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%
111.137428847430267392427387097380527403830.33
211.167435217435867435540.01
单位质量响应值RSD%判断
66521.3866626.700.12数据可信
供试品溶液-2023052121批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min188884-8888412.01612.466.5912.0212.466.57
294558-9455812.78312.78
399153-9915313.40413.40
496134-9613412.99613.00
582007-8200711.08611.09
692231-9223112.46912.47
10min1165222-16522222.33623.347.5722.4023.407.57
2184852-18485224.99025.06
3184141-18414124.89424.97
4178695-17869524.15724.23
5150736-15073620.37820.44
6172054-17205423.26023.33
15min1234388-23438831.68633.147.2631.8833.347.26
2272188-27218836.79737.01
3249081-24908133.67333.89
4251021-25102133.93534.14
5219018-21901829.60929.78
6244928-24492833.11133.31
20min1300527-30052740.62841.816.4940.9942.196.49
2336727-33672745.52145.94
3330389-33038944.66545.06
4305002-30500241.23341.63
5284899-28489938.51538.85
6298126-29812640.30340.69
30min1431351-43135158.31358.387.2058.9158.997.17
2482366-48236665.21065.88
3452526-45252661.17661.82
4397781-39778153.77554.40
5411711-41171155.65856.21
6415203-41520356.13056.74
45min1535035-53503572.33072.836.1173.2573.776.06
2566851-56685176.63177.66
3562131-56213175.99376.98
4477473-47747364.54965.47
5555711-55571175.12575.99
6535338-53533872.37173.29
60min1556529-55652975.23678.876.4276.5580.216.36
2620346-62034683.86385.32
3612940-61294082.86284.27
4531096-53109671.79873.08
5614440-61444083.06584.34
6565110-56511076.39677.72
90min1693952-69395293.81492.222.9495.5594.002.91
2688550-68855093.08495.00
3693331-69333193.73095.60
4677465-67746591.58593.27
5696151-69615194.11195.85
6643643-64364387.01388.76
120min1685430-68543092.66295.834.8894.9298.124.76
2671823-67182390.82293.26
3754499-754499101.999104.39
4694718-69471893.91796.11
5697271-69727194.26396.53
6749304-749304101.297103.52
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1707091-70709195.59099.993.4598.36102.823.37
2744969-744969100.711103.65
3755288-755288102.106105.06
4777910-777910105.164107.87
5719139-71913997.219100.01
6733541-73354199.166101.96
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%
111.137679307694587645287616487610997649330.49
211.167438897499667469280.58
单位质量响应值RSD%判断
68727.1366929.031.88数据可信
供试品溶液-2023052121批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min197867-9786712.98812.206.2512.9912.206.24
295703-9570312.70112.70
392387-9238712.26112.26
481439-8143910.80810.81
593721-9372112.43812.44
690621-9062112.02612.03
10min1193294-19329425.65222.936.8825.7223.006.88
2174500-17450023.15823.23
3168048-16804822.30222.37
4156679-15667920.79320.85
5172265-17226522.86222.93
6172028-17202822.83022.90
15min1251011-25101133.31231.854.8933.5332.044.90
2245404-24540432.56832.77
3247143-24714332.79932.99
4218426-21842628.98829.16
5241936-24193632.10832.30
6235950-23595031.31331.51
20min1328753-32875343.62940.195.0744.0340.565.06
2289818-28981838.46238.84
3293962-29396239.01239.39
4289298-28929838.39338.73
5311264-31126441.30841.68
6303791-30379140.31740.68
30min1434622-43462257.67953.544.3358.3254.144.33
2396176-39617652.57753.17
3391757-39175751.99152.58
4385310-38531051.13551.69
5408830-40883054.25754.86
6403957-40395753.61054.20
45min1488026-48802664.76764.942.0065.7365.841.99
2507074-50707467.29568.18
3484478-48447864.29665.18
4477836-47783663.41464.25
5490490-49049065.09466.00
6488264-48826464.79865.69
60min1594850-59485078.94477.333.7480.2778.583.69
2590381-59038178.35079.61
3614243-61424381.51782.75
4575965-57596576.43777.62
5567954-56795475.37476.64
6552563-55256373.33274.58
90min1698289-69828992.67192.541.7394.4394.221.73
2714928-71492894.87996.57
3699446-69944692.82594.51
4678006-67800689.97991.59
5692271-69227191.87293.56
6700919-70091993.02094.68
120min1730680-73068096.97091.844.2999.2594.044.24
2721632-72163295.76997.99
3670659-67065989.00491.21
4654593-65459386.87288.98
5695068-69506892.24494.44
6679423-67942390.16792.34
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1720479-72047995.61693.022.7398.4395.722.69
2709507-70950794.16096.91
3707958-70795893.95496.65
4703612-70361293.37895.97
5699015-69901592.76795.48
6664749-66474988.22090.89
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