.98
483278-8327891.87997.44
583381-8338191.99297.49
682573-8257391.10196.64
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.022094220967209262100220879209430.22
210.022100721148210780.48
单位质量响应值RSD%判断
2090.122103.590.46数据可信
供试品溶液-2022081901批-培哚普利-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%
5min123776-2377696.74498.111.8696.7498.111.86
223943-2394397.42497.42
323942-2394297.42097.42
425004-25004101.741101.74
524096-2409698.04698.05
623916-2391697.31497.31
10min123994-2399497.63199.341.6098.71100.431.60
224674-24674100.398101.48
324031-2403197.78298.86
424996-24996101.708102.84
524279-2427998.79199.88
624504-2450499.707100.79
15min123782-2378296.76998.021.5298.93100.211.53
224343-2434399.051101.25
323702-2370296.44398.61
424678-24678100.415102.68
523982-2398297.58399.77
624045-2404597.839100.03
20min123654-2365496.24897.302.4099.48100.582.37
224261-2426198.718102.02
323389-2338995.17098.41
424874-24874101.212104.59
523412-2341295.26398.53
623887-2388797.196100.47
30min123162-2316294.24696.092.0898.55100.462.06
224163-2416398.319102.71
323300-2330094.80799.11
424282-2428298.803103.30
523226-2322694.50698.84
623560-2356095.865100.22
45min122955-2295593.40494.981.4698.76100.421.45
223704-2370496.451101.94
323095-2309593.97399.32
423575-2357595.926101.53
523068-2306893.86399.24
623663-2366396.285101.71
极限123101-2310193.99894.411.63100.39100.891.62
223417-2341795.284101.84
322786-2278692.71699.11
423831-2383196.968103.63
522916-2291693.24599.67
623159-2315994.234100.72
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.878125781344810628104280992811390.19
213.908131281442813770.12
单位质量响应值RSD%判断
5849.965854.460.06数据可信
供试品溶液-2022081901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%
5min149203-4920354.50258.104.9154.5058.104.91
251712-5171257.28257.28
355153-5515361.09361.09
455545-5554561.52761.53
552840-5284058.53158.53
650231-5023155.64155.64
10min165942-6594273.04477.743.3673.6578.393.36
271130-7113078.79179.43
370562-7056278.16278.84
473123-7312380.99981.68
570207-7020777.76878.42
670139-7013977.69378.31
15min173770-7377081.71584.892.4683.1386.402.48
277066-7706685.36686.88
376061-7606184.25385.80
479585-7958588.15789.74
577058-7705885.35786.87
676297-7629784.51486.00
20min176929-7692985.21487.652.5387.5490.102.53
280305-8030588.95491.41
378658-7865887.13089.61
482399-8239991.27493.84
577433-7743385.77388.24
679037-7903787.55089.97
30min178983-7898387.49089.763.2190.7693.183.18
283084-8308492.03295.48
379227-7922787.76091.21
485353-8535394.54698.12
579467-7946788.02691.44
680065-8006588.68892.08
45min179962-7996288.57490.541.7692.8294.971.78
282919-8291991.85096.32
380895-8089589.60894.03
483493-8349392.48597.11
580626-8062689.31093.70
682551-8255191.44295.82
极限182230-8223091.08691.022.0996.3196.452.07
282884-8288491.81197.30
379895-7989588.50093.92
485003-8500394.15899.81
581250-8125090.00195.39
681769-8176990.57695.97
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