苯磺酸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%
114.379075690337904019029690292904160.22
214.359041090563904860.12
单位质量响应值RSD%判断
6292.006305.640.16数据可信
供试品溶液-2024121111批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167327-6732774.99682.018.0075.0082.018.00
265391-6539172.84072.84
379029-7902988.03188.03
477861-7786186.73086.73
577880-7788086.75186.75
674256-7425682.71482.71
10min177395-7739586.21191.853.7086.9692.673.72
280392-8039289.54990.28
384891-8489194.56195.44
482574-8257491.98092.85
584833-8483394.49695.36
684665-8466594.30995.14
15min178513-7851387.45691.702.8189.0793.442.85
280792-8079289.99591.62
384218-8421893.81195.64
482270-8227091.64193.43
583942-8394293.50495.32
684206-8420693.79895.57
20min179147-7914788.16391.832.3190.6594.482.37
281295-8129590.55593.08
384123-8412393.70596.47
482766-8276692.19494.90
583854-8385493.40696.15
683427-8342792.93095.64
30min178623-7862387.57990.942.1490.9594.522.20
280520-8052089.69293.12
382771-8277192.19995.90
482103-8210391.45595.08
582941-8294192.38996.07
682900-8290092.34395.98
45min177248-7724886.04790.292.6790.2994.772.71
279654-7965488.72793.05
382629-8262992.04196.66
482293-8229391.66796.21
582443-8244391.83496.44
682049-8204991.39595.96
60min177694-7769486.54488.911.5791.6594.301.67
279085-7908588.09393.31
380569-8056989.74795.29
479989-7998989.10094.56
581171-8117190.41795.94
680400-8040089.55895.03
极限180960-8096090.18288.700.9296.1594.970.75
279322-7932288.35794.45
379277-7927788.30794.75
479356-7935688.39594.74
579930-7993089.03595.46
678920-7892087.91094.28
苯磺酸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%
114.378986190127903139015290252901410.20
214.359009390132901120.04
单位质量响应值RSD%判断
6272.866279.580.08数据可信
供试品溶液-2024121111批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166108-6610873.90382.106.6473.9082.106.65
278554-7855487.81787.82
375800-7580084.73884.74
473369-7336982.02182.02
569321-6932177.49577.50
677491-7749186.62986.63
10min179018-7901888.33692.092.8889.0792.912.90
283931-8393193.82894.71
384466-8446694.42695.27
480053-8005389.49390.31
582291-8229191.99592.77
684516-8451694.48295.35
15min179035-7903588.35592.032.7289.9893.772.74
283560-8356093.41395.23
384066-8406693.97995.77
480109-8010989.55591.27
582702-8270292.45494.15
684442-8444294.39996.21
20min179656-7965689.04991.981.9791.5594.642.03
283335-8333593.16295.91
383450-8345093.29096.02
481377-8137790.97393.58
581890-8189091.54694.17
683951-8395193.85096.61
30min179519-7951988.89691.191.5392.2994.771.59
282340-8234092.04995.73
382812-8281292.57796.24
481060-8106090.61894.14
581169-8116990.74094.28
682537-8253792.27095.96
45min178522-7852287.78190.261.9192.0794.761.95
282121-8212191.80596.41
381679-8167991.31095.90
479265-7926588.61293.04
580724-8072490.24394.69
682133-8213391.81896.43
60min178002-7800287.20089.301.3792.3694.701.44
280582-8058290.08495.60
380616-8061690.12295.63
479096-7909688.42393.74
580409-8040989.89195.24
680604-8060490.10995.64
极限179707-7970789.10688.760.2895.1495.050.15
279205-7920588.54594.97
379469-7946988.84095.24
479556-7955688.93795.13
579337-7933788.69294.94
679121-7912188.45194.89
苯磺酸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%
114.379032390245902879030390283902880.04
214.359012290176901490.05
单位质量响应值RSD%判断
6283.096282.160.02数据可信
供试品溶液-2024121611批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172179-7217980.60877.3910.3280.6177.4010.33
276242-7624285.14585.15
364603-6460372.14772.15
463186-6318670.56570.56
578143-7814387.26887.27
661458-6145868.63568.63
10min178179-7817987.30987.606.0288.1188.386.05
281787-8178791.33892.19
379085-7908588.32089.04
471650-7165080.01780.72
584916-8491694.83295.71
675043-7504383.80684.49
15min178909-7890988.12488.034.9889.8089.685.02
281975-8197591.54893.31
379342-7934288.60790.21
472348-7234880.79782.30
583427-8342793.17094.99
676957-7695785.94487.47
20min178802-7880288.00488.223.9990.5690.764.05
280703-8070390.12792.81
380370-8037089.75692.25
473701-7370182.30884.62
582824-8282492.49695.25
677591-7759186.65289.04
30min179494-7949488.77788.634.0792.2292.044.12
280509-8050989.91193.49
381094-8109490.56493.95
473914-7391482.54685.68
583322-8332293.05296.73
677858-7785886.95090.20
45min177708-7770886.78388.253.1491.1192.553.21
280704-8070490.12994.61
380510-8051089.91294.21
474953-7495383.70687.67
581687-8168791.22695.83
678572-7857287.74891.87
60min176827-7682785.79987.272.5890.9992.452.69
279337-7933788.60293.98
377797-7779786.88292.08
475318-7531884.11488.91
581138-8113890.61396.13
678430-7843087.58992.59
极限177289-7728986.31588.711.8092.3794.761.86
280279-8027989.65495.92
380527-8052789.93195.99
479208-7920888.45894.10
580975-8097590.43196.86
678301-7830187.44593.32
苯磺酸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%
114.379036190195902639028590166902540.09
214.359073090980908550.20
单位质量响应值RSD%判断
6280.726331.360.57数据可信
供试品溶液-2024121611批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173940-7394082.26977.427.7682.2777.427.76
264365-6436571.61671.62
372223-7222380.35980.36
466693-6669374.20674.21
576590-7659085.21885.22
663672-6367270.84570.84
10min180134-8013489.16187.364.2289.9888.134.24
275591-7559184.10684.82
380953-8095390.07290.88
474623-7462383.02983.77
582944-8294492.28893.14
676849-7684985.50686.21
15min180407-8040789.46588.163.4791.1889.813.50
277335-7733586.04787.60
380614-8061489.69591.40
475214-7521483.68785.26
583023-8302392.37694.15
678814-7881487.69289.26
20min179920-7992088.92388.293.6891.5390.823.71
276732-7673285.37687.79
382359-8235991.63794.24
475472-7547283.97486.38
582692-8269292.00794.71
678939-7893987.83190.27
30min179936-7993688.94187.972.6892.4491.382.73
277087-7708785.77189.04
380703-8070389.79493.31
475929-7592984.48287.73
581309-8130990.46894.09
679410-7941088.35691.67
45min179288-7928888.22088.542.4292.6192.832.45
279947-7994788.95393.08
380902-8090290.01694.43
476170-7617084.75188.84
581769-8176990.98095.50
679397-7939788.34192.54
60min178873-7887387.75887.102.4293.0392.282.48
276210-7621084.79589.81
380019-8001989.03394.35
475852-7585284.39789.34
580354-8035489.40694.84
678369-7836987.19792.28
极限179135-7913588.05088.840.8694.2094.890.96
279855-7985588.85194.72
380046-8004689.06395.27
479095-7909588.00593.79
580937-8093790.05596.38
680031-8003189.04695.00
苯磺酸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%
114.379038590231903739017290352903030.11
214.359064390655906490.01
单位质量响应值RSD%判断
6284.136317.000.37数据可信
供试品溶液-2024122311批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167233-6723374.87180.705.7074.8780.705.70
273450-7345081.79481.79
372786-7278681.05581.05
469396-6939677.28077.28
572592-7259280.83980.84
679348-7934888.36288.36
10min179920-7992088.99990.832.7389.7591.642.73
282022-8202291.34092.16
380065-8006589.16189.97
479429-7942988.45389.23
585274-8527494.96295.77
682694-8269492.08992.97
15min178519-7851987.43989.962.4889.0891.682.48
282243-8224391.58693.32
379026-7902688.00489.71
479976-7997689.06290.72
583747-8374793.26195.02
681202-8120290.42792.23
20min177962-7796286.81988.952.2189.3391.572.22
280703-8070389.87192.52
377991-7799186.85189.43
479235-7923588.23790.78
582214-8221491.55494.24
681166-8116690.38793.10
30min177299-7729986.08188.251.9589.4691.761.97
280254-8025489.37192.92
378275-7827587.16890.62
478516-7851687.43690.87
581595-8159590.86594.47
679565-7956588.60492.22
45min178764-7876487.71288.251.7491.9592.641.77
279430-7943088.45492.89
377768-7776886.60390.93
477848-7784886.69291.00
580999-8099990.20194.72
680665-8066589.82994.33
60min176650-7665085.35887.071.9090.4892.341.91
278951-7895187.92093.24
377576-7757686.38991.58
476682-7668285.39490.57
580401-8040189.53594.95
678857-7885787.81693.21
极限178433-7843387.34386.741.4893.3292.881.46
278133-7813387.00993.21
377740-7774086.57292.62
475736-7573684.34090.37
579087-7908788.07294.38
678227-7822787.11493.39
苯磺酸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%
114.379095990979909119078090947909150.09
214.359117891108911430.06
单位质量响应值RSD%判断
6326.726351.430.28数据可信
供试品溶液-2024122311批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176724-7672484.92180.303.9584.9280.303.95
271039-7103978.62978.63
372764-7276480.53880.54
474685-7468582.66482.66
571498-7149879.13779.14
668596-6859675.92575.92
10min183555-8355592.48290.532.5093.3391.332.51
280703-8070389.32590.11
383288-8328892.18692.99
483967-8396792.93893.76
579693-7969388.20789.00
679528-7952888.02588.78
15min180272-8027288.84889.541.5590.6291.241.56
280728-8072889.35391.03
382374-8237491.17592.90
482494-8249491.30793.06
579984-7998488.52990.20
679527-7952788.02489.66
20min179501-7950187.99589.582.8690.6692.192.77
279440-7944087.92790.50
381694-8169490.42293.06
482021-8202190.78493.45
578316-7831686.68389.24
684646-8464693.68996.21
30min179447-7944787.93588.251.8291.4891.761.80
279844-7984488.37491.83
381665-8166590.39093.93
481025-8102589.68293.26
578644-7864487.04690.47
677791-7779186.10289.56
45min179413-7941387.89787.921.5392.3292.301.53
278876-7887687.30391.64
380793-8079389.42593.87
480963-8096389.61394.09
578042-7804286.38090.68
678496-7849686.88291.20
60min179292-7929287.76387.091.6093.0692.351.60
278043-7804386.38191.59
380273-8027388.84994.19
479742-7974288.26193.63
577459-7745985.73590.89
677289-7728985.54690.73
极限178235-7823586.59386.670.5992.7792.800.65
278243-7824386.60292.68
378525-7852586.91493.14
479087-7908787.53693.79
577796-7779686.10892.12
677962-7796286.29192.33
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