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)0
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(%)99.70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%
1102912702920162913332921402918012917120.14
2102906362901492903920.12
单位质量响应值RSD%判断
29171.2029039.200.33数据可信
供试品溶液-6031801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%
5min1195893-19589360.39359.3517.0660.3959.3517.06
2212129-21212965.39965.40
3181162-18116255.85255.85
4214309-21430966.07166.07
5219582-21958267.69667.70
6132049-13204940.71040.71
10min1303413-30341393.54194.542.0393.8894.872.07
2303467-30346793.55893.92
3303443-30344393.55193.86
4312725-31272596.41296.78
5316151-31615197.46897.84
6300690-30069092.70292.93
15min1305131-30513194.07194.811.5594.9395.671.57
2309936-30993695.55296.44
3300714-30071492.70993.54
4308164-30816495.00695.91
5314810-31481097.05597.97
6306470-30647094.48495.22
20min1309942-30994295.55495.241.3196.9396.621.34
2305943-30594394.32195.74
3307203-30720394.71096.05
4310897-31089795.84997.28
5315336-31533697.21798.67
6304122-30412293.76095.03
30min1309938-30993895.55395.042.4097.4696.952.35
2296105-29610591.28893.23
3307766-30776694.88396.75
4306067-30606794.36096.32
5318649-31864998.239100.24
6311143-31114395.92497.71
45min1300210-30021092.55495.271.6494.9997.711.64
2308437-30843795.09097.54
3309007-30900795.26697.66
4311599-31159996.06598.55
5315618-31561897.30499.85
6309340-30934095.36997.69
60min1302242-30224293.18094.821.3396.1397.781.33
2304596-30459693.90696.88
3305628-30562894.22497.15
4310337-31033795.67698.70
5313174-31317496.55199.63
6309322-30932295.36398.21
极限1301432-30143292.93194.101.6296.4097.591.64
2303121-30312193.45196.95
3305929-30592994.31797.77
4307437-30743794.78298.33
5313499-31349996.651100.27
6299875-29987592.45195.83
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)0
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(%) 99.90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%
1157491075029751207506175001750240.11
2157500574636748200.35
单位质量响应值RSD%判断
5001.604988.000.20数据可信
供试品溶液-6031801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%
5min158510-5851075.94877.254.6975.9577.254.69
260273-6027378.23678.24
362161-6216180.68780.69
461730-6173080.12880.13
559895-5989577.74677.75
654496-5449670.73870.74
10min167522-6752287.64690.002.8488.0790.432.83
267009-6700986.98087.41
370591-7059191.63092.08
470434-7043491.42691.87
571992-7199293.44893.88
668483-6848388.89389.29
15min170127-7012791.02791.211.8991.9492.141.87
271072-7107292.25493.17
369863-6986390.68591.64
468203-6820388.53089.48
572184-7218493.69794.65
670171-7017191.08491.97
20min172012-7201293.47492.751.5794.8994.191.56
269929-6992990.77092.20
372823-7282394.52795.99
470812-7081291.91693.36
572374-7237493.94495.42
670778-7077891.87293.27
30min171860-7186093.27792.082.6395.2194.032.58
267874-6787488.10390.04
373129-7312994.92496.91
469904-6990490.73892.69
570811-7081191.91593.91
672057-7205793.53295.44
45min170912-7091292.04693.082.3494.5095.542.30
270457-7045791.45693.88
372546-7254694.16796.68
469589-6958990.32992.79
574103-7410396.18898.69
672639-7263994.28896.71
60min168155-6815588.46892.923.6191.4395.903.54
271151-7115192.35695.29
374220-7422096.34099.38
470754-7075491.84194.80
575022-7502297.381100.42
670196-7019691.11794.06
极限168019-6801988.29192.194.1091.7595.684.01
267199-6719987.22790.67
372509-7250994.11997.69
471623-7162392.96996.44
574964-7496497.306100.89
671817-7181793.22196.67
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)0
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(%)99.70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%
1102912852906632908822910762908922909600.09
2102897722895822896770.05
单位质量响应值RSD%判断
29096.0028967.700.32数据可信
供试品溶液-6032501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%
5min1202267-20226762.51653.8819.7962.5253.8819.80
2162773-16277350.30950.31
3119784-11978437.02237.02
4211271-21127165.29965.30
5193570-19357059.82859.83
6156287-15628748.30548.30
10min1312999-31299996.74096.032.0697.0996.332.10
2314860-31486097.31697.60
3298141-29814192.14892.35
4314659-31465997.25397.62
5310198-31019895.87596.21
6313338-31333896.84597.11
15min1296597-29659791.67195.942.3992.5696.772.36
2316022-31602297.67598.49
3308111-30811195.23095.95
4314024-31402497.05797.96
5311680-31168096.33397.20
6316008-31600897.67098.48
20min1312329-31232996.53395.641.9497.9397.001.91
2299612-29961292.60393.97
3308384-30838495.31496.56
4309393-30939395.62697.07
5308901-30890195.47496.87
6317937-31793798.26799.62
30min1297158-29715891.84495.492.3493.7797.382.31
2309652-30965295.70697.58
3305003-30500394.26996.05
4312211-31221196.49798.47
5311219-31121996.19098.12
6318456-31845698.427100.32
45min1302809-30280993.59194.911.3296.0397.341.31
2308974-30897495.49697.91
3304489-30448994.11096.41
4309546-30954695.67398.18
5303592-30359293.83396.30
6313013-31301396.74599.19
60min1298976-29897692.40694.061.9495.3797.011.92
2308433-30843395.32998.27
3298386-29838692.22495.05
4306480-30648094.72697.77
5300660-30066092.92795.91
6312976-31297696.73399.71
极限1299899-29989992.69294.662.0196.1798.141.98
2303874-30387493.92097.39
3300341-30034192.82896.16
4308448-30844895.33498.90
5315934-31593497.648101.15
6309113-30911395.53999.06
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)0
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(%) 99.90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%
1157485174906749137483675154749320.18
2157491274792748520.12
单位质量响应值RSD%判断
4995.474990.130.08数据可信
供试品溶液-6032501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%
5min160253-6025378.24279.735.8578.2479.735.85
261923-6192380.41080.41
357995-5799575.31075.31
467461-6746187.60287.60
557887-5788775.16975.17
662859-6285981.62681.63
10min170745-7074591.86692.121.9692.3092.561.97
272944-7294494.72295.17
370086-7008691.01091.43
471749-7174993.17093.66
568909-6890989.48289.90
671191-7119192.44592.90
15min167827-6782788.07793.363.4489.0294.323.43
273327-7332795.21996.19
371082-7108292.30493.23
475068-7506897.48098.48
571257-7125792.53193.45
672812-7281294.55095.52
20min168157-6815788.50592.622.4989.9494.102.48
271228-7122892.49394.00
372080-7208093.60095.04
473491-7349195.43296.98
571101-7110192.32893.76
671906-7190693.37494.87
30min168559-6855989.02793.022.2790.9595.002.24
271269-7126992.54794.56
373010-7301094.80796.76
472077-7207793.59695.67
572739-7273994.45596.40
672141-7214193.67995.69
45min170622-7062291.70693.821.6094.1396.331.61
272403-7240394.01996.55
372766-7276694.49096.97
473930-7393096.00298.60
571348-7134892.64995.12
672444-7244494.07296.60
60min167106-6710687.14193.463.6090.0796.493.55
272876-7287694.63397.69
372594-7259494.26797.28
474746-7474697.062100.19
571629-7162993.01496.00
672875-7287594.63297.69
极限166736-6673686.66093.414.1190.0796.954.03
270806-7080691.94595.52
373186-7318695.03698.57
475076-7507697.490101.16
573921-7392195.99099.49
671876-7187693.33596.91
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)0
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(%)99.70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%
1102910762903792907362904802908872907120.10
2102902602902342902470.01
单位质量响应值RSD%判断
29071.2029024.700.12数据可信
供试品溶液-6032601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%
5min1202944-20294462.69055.8011.7462.6955.8011.75
2170624-17062452.70652.71
3204814-20481463.26863.27
4188838-18883858.33358.33
5158382-15838248.92548.92
6158213-15821348.87348.87
10min1314445-31444597.13397.811.8497.4898.121.85
2312133-31213396.41996.71
3323467-32346799.920100.27
4321408-32140899.28499.61
5308619-30861995.33395.61
6319775-31977598.78099.05
15min1313424-31342496.81898.281.9297.7199.141.92
2314974-31497497.29698.12
3323085-32308599.802100.71
4323888-323888100.050100.93
5310016-31001695.76596.57
6323657-32365799.979100.80
20min1313758-31375896.92198.141.8798.3599.541.87
2315259-31525997.38598.75
3322060-32206099.485100.95
4320509-32050999.006100.44
5309291-30929195.54196.87
6325273-325273100.478101.85
30min1312962-31296296.67597.641.9498.6499.581.95
2312213-31221396.44498.35
3321058-32105899.176101.19
4320038-32003898.861100.84
5307333-30733394.93696.80
6322856-32285699.731101.67
45min1304355-30435594.01698.742.7096.52101.232.65
2315332-31533297.40799.85
3325073-325073100.416102.98
4327388-327388101.131103.66
5320879-32087999.121101.51
6324923-324923100.370102.86
60min1312727-31272796.60298.151.9299.63101.181.92
2312066-31206696.39899.39
3325782-325782100.635103.76
4321434-32143499.292102.38
5312213-31221396.44499.39
6322151-32215199.513102.56
极限1299650-29965092.56397.443.7796.12101.023.70
2309420-30942095.58199.10
3329726-329726101.853105.54
4326737-326737100.930104.57
5307170-30717094.88698.36
6319973-31997398.841102.44
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)0
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(%) 99.90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%
1157490474532747957464275101747950.30
2157503674798749170.23
单位质量响应值RSD%判断
4986.334994.470.12数据可信
供试品溶液-6032601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%
5min164655-6465583.99883.237.8584.0083.227.84
266367-6636786.22286.22
368628-6862889.16089.16
466990-6699087.03287.03
554563-5456370.88770.89
663158-6315882.05382.05
10min172524-7252494.22294.301.1694.6994.761.20
272975-7297594.80795.29
373710-7371095.76296.26
472923-7292394.74095.22
571251-7125192.56892.96
672114-7211493.68994.14
15min173463-7346395.44194.473.0096.4395.462.98
274100-7410096.26997.27
375141-7514197.62198.65
469275-6927590.00191.01
570959-7095992.18893.10
673364-7336495.31396.29
20min173847-7384795.94094.714.0697.4696.224.03
276396-7639699.252100.79
374207-7420796.40897.98
468514-6851489.01290.52
570128-7012891.10992.53
674316-7431696.55098.06
30min175566-7556698.17497.431.94100.2399.471.96
277176-77176100.265102.36
375766-7576698.433100.54
474180-7418096.37398.38
573116-7311694.99196.92
674172-7417296.36398.40
45min171394-7139492.75397.413.1695.3599.993.05
275725-7572598.380101.03
376471-7647199.349102.00
476065-7606598.822101.36
577462-77462100.637103.09
672754-7275494.52097.10
60min175457-7545798.03298.401.14101.15101.521.16
277152-77152100.234103.43
376435-7643599.303102.51
475091-7509197.557100.65
575098-7509897.566100.58
675214-7521497.716100.82
极限172033-7203393.58496.903.3297.24100.573.25
276784-7678499.756103.51
376946-7694699.966103.72
476793-7679399.768103.40
572547-7254794.25197.81
672415-7241594.08097.73
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