比索洛尔氨氯地平片项目信息
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10071-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.358531885636858328548085504855540.23
210.218588586367861260.40
单位质量响应值RSD%判断
8266.098435.461.44数据可信
供试品溶液-24093001批-比索洛尔-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%
5min188386-8838695.07794.532.9295.0894.532.92
286715-8671593.27993.28
390671-9067197.53597.53
485273-8527391.72891.73
590981-9098197.86897.87
685248-8524891.70191.70
10min189703-8970396.49496.092.7396.6596.252.74
288089-8808994.75794.91
391765-9176598.71298.87
486141-8614192.66292.81
592447-9244799.44599.61
687836-8783694.48594.64
15min190471-9047197.32096.302.6597.6496.622.65
288336-8833695.02395.34
391283-9128398.19398.52
486111-8611192.63092.94
592615-9261599.62699.95
688316-8831695.00295.31
20min190168-9016896.99496.272.8597.4896.752.85
288362-8836295.05195.52
391373-9137398.29098.78
485419-8541991.88592.35
592698-9269899.715100.21
688965-8896595.70096.17
30min190511-9051197.36396.032.7298.0196.672.72
288140-8814094.81295.44
391049-9104997.94198.60
485304-8530491.76292.38
591968-9196898.93099.59
688678-8867895.39196.02
45min190488-9048897.33896.012.8398.1496.812.83
287762-8776294.40695.19
391292-9129298.20399.02
485250-8525091.70392.47
592015-9201598.98199.81
688712-8871295.42796.21
极限190076-9007696.89595.752.6097.8696.712.60
287549-8754994.17695.12
390871-9087197.75098.73
485472-8547291.94292.86
591664-9166498.60399.59
688457-8845795.15396.10
比索洛尔氨氯地平片项目信息
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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.121069681062521073711067231059131066450.55
213.991063071056121059600.47
单位质量响应值RSD%判断
7552.767573.980.20数据可信
供试品溶液-24093001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%
5min166457-6645756.96854.727.5056.9754.727.50
266751-6675157.22057.22
360719-6071952.04952.05
470643-7064360.55660.56
559538-5953851.03751.04
658889-5888950.48050.48
10min186396-8639674.06071.966.3374.1572.056.33
284081-8408172.07572.17
382375-8237570.61370.70
492960-9296079.68779.79
578330-7833067.14667.23
679520-7952068.16668.25
15min193921-9392180.51076.595.4180.7376.805.41
289162-8916276.43176.65
387687-8768775.16675.37
496176-9617682.44382.68
584071-8407172.06772.26
685064-8506472.91873.12
20min192942-9294279.67178.515.0580.0278.855.05
291158-9115878.14278.48
388782-8878276.10576.43
4100008-10000885.72886.10
589818-8981876.99377.31
686814-8681474.41874.74
30min197675-9767583.72880.385.1284.2180.845.13
293102-9310279.80880.28
392676-9267679.44379.90
4101072-10107286.64087.15
589131-8913176.40476.85
688929-8892976.23176.67
45min199414-9941485.21983.145.3685.8483.745.36
295740-9574082.07082.68
399633-9963385.40786.00
4104492-10449289.57290.23
591255-9125578.22578.80
691404-9140478.35378.92
极限1106929-10692991.66190.064.7092.4390.814.70
2105429-10542990.37591.12
3102453-10245387.82488.56
4113233-11323397.06597.87
598501-9850184.43685.14
6103848-10384889.02089.72
比索洛尔氨氯地平片项目信息
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10071-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.358536485783855798554285392855320.20
210.218619885576858870.52
单位质量响应值RSD%判断
8263.968412.051.26数据可信
供试品溶液-24093002批-比索洛尔-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%
5min188718-8871895.57893.191.5595.5893.201.55
285487-8548792.09792.10
386970-8697093.69593.69
484921-8492191.48791.49
586829-8682993.54393.54
686109-8610992.76792.77
10min190336-9033697.32194.701.5197.4894.851.51
287050-8705093.78193.93
387867-8786794.66194.82
486723-8672393.42993.58
588277-8827795.10395.26
687154-8715493.89394.05
15min190389-9038997.37895.171.5097.7095.481.50
288650-8865095.50595.81
388395-8839595.23095.54
486878-8687893.59693.90
588837-8883795.70696.02
686905-8690593.62593.94
20min190339-9033997.32495.121.5997.8195.591.59
287782-8778294.56995.04
388403-8840395.23895.71
486860-8686093.57694.04
589475-8947596.39396.87
686900-8690093.61994.09
30min191866-9186698.96995.392.1299.6296.022.12
287827-8782794.61895.24
388832-8883295.70196.33
486884-8688493.60294.22
589020-8902095.90396.54
686823-8682393.53694.16
45min189975-8997596.93294.881.6997.7495.661.69
287302-8730294.05294.84
388459-8845995.29996.09
486618-8661893.31594.09
589532-8953296.45597.25
686510-8651093.19993.98
极限189483-8948396.40294.571.4297.3795.521.42
287202-8720293.94594.89
387996-8799694.80095.75
486550-8655093.24294.17
588931-8893195.80796.76
686523-8652393.21394.15
比索洛尔氨氯地平片项目信息
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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.121069561060841050121058631055631058960.68
213.991055771070511063140.99
单位质量响应值RSD%判断
7499.727599.290.94数据可信
供试品溶液-24093002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%
5min164548-6454855.43554.755.3355.4454.755.33
257749-5774949.59649.60
364188-6418855.12655.13
462365-6236553.56153.56
567020-6702057.55857.56
666621-6662157.21657.22
10min184260-8426072.36573.051.6572.4673.141.66
283395-8339571.62271.70
385357-8535773.30773.40
485728-8572873.62573.71
584268-8426872.37172.47
687352-8735275.02075.12
15min188207-8820775.75476.852.3975.9777.072.39
285869-8586973.74673.95
390894-9089478.06278.28
490249-9024977.50877.72
589900-8990077.20877.42
691802-9180278.84279.06
20min192062-9206279.06579.702.4979.4080.042.49
288636-8863676.12376.45
394239-9423980.93581.28
493407-9340780.22080.56
593186-9318680.03080.38
695256-9525681.80882.16
30min196461-9646182.84381.551.9883.3182.021.98
291359-9135978.46178.91
396237-9623782.65183.13
494967-9496781.56082.03
594894-9489481.49781.98
695805-9580582.28082.77
45min196790-9679083.12684.002.5383.7384.622.53
294754-9475481.37781.96
399278-9927885.26285.88
497717-9771783.92284.53
596506-9650682.88283.50
6101838-10183887.46188.09
极限1102588-10258888.10591.223.5688.8591.963.55
2103090-10309088.53689.25
3108757-10875793.40394.16
4104921-10492190.10990.86
5105394-10539490.51591.27
6112514-11251496.63097.40
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