替米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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.067489107459067479757486807466507476240.18
211.077500177496637498400.04
单位质量响应值RSD%判断
67597.1167736.220.15数据可信
供试品溶液-2024100621批-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%
5min1195111-19511125.95127.0510.0825.9527.0510.08
2213946-21394628.45628.46
3191473-19147325.46725.47
4191151-19115125.42425.42
5187866-18786624.98724.99
6240621-24062132.00432.00
10min1397962-39796252.93151.457.7953.0851.607.80
2403088-40308853.61353.77
3375739-37573949.97550.12
4346550-34655046.09346.23
5366393-36639348.73248.87
6431398-43139857.37857.56
15min1507827-50782767.54464.807.2967.9865.237.29
2512198-51219868.12568.58
3475504-47550463.24463.66
4433779-43377957.69558.09
5464772-46477261.81762.23
6528999-52899970.36070.86
20min1563556-56355674.95671.735.0475.7772.525.06
2536723-53672371.38772.22
3520944-52094469.28870.06
4502520-50252066.83867.56
5535286-53528671.19671.95
6576566-57656676.68677.57
30min1647708-64770886.14879.685.0987.3880.885.05
2624488-62448883.06084.29
3593643-59364378.95880.11
4572002-57200276.07977.17
5581251-58125177.30978.46
6575498-57549876.54477.86
45min1638008-63800884.85882.192.7986.5783.832.83
2635284-63528484.49686.19
3598933-59893379.66181.26
4605907-60590780.58982.10
5603623-60362380.28581.86
6626048-62604883.26885.01
60min1642188-64218885.41483.213.2487.5985.303.24
2637145-63714584.74486.91
3590004-59000478.47480.51
4612740-61274081.49883.46
5634136-63413684.34386.37
6637434-63743484.78286.98
极限1609834-60983481.11185.152.5683.7787.702.45
2641796-64179685.36287.99
3638185-63818584.88287.35
4642528-64252885.45987.87
5653723-65372386.94889.44
6654956-65495687.11289.78
替米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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.067480397472187470857489597469607476520.12
211.077466387470227468300.04
单位质量响应值RSD%判断
67599.6467464.320.15数据可信
供试品溶液-2024100621批-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%
5min1221463-22146329.51428.626.9129.5128.626.91
2225094-22509429.99830.00
3190217-19021725.35025.35
4231911-23191130.90730.91
5208824-20882427.83027.83
6210898-21089828.10628.11
10min1406208-40620854.13551.5110.9454.3051.6710.92
2404147-40414753.86154.03
3357362-35736247.62647.77
4432762-43276257.67457.85
5402662-40266253.66353.82
6315921-31592142.10342.26
15min1530508-53050870.70164.288.0671.1764.738.03
2519117-51911769.18369.65
3446785-44678559.54359.95
4485624-48562464.71965.21
5431420-43142057.49557.95
6480727-48072764.06764.46
20min1545470-54547072.69571.883.2173.5572.683.23
2564096-56409675.17776.03
3520441-52044169.35970.10
4541714-54171472.19473.05
5545744-54574472.73173.50
6518448-51844869.09469.84
30min1571159-57115976.11976.611.6977.3877.811.59
2562920-56292075.02176.29
3576977-57697776.89478.02
4567231-56723175.59576.85
5581562-58156277.50578.68
6589098-58909878.50979.64
45min1598866-59886679.81182.184.1481.5083.814.05
2608422-60842281.08582.77
3606066-60606680.77182.32
4622238-62223882.92684.60
5665643-66564388.71090.32
6598806-59880679.80381.37
60min1676587-67658790.16983.885.3392.3085.965.24
2621778-62177882.86585.00
3620222-62022282.65784.65
4616073-61607382.10484.24
5658978-65897887.82289.92
6582525-58252577.63379.64
极限1682372-68237290.94088.112.5293.5790.662.51
2651077-65107786.76989.36
3663992-66399288.49090.95
4673349-67334989.73792.33
5660866-66086688.07490.66
6635096-63509684.63987.08
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