苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379209991825914699190891939918480.26
214.359206891860919640.16
单位质量响应值RSD%判断
6391.656408.640.19数据可信
供试品溶液-2024121111批-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%
5min179968-7996887.66785.533.6287.6785.533.62
274387-7438781.54981.55
380045-8004587.75187.75
474587-7458781.76881.77
580608-8060888.36888.37
678507-7850786.06586.07
10min182903-8290390.88492.103.3291.7692.963.31
279132-7913286.75087.57
385295-8529593.50794.38
483858-8385891.93192.75
586050-8605094.33495.22
686843-8684395.20496.06
15min184702-8470292.85792.642.2794.6494.422.28
282677-8267790.63792.32
383954-8395492.03793.85
482333-8233390.26092.00
587162-8716295.55397.38
686214-8621494.51496.33
20min183394-8339491.42391.781.9594.1494.481.96
282345-8234590.27392.86
383808-8380891.87794.61
482017-8201789.91392.55
586576-8657694.91197.69
684178-8417892.28295.04
30min184652-8465292.80292.021.5896.4395.641.61
281856-8185689.73793.23
384139-8413992.23995.89
483018-8301891.01194.55
585628-8562893.87297.60
684362-8436292.48496.16
45min182803-8280390.77591.420.9395.3395.960.97
282199-8219990.11394.50
384115-8411592.21396.79
483320-8332091.34295.79
584051-8405192.14396.81
683879-8387991.95496.56
60min181279-8127989.10490.791.7594.5796.251.72
281401-8140189.23894.53
385045-8504593.23398.73
482327-8232790.25395.62
583620-8362091.67097.26
683254-8325491.26996.79
极限181616-8161689.47491.341.5395.8397.701.48
282025-8202589.92296.10
383496-8349691.53597.96
484754-8475492.91499.18
584480-8448092.61399.12
683515-8351591.55597.99
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379192391893923019200791857919960.20
214.359206192343922020.22
单位质量响应值RSD%判断
6401.956425.230.26数据可信
供试品溶液-2024121111批-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%
5min177646-7764684.94385.681.8284.9485.681.82
279944-7994487.45787.46
379345-7934586.80286.80
476586-7658683.78383.78
577008-7700884.24584.25
679411-7941186.87486.87
10min186014-8601494.09792.422.4494.9593.282.42
285681-8568193.73394.61
382973-8297390.77191.64
484779-8477992.74693.58
581098-8109888.71989.56
686363-8636394.47995.35
15min184184-8418492.09592.901.4593.8994.681.45
286313-8631394.42596.24
384106-8410692.01093.79
484133-8413392.04093.80
584083-8408391.98593.71
686677-8667794.82396.64
20min184101-8410192.00592.220.9894.7294.931.00
285239-8523993.25096.01
383829-8382991.70794.40
483841-8384191.72094.41
583381-8338191.21793.87
685392-8539293.41796.18
30min183887-8388791.77192.882.4495.4096.512.39
284957-8495792.94196.63
383255-8325591.07994.69
485039-8503993.03196.63
583425-8342591.26594.83
688828-8882897.176100.87
45min184801-8480192.77091.581.3797.3296.141.31
285427-8542793.45598.07
383230-8323091.05295.58
483203-8320391.02295.56
583208-8320891.02895.50
682419-8241990.16594.83
60min184088-8408891.99091.291.3897.4796.761.32
284590-8459092.54098.09
384576-8457692.52497.96
483144-8314490.95896.40
581952-8195289.65495.04
682325-8232590.06295.63
极限184884-8488492.86191.880.9099.2698.260.83
284330-8433092.25598.73
384496-8449692.43798.80
483546-8354691.39897.75
583837-8383791.71698.00
682803-8280390.58597.05
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379207092297926059246691774922420.36
214.359174792154919500.32
单位质量响应值RSD%判断
6419.076407.670.13数据可信
供试品溶液-2024121611批-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%
5min167173-6717373.48881.156.9873.4981.156.98
272639-7263979.46879.47
382735-8273590.51390.51
475046-7504682.10182.10
571727-7172778.47078.47
675746-7574682.86782.87
10min181775-8177589.46390.573.9190.2091.383.90
276813-7681384.03484.83
384733-8473392.69993.60
483728-8372891.60092.42
583710-8371091.58092.36
685949-8594994.02994.86
15min181651-8165189.32790.894.0490.9692.604.04
277386-7738684.66186.30
387135-8713595.32797.16
483388-8338891.22892.96
583573-8357391.43093.13
685330-8533093.35295.12
20min181284-8128488.92690.423.8691.4593.053.87
277166-7716684.42186.90
386464-8646494.59397.38
483588-8358891.44694.10
582964-8296490.76493.38
684447-8444792.38695.09
30min181396-8139689.04890.613.7792.4694.143.77
277468-7746884.75188.08
385907-8590793.98397.71
482563-8256390.32593.89
584305-8430592.23195.75
685309-8530993.32996.96
45min181051-8105188.67189.022.6592.9793.452.70
277242-7724284.50488.68
383326-8332691.16095.83
481888-8188889.58794.05
582413-8241390.16194.61
682279-8227990.01494.57
60min181664-8166489.34289.512.8994.5394.832.92
277139-7713984.39189.41
383301-8330191.13296.72
482688-8268890.46295.82
583225-8322591.04996.40
682866-8286690.65796.12
极限185030-8503093.02489.862.1699.1196.082.06
280591-8059188.16894.03
383432-8343291.27697.77
481791-8179189.48095.75
581493-8149389.15495.41
680506-8050688.07594.44
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379209692384922139202092274921970.16
214.359235392461924070.09
单位质量响应值RSD%判断
6415.946439.510.26数据可信
供试品溶液-2024121611批-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%
5min171812-7181278.38881.415.6478.3981.415.64
273206-7320679.91079.91
379447-7944786.72286.72
479953-7995387.27487.27
569569-6956975.94075.94
673521-7352180.25380.25
10min179169-7916986.41990.293.1887.2091.103.19
284275-8427591.99292.79
385631-8563193.47294.34
484536-8453692.27793.15
579952-7995287.27388.03
682721-8272190.29691.10
15min180107-8010787.44390.813.1389.0992.523.15
284120-8412091.82393.54
386204-8620494.09895.90
485867-8586793.73095.53
580722-8072288.11489.75
682106-8210689.62591.33
20min180330-8033087.68690.032.5590.2192.662.59
283176-8317690.79393.43
384786-8478692.55095.29
484583-8458392.32895.06
579801-7980187.10989.62
682193-8219389.72092.32
30min179679-7967986.97590.372.7590.3793.892.77
284474-8447492.20995.75
385598-8559893.43697.10
483966-8396691.65595.31
580896-8089688.30491.69
682105-8210589.62493.12
45min180475-8047587.84489.102.0992.1193.532.14
282646-8264690.21494.68
383424-8342491.06395.67
482860-8286090.44895.02
578921-7892186.14890.42
681433-8143388.89093.29
60min179064-7906486.30489.401.9091.4594.711.94
282985-8298590.58495.95
382823-8282390.40795.92
482786-8278690.36795.84
581072-8107288.49693.62
682648-8264890.21695.50
极限181312-8131288.75889.731.1294.7795.951.04
281153-8115388.58494.86
382056-8205689.57095.99
482174-8217489.69996.08
583118-8311890.72996.74
683411-8341191.04997.24
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379041990686903939043690476904820.14
214.359039090256903230.11
单位质量响应值RSD%判断
6296.596294.290.03数据可信
供试品溶液-2024122311批-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%
5min169023-6902376.92782.149.8976.9382.149.89
265810-6581073.34673.35
366635-6663574.26574.27
481658-8165891.00891.01
579448-7944888.54588.55
679619-7961988.73688.74
10min177693-7769386.58991.724.9987.3692.545.03
277853-7785386.76887.50
380521-8052189.74190.48
486732-8673296.66397.57
585261-8526195.02495.91
685726-8572695.54296.43
15min178811-7881187.83592.033.7889.4793.773.84
279786-7978688.92290.52
380953-8095390.22391.86
486236-8623696.11197.99
584515-8451594.19296.03
685168-8516894.92096.76
20min177336-7733686.19191.013.4588.7093.673.51
279313-7931388.39590.89
381575-8157590.91693.46
484275-8427593.92596.76
583638-8363893.21595.99
683815-8381593.41296.20
30min178714-7871487.72791.023.1191.1094.593.19
279279-7927988.35791.73
380385-8038589.59093.04
483230-8323092.76096.54
583550-8355093.11796.83
684858-8485894.57598.30
45min178480-7848087.46690.532.3191.7295.012.38
279743-7974388.87493.13
382037-8203791.43195.78
482847-8284792.33397.04
580925-8092590.19194.83
683332-8333292.87497.55
60min176629-7662985.40389.683.2190.5395.063.26
277968-7796886.89692.04
380762-8076290.01095.27
482242-8224291.65997.29
582351-8235191.78197.32
682831-8283192.31697.92
极限182198-8219891.61092.480.9697.5998.761.07
283064-8306492.57598.59
382527-8252791.97798.14
484107-8410793.738100.28
582272-8227291.69398.15
683699-8369993.28399.81
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379186191909917549189591934918710.08
214.359160191656916280.05
单位质量响应值RSD%判断
6393.256385.230.09数据可信
供试品溶液-2024122311批-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%
5min176010-7601083.47081.895.7883.4781.895.78
271750-7175078.79278.79
379804-7980487.63687.64
467811-6781174.46674.47
577660-7766085.28285.28
674407-7440781.71081.71
10min183287-8328791.46189.963.4092.3090.783.42
280117-8011787.98088.77
385404-8540493.78694.66
477437-7743785.03785.78
582355-8235590.43891.29
682946-8294691.08791.90
15min179188-7918886.96090.892.6188.7192.612.56
282832-8283290.96192.63
385222-8522293.58695.40
483740-8374091.95993.55
581508-8150889.50891.26
684107-8410792.36294.09
20min178674-7867486.39590.152.3889.0192.782.34
283404-8340491.59094.17
383807-8380792.03294.78
482262-8226290.33692.85
581053-8105389.00891.66
683350-8335091.53094.18
30min179236-7923687.01390.182.3290.5093.712.30
281834-8183489.86693.36
384805-8480593.12896.80
481388-8138889.37692.79
581952-8195289.99593.54
683491-8349191.68595.25
45min179551-7955187.35889.411.5791.7193.841.57
281974-8197490.01994.41
383005-8300591.15195.75
481402-8140289.39193.70
580348-8034888.23492.68
682230-8223090.30094.78
60min178756-7875686.48588.612.3491.7193.932.22
282040-8204090.09295.38
382303-8230390.38195.89
482816-8281690.94496.15
579131-7913186.89792.22
679082-7908286.84392.23
极限182192-8219290.25990.790.7096.3597.000.70
282584-8258490.68996.88
382435-8243590.52696.94
482152-8215290.21596.33
583001-8300191.14797.34
683671-8367191.88398.14
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