阿齐沙坦左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100546-202105 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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.324378144024438924391343846438910.21
211.394394544000439720.09
单位质量响应值RSD%判断
3877.303860.580.31数据可信
供试品溶液-24022501批-左氨氯地平-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%
5min139976-3997683.50585.223.8883.5085.223.88
238615-3861580.66280.66
339649-3964982.82182.82
442205-4220588.16188.16
542140-4214088.02588.02
642199-4219988.14888.15
10min146130-4613096.35993.621.9196.8294.101.90
244028-4402891.96992.42
343750-4375091.38891.85
445152-4515294.31794.81
545007-4500794.01494.50
644849-4484993.68494.17
15min146016-4601696.12193.741.9897.1294.731.98
244240-4424092.41193.37
343607-4360791.08992.06
445584-4558495.21996.23
544663-4466393.29594.31
645132-4513294.27595.28
20min146030-4603096.15193.302.3097.6894.822.28
244213-4421392.35593.83
344033-4403391.97993.45
445883-4588395.84397.39
544226-4422692.38293.91
643610-4361091.09592.63
30min145765-4576595.59793.871.6697.6695.901.67
244240-4424092.41194.40
344006-4400691.92393.91
445557-4555795.16397.24
544613-4461393.19195.23
645439-4543994.91696.96
45min145528-4552895.10294.211.7497.7096.771.71
245600-4560095.25297.75
343938-4393891.78194.28
445660-4566095.37897.98
544272-4427292.47895.04
645614-4561495.28297.85
60min145521-4552195.08792.802.0998.2195.872.06
243878-4387891.65594.68
343943-4394391.79194.80
445439-4543994.91698.05
544575-4457593.11196.19
643190-4319090.21893.31
极限148593-48593101.504100.202.63105.16103.792.56
247448-4744899.113102.65
346309-4630996.733100.25
447718-4771899.677103.34
547688-4768899.614103.21
650053-50053104.554108.15
阿齐沙坦左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%
110.733803333811703810383807493802963807170.11
210.823812663813053812860.01
单位质量响应值RSD%判断
35481.5535239.000.49数据可信
供试品溶液-24022501批-阿齐沙坦-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%
5min1209759-20975953.22952.2823.7653.2352.2823.76
2137199-13719934.81634.82
3157186-15718639.88839.89
4249558-24955863.32863.33
5256513-25651365.09365.09
6225919-22591957.33057.33
10min1324550-32455082.35983.243.4782.6583.533.39
2337668-33766885.68785.88
3346262-34626287.86888.09
4320176-32017681.24981.60
5322260-32226081.77782.14
6317325-31732580.52580.84
15min1328938-32893883.47284.584.0284.2385.343.92
2347741-34774188.24488.91
3352629-35262989.48490.19
4323707-32370782.14582.95
5321443-32144381.57082.39
6325470-32547082.59283.36
20min1330237-33023783.80284.944.1185.0286.164.01
2349088-34908888.58589.75
3354623-35462389.99091.20
4327220-32722083.03684.30
5320792-32079281.40582.67
6326397-32639782.82784.05
30min1330652-33065283.90785.693.9485.5987.383.85
2353651-35365189.74391.40
3355429-35542990.19491.90
4330252-33025283.80685.53
5324726-32472682.40384.12
6331347-33134784.08385.77
45min1333592-33359284.65386.965.0086.8089.134.88
2368999-36899993.63895.79
3358932-35893291.08393.29
4330480-33048083.86386.05
5326993-32699382.97985.16
6337177-33717785.56387.71
60min1334773-33477384.95387.144.3787.5789.794.27
2362966-36296692.10794.78
3362154-36215491.90194.61
4332249-33224984.31286.96
5331369-33136984.08986.73
6336808-33680885.46988.10
极限1371530-37153094.28097.443.3297.37100.583.27
2396969-396969100.736103.92
3402577-402577102.159105.38
4378203-37820395.97499.09
5380145-38014596.46699.57
6374431-37443195.01698.12
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