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%
111.067496847506067502577487477496927497970.10
211.077500407501377500880.01
单位质量响应值RSD%判断
67793.5867758.630.04数据可信
供试品溶液-2024100621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%
5min1330599-33059943.90044.351.6943.9044.351.70
2332801-33280144.19344.19
3340003-34000345.14945.15
4327337-32733743.46743.47
5331533-33153344.02444.02
6341725-34172545.37845.38
10min1602374-60237479.98977.571.9280.2377.821.91
2587582-58758278.02578.27
3577184-57718476.64476.90
4571686-57168675.91476.16
5576953-57695376.61476.86
6589056-58905678.22178.47
15min1697697-69769792.64792.003.6893.3492.673.66
2658149-65814987.39688.07
3673448-67344889.42790.10
4689778-68977891.59692.26
5730638-73063897.02297.69
6707085-70708593.89494.58
20min1749425-74942599.51696.394.80100.7297.584.75
2661890-66189087.89289.06
3733367-73336797.38498.56
4721735-72173595.83997.01
5726563-72656396.48097.69
6762314-762314101.228102.44
30min1709964-70996494.27697.053.4796.0398.783.40
2758415-758415100.710102.36
3694369-69436992.20593.92
4726194-72619496.43198.14
5753980-753980100.121101.87
6742234-74223498.561100.33
45min1744383-74438398.84798.202.15101.13100.462.13
2742318-74231898.573100.78
3707507-70750793.95096.18
4747323-74732399.237101.48
5745773-74577399.031101.33
6749749-74974999.559101.88
60min1735188-73518897.62699.332.03100.45102.131.96
2769270-769270102.151104.91
3737770-73777097.969100.72
4754436-754436100.182102.97
5731975-73197597.199100.05
6759319-759319100.830103.70
极限1740998-74099898.39799.261.74101.77102.621.71
2758335-758335100.699104.03
3724040-72404096.14599.44
4755952-755952100.383103.73
5750706-75070699.686103.08
6754836-754836100.235103.67
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%
111.067489437483777481077479727479017482600.06
211.077483727463087473400.20
单位质量响应值RSD%判断
67654.6167510.390.16数据可信
供试品溶液-2024100621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%
5min1342464-34246445.60645.392.5445.6145.392.54
2337979-33797945.00945.01
3336822-33682244.85544.85
4328316-32831643.72243.72
5345998-34599846.07746.08
6353545-35354547.08247.08
10min1587212-58721278.19977.601.1378.4577.851.13
2576504-57650476.77377.02
3586260-58626078.07378.32
4573612-57361276.38876.63
5582201-58220177.53277.79
6590451-59045178.63178.89
15min1704801-70480193.85993.182.3594.5593.862.34
2678814-67881490.39891.07
3695376-69537692.60493.29
4691613-69161392.10392.77
5699689-69968993.17893.86
6727959-72795996.94397.64
20min1750301-75030199.91897.572.15101.1398.782.14
2705702-70570293.97995.16
3736416-73641698.06999.27
4726864-72686496.79797.98
5732110-73211097.49698.70
6744811-74481199.187100.42
30min1748458-74845899.67398.930.77101.44100.670.78
2739902-73990298.533100.23
3734392-73439297.80099.54
4743171-74317198.969100.69
5741338-74133898.725100.47
6749843-74984399.857101.65
45min1753502-753502100.34498.691.68102.66100.981.66
2734139-73413997.766100.01
3744935-74493599.204101.49
4719332-71933295.79498.06
5746089-74608999.357101.65
6748369-74836999.661102.00
60min1734168-73416897.77098.231.25100.65101.071.23
2735620-73562097.963100.75
3724842-72484296.52899.36
4743360-74336098.994101.79
5735873-73587397.997100.84
6751914-751914100.133103.03
极限1747356-74735699.52698.701.37102.94102.091.36
2736293-73629398.053101.39
3733380-73338097.665101.04
4727508-72750896.883100.23
5750549-75054999.951103.34
6751857-751857100.125103.58
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