坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.311937991937651934541937011934991936440.09
2 16.231941681942571942120.04
单位质量响应值RSD%判断
11872.7211966.240.56数据可信
供试品溶液-24111402批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123258-2325811.01512.6413.1911.0212.6413.19
222953-2295310.87110.87
331719-3171915.02315.02
428038-2803813.27913.28
529197-2919713.82813.83
625005-2500511.84311.84
10min163388-6338830.02235.3510.5330.1435.4910.54
267421-6742131.93232.05
384721-8472140.12640.29
478459-7845937.16037.31
578186-7818637.03037.18
675650-7565035.82935.96
15min1107636-10763650.97957.056.6351.4357.586.67
2114970-11497054.45254.93
3130027-13002761.58362.20
4123005-12300558.25858.82
5125409-12540959.39659.96
6121648-12164857.61558.14
20min1144414-14441468.39772.683.7869.4273.853.85
2148799-14879970.47471.55
3159858-15985875.71277.01
4155896-15589673.83575.04
5157518-15751874.60475.83
6154306-15430673.08274.25
30min1184416-18441687.34389.361.6989.1391.341.79
2185130-18513087.68189.54
3190781-19078190.35892.50
4190967-19096790.44692.47
5191888-19188890.88292.94
6188882-18888289.45891.44
45min1204981-20498197.08398.080.9499.84101.041.02
2205135-20513597.15699.99
3206638-20663897.868101.01
4208226-20822698.620101.65
5210089-21008999.502102.57
6207409-20740998.233101.21
60min1210679-21067999.782100.540.86103.61104.600.91
2210652-21065299.769103.69
3210779-21077999.829104.06
4214055-214055101.381105.51
5214621-214621101.649105.82
6212881-212881100.825104.89
极限1211306-211306100.079100.830.83105.02106.000.88
2211676-211676100.254105.28
3211168-211168100.013105.35
4214496-214496101.590106.84
5215287-215287101.964107.26
6213416-213416101.078106.27
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.311936981940201939761940001935391938470.12
2 16.231948441951011949720.10
单位质量响应值RSD%判断
11885.1612013.060.76数据可信
供试品溶液-24111401批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112217-122175.7727.2317.965.777.2317.95
216692-166927.8867.89
312101-121015.7175.72
414631-146316.9126.91
518234-182348.6158.61
617947-179478.4798.48
10min145756-4575621.61723.6214.6421.6823.7014.65
254305-5430525.65625.74
338645-3864518.25818.32
447458-4745822.42222.50
556652-5665226.76526.86
657190-5719027.01927.11
15min185937-8593740.60142.3611.0440.9142.7011.07
295690-9569045.20945.58
373019-7301934.49834.76
486692-8669240.95841.28
596965-9696545.81146.20
699653-9965347.08147.48
20min1125511-12551159.29859.479.1060.0560.289.14
2136300-13630064.39565.27
3105191-10519149.69850.35
4122665-12266557.95358.73
5130265-13026561.54462.45
6135342-13534263.94264.86
30min1175927-17592783.11781.164.8184.5382.644.89
2178574-17857484.36785.96
3155631-15563173.52874.73
4171619-17161981.08282.51
5173657-17365782.04483.63
6175342-17534282.84184.47
45min1201963-20196395.41894.591.8397.7696.961.94
2205634-20563497.15299.68
3195757-19575792.48694.50
4196542-19654292.85795.18
5201029-20102994.97697.47
6200278-20027894.62297.17
60min1209587-20958799.02098.001.58102.42101.431.58
2211844-211844100.086103.69
3207820-20782098.185101.23
4202853-20285395.83899.20
5204600-20460096.664100.22
6207909-20790998.227101.83
极限1209772-20977299.10797.991.50103.61102.501.49
2211905-211905100.115104.83
3207207-20720797.895102.03
4203641-20364196.210100.63
5207275-20727597.927102.55
6204622-20462296.674101.37
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