富马酸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%
110.098230982401824608253282502824410.11
210.128314383215831790.07
单位质量响应值RSD%判断
8170.568219.270.43数据可信
长期18月-供试品溶液-2022110211批-富马酸比索洛尔-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178695-7869586.25487.265.2186.2587.265.21
278708-7870886.26886.27
374789-7478981.97381.97
477332-7733284.76084.76
581290-8129089.09889.10
686889-8688995.23595.24
10min191031-9103199.77598.501.7399.9298.641.73
288282-8828296.76296.91
388245-8824596.72196.86
489603-8960398.21098.35
589841-8984198.47198.62
692189-92189101.044101.20
15min192524-92524101.41199.921.16101.72100.231.17
289847-8984798.47798.78
390161-9016198.82199.12
491286-91286100.054100.36
591011-9101199.753100.07
692134-92134100.984101.31
20min192233-92233101.09299.691.69101.57100.161.69
289193-8919397.76098.23
388857-8885797.39297.85
491359-91359100.134100.61
592226-92226101.085101.56
691840-91840100.662101.16
30min196090-96090105.320100.442.55105.97101.082.54
289440-8944098.03198.66
390077-9007798.72999.35
491360-91360100.136100.77
591401-91401100.181100.83
691473-91473100.259100.92
45min189707-8970798.32499.011.0799.1599.821.06
288947-8894797.49198.29
390237-9023798.90599.69
491140-9114099.894100.70
591607-91607100.406101.22
690343-9034399.02199.85
极限191848-91848100.67099.521.48101.66100.491.48
288335-8833596.82097.78
390240-9024098.90899.86
491308-91308100.079101.05
591212-9121299.973100.96
691828-91828100.649101.64
富马酸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%
113.941051951051121050381049881049691050600.09
213.961050781051361051070.04
单位质量响应值RSD%判断
7536.597529.150.07数据可信
长期18月-供试品溶液-2022110211批-氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171507-7150761.54561.877.6461.5461.877.64
271985-7198561.95661.96
366967-6696757.63757.64
468672-6867259.10559.10
569752-6975260.03460.03
682434-8243470.95070.95
10min185751-8575173.80475.085.8173.9175.185.81
286359-8635974.32874.43
385347-8534773.45773.55
486322-8632274.29674.39
582454-8245470.96771.07
697135-9713583.60283.72
15min193185-9318580.20381.204.5280.4381.424.52
293395-9339580.38380.61
393825-9382580.75480.97
494836-9483681.62481.85
588852-8885276.47376.69
6101938-10193887.73687.99
20min198034-9803484.37685.063.8984.7485.423.89
298006-9800684.35284.71
398946-9894685.16185.51
4100089-10008986.14586.50
593006-9300680.04980.39
6104891-10489190.27890.68
30min1107197-10719792.26389.992.8892.7690.502.88
2104252-10425289.72890.23
3105253-10525390.58991.08
4105095-10509590.45390.96
598830-9883085.06185.54
6106710-10671091.84392.40
45min1104771-10477190.17591.011.5690.8391.671.57
2105896-10589691.14391.79
3106101-10610191.31991.97
4107473-10747392.50093.15
5103032-10303288.67889.30
6107184-10718492.25192.96
极限1106224-10622491.42591.692.0692.2392.492.07
2105378-10537890.69791.50
3107927-10792792.89193.69
4106438-10643891.60992.42
5103392-10339288.98889.76
6109801-10980194.50495.36
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