替米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100629-202204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%
111.107601617616117600727601677596277603280.10
211.167555417594327574860.37
单位质量响应值RSD%判断
68498.0267875.090.65数据可信
加速6月-供试品溶液-2024070521批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1303334-30333440.03840.873.1840.0440.873.18
2314226-31422641.47641.48
3293081-29308138.68538.68
4317710-31771041.93641.94
5318674-31867442.06342.06
6310841-31084141.02941.03
10min1538881-53888171.12972.321.9271.3572.551.91
2554880-55488073.24173.47
3565636-56563674.66074.88
4546164-54616472.09072.32
5543172-54317271.69571.93
6538815-53881571.12071.35
15min1682095-68209590.03289.631.7690.6590.261.75
2681984-68198490.01890.65
3671299-67129988.60789.24
4694361-69436191.65192.28
5684548-68454890.35690.99
6659959-65995987.11087.73
20min1732863-73286396.73394.881.9597.8596.011.93
2720226-72022695.06596.20
3715163-71516394.39795.52
4733102-73310296.76597.91
5716403-71640394.56195.69
6695357-69535791.78392.89
30min1711534-71153493.91895.581.1395.5797.241.12
2727224-72722495.98997.65
3718818-71881894.87996.53
4733857-73385796.86498.54
5730272-73027296.39198.05
6723192-72319295.45797.07
45min1725421-72542195.75195.401.0697.9397.591.05
2712228-71222894.01096.21
3721739-72173995.26597.44
4733604-73360496.83199.05
5726993-72699395.95898.15
6716722-71672294.60396.75
60min1720061-72006195.04393.903.4197.7596.613.32
2674517-67451789.03291.75
3691919-69191991.32994.03
4742517-74251798.007100.76
5717678-71767894.72997.46
6721704-72170495.26097.93
极限1738167-73816797.43395.741.19100.6798.981.15
2723772-72377295.53398.75
3714607-71460794.32497.53
4719956-71995695.03098.33
5723042-72304295.43798.69
6732698-73269896.71199.91
替米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100629-202204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%
111.107593557587057586277595887582637589080.08
211.167591817582927587360.09
单位质量响应值RSD%判断
68370.0967987.100.40数据可信
加速6月-供试品溶液-2024070521批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1297412-29741239.26139.132.0639.2639.132.06
2299006-29900639.47139.47
3302704-30270439.95939.96
4301486-30148639.79839.80
5288832-28883238.12838.13
6289003-28900338.15138.15
10min1541104-54110471.43069.035.0871.6569.255.07
2547259-54725972.24272.46
3475188-47518862.72862.95
4532690-53269070.31970.54
5510234-51023467.35567.57
6531155-53115570.11670.33
15min1673746-67374688.93983.524.8789.5584.124.85
2644651-64465185.09985.72
3587248-58724877.52178.09
4625121-62512182.52183.13
5612804-61280480.89581.48
6652499-65249986.13586.74
20min1718501-71850194.84791.932.6495.9692.992.62
2673652-67365288.92790.02
3686535-68653590.62891.63
4680868-68086889.88090.95
5708707-70870793.55494.59
6710016-71001693.72794.81
30min1704776-70477693.03692.281.8294.6793.861.80
2709070-70907093.60295.19
3708996-70899693.59395.10
4691265-69126591.25292.82
5676820-67682089.34590.90
6703360-70336092.84994.45
45min1674237-67423789.00489.104.5291.1691.194.39
2671221-67122188.60690.71
3716567-71656794.59296.62
4696274-69627491.91393.99
5664893-66489387.77189.82
6626592-62659282.71584.83
60min1713876-71387694.23791.083.1596.8893.663.10
2703803-70380392.90795.51
3680125-68012589.78192.33
4704906-70490693.05395.64
5655332-65533286.50989.05
6681648-68164889.98392.56
极限1705360-70536093.11392.921.9996.2896.011.92
2689286-68928690.99194.11
3684692-68469290.38493.43
4713923-71392394.24397.35
5719470-71947094.97598.00
6710538-71053893.79696.87
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