阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972894992901622907162897692899032900100.16
211.002913342896742905040.41
单位质量响应值RSD%判断
26436.6526409.450.08数据可信
供试品溶液-25112701批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116860-168605.7253.5249.675.733.5249.66
27629-76292.5912.59
35582-55821.8961.90
45144-51441.7471.75
516039-160395.4475.45
610878-108783.6943.69
10min185131-8513128.91023.2623.1328.9423.2823.14
242313-4231314.36914.38
368699-6869923.32923.34
459530-5953020.21620.23
582346-8234627.96427.99
672918-7291824.76224.78
15min1141153-14115347.93443.888.2448.1344.038.30
2113016-11301638.37938.47
3131521-13152144.66344.80
4120492-12049240.91841.04
5137883-13788346.82447.01
6131302-13130244.58944.75
20min1166975-16697556.70353.764.7557.1654.154.82
2150115-15011550.97851.28
3157717-15771753.55953.95
4149107-14910750.63550.98
5165403-16540356.16956.61
6160552-16055254.52254.93
30min1190846-19084664.80963.812.9565.5864.503.01
2183182-18318262.20762.80
3188683-18868364.07564.76
4179212-17921260.85961.49
5192801-19280165.47366.23
6192639-19263965.41866.13
45min1210672-21067271.54270.392.2372.6871.432.27
2206005-20600569.95770.89
3209249-20924971.05972.10
4198831-19883167.52168.49
5207357-20735770.41671.54
6211484-21148471.81872.89
60min1218322-21832274.14073.502.8175.6774.932.83
2212642-21264272.21173.54
3217657-21765773.91475.35
4207342-20734270.41171.76
5217111-21711173.72975.24
6225470-22547076.56778.04
极限1239288-23928881.26080.661.9083.2082.501.93
2237907-23790780.79182.52
3237919-23791980.79582.64
4228839-22883977.71179.45
5239250-23925081.24783.17
6241916-24191682.15284.05
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.037321673066726107339673255731090.42
214.957322073145731820.08
单位质量响应值RSD%判断
4864.204895.120.45数据可信
供试品溶液-25112701批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118740-1874024.89920.3564.2224.9020.3564.22
2-0.0000.00
316600-1660022.05622.06
413315-1331517.69117.69
512889-1288917.12517.13
630341-3034140.31340.31
10min157510-5751076.41270.985.8376.5571.105.89
250163-5016366.65066.65
352739-5273970.07370.20
450189-5018966.68566.78
553340-5334070.87170.97
656597-5659775.19975.42
15min167935-6793590.26386.412.7390.8386.922.79
263594-6359484.49684.87
363902-6390284.90585.42
463601-6360184.50584.97
564792-6479286.08786.58
666373-6637388.18888.83
20min170059-7005993.08690.552.0294.1591.542.06
267518-6751889.70990.55
366323-6632388.12289.11
467200-6720089.28790.23
568955-6895591.61992.59
668845-6884591.47392.60
30min171455-7145594.94093.301.2796.5294.801.33
269463-6946392.29493.63
369072-6907291.77493.25
469974-6997492.97394.41
570654-7065493.87695.35
670725-7072593.97095.61
45min171181-7118194.57693.511.0296.6995.521.00
271085-7108594.44996.30
369498-6949892.34094.32
470622-7062293.83495.78
569632-6963292.51894.52
670271-7027193.36795.53
60min171308-7130894.74593.621.1697.3896.151.18
270572-7057293.76796.14
368956-6895691.62094.12
470274-7027493.37195.84
570785-7078594.05096.56
670888-7088894.18796.87
极限169921-6992192.90293.171.0596.0696.220.96
270949-7094994.26897.16
369009-6900991.69094.70
470304-7030493.41196.40
570832-7083294.11397.15
669720-6972092.63595.84
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