苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法分装
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.044681140468318846860624685980467678746826310.09
216.064708637471126447099500.04
单位质量响应值RSD%判断
291934.60293272.100.33数据可信
供试品溶液-AR7108E批-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%
5min14040945-404094576.98477.533.0776.9877.533.07
24074171-407417177.61777.62
33877724-387772473.87573.87
44267288-426728881.29681.30
54057436-405743677.29877.30
64098730-409873078.08578.09
10min14961434-496143494.52192.731.3994.6592.861.39
24861950-486195092.62592.75
34764599-476459990.77190.89
44913993-491399393.61793.75
54866277-486627792.70892.84
64836531-483653192.14192.27
15min15077608-507760896.73494.581.3497.0294.861.34
24960585-496058594.50494.79
34882366-488236693.01493.29
44992703-499270395.11695.41
54929700-492970093.91694.20
64944062-494406294.19094.47
20min15085869-508586996.89194.971.0897.3495.421.09
24971815-497181594.71895.16
34947250-494725094.25094.68
45002954-500295495.31295.76
54942459-494245994.15994.60
64961087-496108794.51494.95
30min15091542-509154296.99995.071.1997.6195.681.19
24981520-498152094.90395.50
34914355-491435593.62494.21
45009589-500958995.43896.05
54958250-495825094.46095.06
64987524-498752495.01895.62
45min15101667-510166797.19295.431.1597.9696.191.15
24995148-499514895.16395.92
34932795-493279593.97594.72
45024884-502488495.72996.50
54974418-497441894.76895.52
65026064-502606495.75296.51
60min15103135-510313597.22095.601.0898.1596.521.08
25000596-500059695.26796.18
34946653-494665394.23995.14
45028387-502838795.79696.72
54984399-498439994.95895.87
65046238-504623896.13697.05
极限15225836-522583699.55898.921.28100.65100.001.28
25149207-514920798.09899.17
35136009-513600997.84698.90
45217587-521758799.401100.49
55128443-512844397.70298.77
65297717-5297717100.927102.00
苯磺酸左氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法分装
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.044715566472442047213394720182471582147194660.09
216.064706876470759347072340.02
单位质量响应值RSD%判断
294231.05293102.990.28数据可信
供试品溶液-AR7108E批-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%
5min14386279-438627983.26079.714.8583.2679.714.85
24402616-440261683.57183.57
34128538-412853878.36878.37
44126305-412630578.32678.33
54287639-428763981.38881.39
63863490-386349073.33773.34
10min15033393-503339395.54493.471.9995.6893.602.00
24991632-499163294.75194.89
34954379-495437994.04494.17
44879371-487937192.62092.75
54930616-493061693.59393.73
64755367-475536790.26790.39
15min15100398-510039896.81695.181.6497.1195.471.64
25075384-507538496.34196.64
35046125-504612595.78696.07
44983930-498393094.60594.89
55007828-500782895.05995.35
64871353-487135392.46892.74
20min15109064-510906496.98095.381.6197.4495.831.61
25085313-508531396.53096.99
35061603-506160396.07996.53
44990801-499080194.73695.18
55016378-501637895.22195.67
64886424-488642492.75493.18
30min15115600-511560097.10495.551.5497.7396.151.55
25093978-509397896.69497.31
35060679-506067996.06296.67
45009450-500945095.09095.69
55022239-502223995.33295.94
64899463-489946393.00293.58
45min15125235-512523597.28795.781.5198.0796.551.52
25107040-510704096.94297.72
35074470-507447096.32497.09
45020701-502070195.30396.06
55035100-503510095.57696.34
64913958-491395893.27794.01
60min15131787-513178797.41295.951.4498.3696.881.44
25114014-511401497.07498.02
35077403-507740396.37997.31
45034708-503470895.56996.49
55040042-504004295.67096.60
64929845-492984593.57894.47
极限15225302-522530299.18798.740.55100.2999.820.55
25214499-521449998.982100.08
35212931-521293198.952100.04
45221028-522102899.106100.18
55152119-515211997.79898.88
65184808-518480898.41899.47
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