替米沙坦左氨氯地平片项目信息
介质体积(ml)500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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.612683926847267602673226761267880.20
214.432688426798268410.23
单位质量响应值RSD%判断
1833.541860.081.02数据可信
供试品溶液-8145822批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min116261-1626161.77357.118.5961.7757.118.59
216182-1618261.47261.47
315317-1531758.18658.19
413449-1344951.09051.09
515578-1557859.17859.18
613416-1341650.96550.96
10min120642-2064278.41574.828.2179.0375.398.21
221472-2147281.56882.18
319840-1984075.36875.95
417449-1744966.28666.80
520756-2075678.84879.44
618014-1801468.43268.94
15min122188-2218884.28880.737.5985.6982.057.60
223112-2311287.79889.23
321379-2137981.21582.55
419331-1933173.43574.61
522241-2224184.48985.87
619258-1925873.15874.35
20min122516-2251685.53483.195.7887.7885.325.83
223064-2306487.61689.92
322466-2246685.34487.49
420697-2069778.62480.53
522713-2271386.28288.51
619941-1994175.75277.68
30min123632-2363289.77487.685.1592.8790.645.22
224353-2435392.51395.70
323466-2346689.14392.14
421904-2190483.20985.90
523799-2379990.40893.50
621326-2132681.01483.70
45min124308-2430892.34291.142.1996.3494.982.35
224351-2435192.50596.61
324548-2454893.25397.15
423238-2323888.27791.80
524036-2403691.30895.30
623477-2347789.18592.68
60min124555-2455593.28092.801.1698.2097.551.25
224309-2430992.34597.38
324510-2451093.10997.93
424612-2461293.49697.91
524679-2467993.75198.66
623912-2391290.83795.22
90min123296-2329688.49791.093.9694.3596.773.57
223858-2385890.63296.59
322580-2258085.77791.53
425247-2524795.909101.25
524507-2450793.09898.94
624388-2438892.64597.94
120min1-0.0000.00-6.746.584.02
2-0.0006.86
3-0.0006.61
4-0.0006.30
5-0.0006.77
6-0.0006.22
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1-0.0000.00-6.746.584.02
2-0.0006.86
3-0.0006.61
4-0.0006.30
5-0.0006.77
6-0.0006.22
替米沙坦左氨氯地平片项目信息
介质体积(ml)500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10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.612675926861267372672626615267400.33
214.432649826555265260.16
单位质量响应值RSD%判断
1830.251838.250.31数据可信
供试品溶液-8145822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%
5min17786-778629.77931.088.9129.7831.088.91
28028-802830.70430.70
38617-861732.95732.96
49331-933135.68835.69
57548-754828.86828.87
67444-744428.47128.47
10min113001-1300149.72449.567.3750.0249.877.36
213084-1308450.04250.35
314436-1443655.21355.54
413238-1323850.63150.99
512449-1244947.61347.90
611541-1154144.14044.42
15min115173-1517358.03157.165.2458.8357.965.24
215671-1567159.93660.74
314676-1467656.13057.01
415869-1586960.69361.56
514504-1450455.47356.24
613776-1377652.68853.41
20min116011-1601161.23660.166.4262.6161.546.37
216701-1670163.87565.28
316858-1685864.47665.92
415405-1540558.91960.39
515247-1524758.31459.63
614163-1416354.16855.42
30min118347-1834770.17168.484.9372.1670.464.93
218548-1854870.93972.99
318900-1890072.28674.37
417955-1795568.67170.73
516965-1696564.88566.79
616721-1672163.95265.75
45min119216-1921673.49474.261.6376.1876.921.68
219651-1965175.15877.91
319937-1993776.25279.06
419137-1913773.19275.94
519359-1935974.04176.59
619195-1919573.41475.85
60min120088-2008876.82977.901.1280.2581.301.21
220468-2046878.28381.79
320595-2059578.76982.34
420590-2059078.74982.23
520356-2035677.85481.15
620107-2010776.90280.07
90min120574-2057478.68881.162.1082.8885.352.03
221311-2131181.50785.80
321791-2179183.34387.70
421203-2120381.09485.36
520880-2088079.85983.93
621568-2156882.49086.43
120min121244-2124481.25181.812.7486.2386.802.70
221738-2173883.14088.24
322351-2235185.48590.68
420707-2070779.19784.27
521328-2132881.57286.44
620966-2096680.18784.95
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限123200-2320088.73289.452.6394.5295.262.38
223352-2335289.31395.25
323384-2338489.43595.48
422934-2293487.71493.58
522890-2289087.54693.23
624566-2456693.95699.52
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