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%
113.948939289875884908881088330889790.73
214.018822788222882240.01
单位质量响应值RSD%判断
6383.006297.220.96数据可信
中间条件36月-供试品溶液-2022032901批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180287-8028788.85486.373.9688.8586.373.96
278426-7842686.79486.79
379177-7917787.62687.63
472036-7203679.72379.72
578037-7803786.36486.36
680280-8028088.84688.85
10min187977-8797797.36595.571.8298.2596.431.80
284406-8440693.41294.28
387779-8777997.14598.02
487202-8720296.50797.30
586173-8617395.36896.23
684599-8459993.62694.51
15min186347-8634795.56195.141.7697.4296.961.72
286940-8694096.21798.02
385403-8540394.51696.36
486118-8611895.30797.07
587667-8766797.02198.84
683318-8331892.20894.03
20min185750-8575094.90093.713.4897.7296.483.40
282773-8277391.60594.37
384507-8450793.52496.32
483679-8367992.60895.32
589884-8988499.475102.26
681442-8144290.13292.88
30min182191-8219190.96192.322.4394.7396.032.36
281498-8149890.19493.87
383952-8395292.91096.64
485233-8523394.32897.97
586210-8621095.40999.19
681444-8144490.13493.78
45min182767-8276791.59991.982.9096.2896.612.83
281423-8142390.11194.69
384133-8413393.11097.77
484061-8406193.03197.62
586602-8660295.843100.58
679661-7966188.16192.71
60min183257-8325792.14191.152.7097.7396.702.64
280869-8086989.49894.98
381675-8167590.39095.98
483207-8320792.08697.60
585775-8577594.928100.62
679388-7938887.85993.29
极限181736-8173690.45889.793.2496.9796.253.15
278934-7893487.35793.73
381813-8181390.54397.04
481128-8112889.78596.22
585356-8535694.464101.11
677817-7781786.12092.43
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%
113.948919289353881948905389007889600.51
214.018950089785896420.23
单位质量响应值RSD%判断
6381.646398.430.19数据可信
中间条件36月-供试品溶液-2022033001批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min175603-7560383.01388.128.1583.0188.128.15
290626-9062699.50899.51
375087-7508782.44682.45
486262-8626294.71694.72
577233-7723384.80384.80
676699-7669984.21684.22
10min185820-8582094.23195.912.3695.0696.792.38
290797-9079799.696100.69
388990-8899097.71298.54
486058-8605894.49295.44
586229-8622994.68095.53
686195-8619594.64395.49
15min184971-8497193.29996.142.0495.0797.982.07
290479-9047999.347101.34
387084-8708495.61997.42
487644-8764496.23498.13
587172-8717295.71697.51
688015-8801596.64198.43
20min184666-8466692.96494.341.5095.6797.151.50
287098-8709895.63498.62
384606-8460692.89895.66
485015-8501593.34796.20
587254-8725495.80698.56
686901-8690195.41898.17
30min184976-8497693.30493.751.4896.9497.501.46
286700-8670095.19799.14
386340-8634094.80298.49
483592-8359291.78595.57
584360-8436092.62896.34
686324-8632494.78598.49
45min183600-8360091.79492.031.4396.3696.711.41
285270-8527093.62798.52
384983-8498393.31297.95
481971-8197190.00594.71
583586-8358691.77896.41
683475-8347591.65696.31
60min181499-8149989.48791.792.4394.9797.392.35
285068-8506893.40599.24
386692-8669295.189100.76
483504-8350491.68897.29
581537-8153789.52895.08
683273-8327391.43597.01
极限181896-8189689.92390.783.2596.3097.303.14
287739-8773996.338103.10
381132-8113289.08495.60
479955-7995587.79194.31
582815-8281590.93297.38
682547-8254790.63797.13
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%
113.948840089463890318825588758887810.55
214.018836787415878910.77
单位质量响应值RSD%判断
6368.796273.451.07数据可信
中间条件36月-供试品溶液-2022033101批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179398-7939888.13590.644.6088.1490.644.60
278688-7868887.34787.35
383728-8372892.94192.94
478685-7868587.34487.34
588230-8823097.93997.94
681222-8122290.16090.16
10min188575-8857598.32295.642.8199.2096.552.78
285945-8594595.40296.28
381567-8156790.54391.47
486631-8663196.16497.04
586813-8681396.36697.35
687435-8743597.05697.96
15min188743-8874398.50895.692.58100.3797.552.56
285438-8543894.84096.67
383584-8358492.78294.62
485831-8583195.27697.11
589024-8902498.820100.76
684588-8458893.89695.77
20min187345-8734596.95793.863.7299.8196.683.66
284930-8493094.27697.05
378792-7879287.46290.22
484619-8461993.93196.72
587394-8739497.01199.94
684270-8427093.54396.35
30min183594-8359492.79392.732.8296.6196.492.80
281795-8179590.79694.51
380199-8019989.02492.66
483577-8357792.77496.50
586761-8676196.308100.21
685303-8530394.69098.44
45min184513-8451393.81392.322.7798.5697.012.74
281081-8108190.00394.63
379510-7951088.25992.79
484265-8426593.53898.19
585176-8517694.54999.41
684486-8448693.78398.48
60min181794-8179490.79591.041.9096.4896.651.90
283150-8315092.30097.83
379170-7917087.88293.29
481799-8179990.80096.39
583493-8349392.68198.49
682689-8268991.78897.42
极限181641-8164190.62590.551.1697.2297.071.17
280384-8038489.23095.68
381268-8126890.21196.50
480907-8090789.81096.31
582265-8226591.31898.05
682982-8298292.11398.66
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