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(%)99.70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%
110.782912702920162913332921402918012917120.14
210.762906362901492903920.12
单位质量响应值RSD%判断
27060.4826988.100.19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%
5min1195893-19589365.04363.9217.0665.0463.9217.06
2212129-21212970.43470.43
3181162-18116260.15260.15
4214309-21430971.15871.16
5219582-21958272.90972.91
6132049-13204943.84543.84
10min1303413-303413100.744101.822.03101.11102.172.07
2303467-303467100.762101.15
3303443-303443100.754101.09
4312725-312725103.836104.23
5316151-316151104.973105.38
6300690-30069099.840100.08
15min1305131-305131101.314102.111.55102.24103.041.57
2309936-309936102.910103.86
3300714-30071499.848100.74
4308164-308164102.321103.29
5314810-314810104.528105.52
6306470-306470101.759102.56
20min1309942-309942102.912102.571.31104.40104.061.35
2305943-305943101.584103.11
3307203-307203102.002103.45
4310897-310897103.229104.77
5315336-315336104.703106.27
6304122-304122100.979102.34
30min1309938-309938102.910102.362.40104.97104.422.35
2296105-29610598.317100.40
3307766-307766102.189104.20
4306067-306067101.625103.74
5318649-318649105.803107.95
6311143-311143103.310105.23
45min1300210-30021099.680102.611.64102.31105.241.63
2308437-308437102.412105.05
3309007-309007102.601105.18
4311599-311599103.462106.14
5315618-315618104.796107.53
6309340-309340102.712105.21
60min1302242-302242100.355102.121.33103.54105.321.33
2304596-304596101.137104.34
3305628-305628101.479104.63
4310337-310337103.043106.30
5313174-313174103.985107.31
6309322-309322102.706105.77
极限1301432-301432100.086101.341.62103.82105.111.64
2303121-303121100.647104.41
3305929-305929101.579105.30
4307437-307437102.080105.91
5313499-313499104.093107.99
6299875-29987599.569103.21
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(%) 99.90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%
115.447491075029751207506175001750240.11
215.547500574636748200.35
单位质量响应值RSD%判断
4859.074814.670.65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%
5min158510-5851078.42979.774.6978.4379.774.69
260273-6027380.79380.79
362161-6216183.32383.32
461730-6173082.74682.75
559895-5989580.28680.29
654496-5449673.04973.05
10min167522-6752290.50992.942.8490.9593.392.83
267009-6700989.82290.27
370591-7059194.62395.09
470434-7043494.41394.87
571992-7199296.50196.95
668483-6848391.79892.20
15min170127-7012794.00194.191.8994.9495.161.87
271072-7107295.26896.22
369863-6986393.64794.64
468203-6820391.42292.41
572184-7218496.75997.74
670171-7017194.06094.98
20min172012-7201296.52895.781.5797.9997.261.56
269929-6992993.73695.21
372823-7282397.61599.12
470812-7081294.91996.41
572374-7237497.01398.53
670778-7077894.87496.31
30min171860-7186096.32495.092.6398.3297.102.58
267874-6787490.98192.98
373129-7312998.025100.08
469904-6990493.70295.72
570811-7081194.91896.98
672057-7205796.58898.55
45min170912-7091295.05396.122.3497.5998.662.30
270457-7045794.44496.95
372546-7254697.24499.84
469589-6958993.28095.82
574103-7410399.331101.92
672639-7263997.36899.87
60min168155-6815591.35895.953.6194.4299.033.54
271151-7115195.37498.40
374220-7422099.488102.62
470754-7075494.84297.90
575022-75022100.563103.70
670196-7019694.09497.14
极限168019-6801991.17695.204.1094.7498.814.01
267199-6719990.07693.63
372509-7250997.194100.88
471623-7162396.00799.59
574964-74964100.485104.18
671817-7181796.26799.83
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)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(%)99.70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%
110.782912852906632908822910762908922909600.09
210.762897722895822896770.05
单位质量响应值RSD%判断
26990.7226921.650.19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%
5min1202267-20226767.32958.0319.7967.3358.0319.80
2162773-16277354.18354.18
3119784-11978439.87339.87
4211271-21127170.32770.33
5193570-19357064.43464.43
6156287-15628752.02452.02
10min1312999-312999104.189103.422.06104.56103.742.10
2314860-314860104.809105.11
3298141-29814199.24399.46
4314659-314659104.742105.13
5310198-310198103.257103.61
6313338-313338104.302104.59
15min1296597-29659798.729103.332.3999.68104.222.36
2316022-316022105.196106.08
3308111-308111102.562103.34
4314024-314024104.530105.50
5311680-311680103.750104.68
6316008-316008105.191106.06
20min1312329-312329103.966103.001.94105.47104.471.91
2299612-29961299.733101.20
3308384-308384102.653104.00
4309393-309393102.989104.54
5308901-308901102.825104.33
6317937-317937105.833107.29
30min1297158-29715898.916102.842.34101.00104.892.31
2309652-309652103.075105.10
3305003-305003101.528103.44
4312211-312211103.927106.05
5311219-311219103.597105.68
6318456-318456106.006108.05
45min1302809-302809100.797102.221.32103.43104.831.31
2308974-308974102.849105.44
3304489-304489101.356103.83
4309546-309546103.040105.74
5303592-303592101.058103.71
6313013-313013104.194106.82
60min1298976-29897699.521101.301.94102.71104.481.92
2308433-308433102.669105.84
3298386-29838699.325102.37
4306480-306480102.019105.29
5300660-300660100.082103.30
6312976-312976104.182107.39
极限1299899-29989999.829101.952.01103.57105.701.98
2303874-303874101.152104.89
3300341-30034199.976103.57
4308448-308448102.674106.52
5315934-315934105.166108.94
6309113-309113102.896106.68
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(%) 99.90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%
115.447485174906749137483675154749320.18
215.547491274792748520.12
单位质量响应值RSD%判断
4853.114816.730.54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%
5min160253-6025380.79882.335.8580.8082.335.85
261923-6192383.03783.04
357995-5799577.77077.77
467461-6746190.46390.46
557887-5788777.62577.62
662859-6285984.29284.29
10min170745-7074594.86795.131.9695.3295.581.97
272944-7294497.81698.28
370086-7008693.98494.42
471749-7174996.21496.72
568909-6890992.40592.84
671191-7119195.46595.93
15min167827-6782790.95496.413.4491.9397.403.43
273327-7332798.33099.33
371082-7108295.31996.27
475068-75068100.664101.70
571257-7125795.55496.50
672812-7281297.63998.64
20min168157-6815791.39795.652.4992.8897.172.48
271228-7122895.51597.07
372080-7208096.65798.14
473491-7349198.550100.15
571101-7110195.34596.82
671906-7190696.42497.97
30min168559-6855991.93696.062.2793.9298.112.24
271269-7126995.57097.65
373010-7301097.90599.93
472077-7207796.65398.80
572739-7273997.54199.55
672141-7214196.73998.82
45min170622-7062294.70296.891.6097.2099.471.61
272403-7240397.09199.70
372766-7276697.577100.14
473930-7393099.138101.82
571348-7134895.67698.22
672444-7244497.14699.76
60min167106-6710689.98796.513.6093.0199.643.55
272876-7287697.725100.88
372594-7259497.347100.45
474746-74746100.232103.46
571629-7162996.05399.13
672875-7287597.723100.88
极限166736-6673689.49196.464.1193.02100.124.03
270806-7080694.94998.64
373186-7318698.141101.79
475076-75076100.675104.46
573921-7392199.126102.74
671876-7187696.384100.08
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(%)99.70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%
110.782910762903792907362904802908872907120.10
210.762902602902342902470.01
单位质量响应值RSD%判断
26967.7226974.630.02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%
5min1202944-20294467.51760.1011.7467.5260.1011.74
2170624-17062456.76556.76
3204814-20481468.13968.14
4188838-18883862.82462.82
5158382-15838252.69252.69
6158213-15821352.63652.64
10min1314445-314445104.612105.341.84104.99105.681.85
2312133-312133103.843104.16
3323467-323467107.614107.99
4321408-321408106.929107.28
5308619-308619102.674102.97
6319775-319775106.385106.68
15min1313424-313424104.273105.851.92105.23106.771.93
2314974-314974104.788105.68
3323085-323085107.487108.46
4323888-323888107.754108.70
5310016-310016103.139104.00
6323657-323657107.677108.56
20min1313758-313758104.384105.691.87105.92107.201.87
2315259-315259104.883106.36
3322060-322060107.146108.72
4320509-320509106.630108.17
5309291-309291102.898104.33
6325273-325273108.215109.70
30min1312962-312962104.119105.161.94106.23107.251.94
2312213-312213103.870105.93
3321058-321058106.812108.98
4320038-320038106.473108.61
5307333-307333102.246104.25
6322856-322856107.410109.49
45min1304355-304355101.255106.352.70103.95109.022.65
2315332-315332104.907107.54
3325073-325073108.148110.91
4327388-327388108.918111.64
5320879-320879106.753109.33
6324923-324923108.098110.78
60min1312727-312727104.041105.701.92107.30108.981.92
2312066-312066103.821107.04
3325782-325782108.384111.75
4321434-321434106.937110.27
5312213-312213103.870107.04
6322151-322151107.176110.46
极限1299650-29965099.690104.953.77103.52108.803.70
2309420-309420102.940106.73
3329726-329726109.696113.66
4326737-326737108.702112.63
5307170-307170102.192105.94
6319973-319973106.451110.33
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(%) 99.90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%
115.447490474532747957464275101747950.30
215.547503674798749170.23
单位质量响应值RSD%判断
4844.244820.910.35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%
5min164655-6465586.74285.947.8586.7485.947.85
266367-6636789.03989.04
368628-6862892.07292.07
466990-6699089.87589.87
554563-5456373.20273.20
663158-6315884.73484.73
10min172524-7252497.29997.381.1697.7897.861.19
272975-7297597.90498.40
373710-7371098.89099.40
472923-7292397.83498.33
571251-7125195.59196.00
672114-7211496.74997.22
15min173463-7346398.55997.563.0099.5898.582.99
274100-7410099.414100.45
375141-75141100.810101.87
469275-6927592.94093.98
570959-7095995.20096.14
673364-7336498.42699.43
20min173847-7384799.07497.814.06100.6499.364.03
276396-76396102.494104.08
374207-7420799.557101.18
468514-6851491.91993.48
570128-7012894.08595.55
674316-7431699.703101.26
30min175566-75566101.380100.621.94103.50102.721.96
277176-77176103.540105.70
375766-75766101.649103.82
474180-7418099.521101.59
573116-7311698.093100.08
674172-7417299.510101.62
45min171394-7139495.783100.593.1698.47103.263.05
275725-75725101.594104.33
376471-76471102.595105.33
476065-76065102.050104.67
577462-77462103.924106.46
672754-7275497.608100.27
60min175457-75457101.234101.621.14104.45104.841.16
277152-77152103.508106.81
376435-76435102.546105.85
475091-75091100.743103.93
575098-75098100.752103.86
675214-75214100.908104.11
极限172033-7203396.640100.073.33100.42103.853.25
276784-76784103.014106.89
376946-76946103.232107.11
476793-76793103.027106.78
572547-7254797.330101.00
672415-7241597.153100.92
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