坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.067713477012775407703076973771380.31
216.247722077309772640.09
单位质量响应值RSD%判断
4803.114757.640.68数据可信
供试品溶液-2025022821批-tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115340-1534018.01524.9517.2818.0124.9517.28
225651-2565130.12330.12
322614-2261426.55726.56
419043-1904322.36322.36
521090-2109024.76724.77
623759-2375927.90227.90
10min138511-3851145.22658.7713.8845.2658.8213.88
257677-5767767.73467.78
352556-5255661.72061.76
447282-4728255.52655.56
548436-4843656.88156.92
655828-5582865.56265.61
15min157322-5732267.31779.718.0767.4279.858.09
272553-7255385.20385.37
368613-6861380.57680.72
469231-6923181.30281.43
567857-6785779.68879.82
671665-7166584.16084.32
20min170968-7096883.34288.483.2783.5688.753.29
278048-7804891.65691.96
374632-7463287.64587.93
476829-7682990.22590.49
575162-7516288.26788.54
676407-7640789.72990.03
30min177866-7786691.44392.401.1891.8092.821.19
279523-7952393.38993.85
377966-7796691.56091.99
479995-7999593.94394.36
578865-7886592.61693.03
677887-7788791.46791.91
45min178657-7865792.37293.391.0192.8893.961.02
279898-7989893.82994.44
378679-7867992.39792.98
480732-8073294.80895.38
579839-7983993.76094.33
679328-7932893.16093.76
60min178546-7854692.24193.291.2792.9094.021.28
279334-7933493.16793.94
378099-7809991.71692.45
480736-8073694.81395.54
579622-7962293.50594.23
680299-8029994.30095.05
极限178767-7876792.50193.151.1593.3294.041.14
279085-7908592.87493.80
378166-7816691.79592.68
480840-8084094.93595.82
579546-7954693.41694.30
679526-7952693.39294.30
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.067727877463774867729077386773810.13
216.247734777260773040.08
单位质量响应值RSD%判断
4818.244760.100.86数据可信
供试品溶液-2025022821批-tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117096-1709620.04022.1515.7720.0422.1515.77
223306-2330627.32027.32
321749-2174925.49525.49
417046-1704619.98219.98
518418-1841821.59021.59
615752-1575218.46518.46
10min142611-4261149.94952.777.1649.9852.817.17
249667-4966758.22158.27
347226-4722655.35955.40
442880-4288050.26550.30
546358-4635854.34254.38
641374-4137448.49948.53
15min163055-6305573.91476.985.1774.0377.115.17
270190-7019082.27882.42
367945-6794579.64679.78
462977-6297773.82373.94
567825-6782579.50679.63
662045-6204572.73072.84
20min175303-7530388.27289.441.7688.5189.691.77
277766-7776691.15991.44
376847-7684790.08290.35
474296-7429687.09187.33
577506-7750690.85491.11
676068-7606889.16889.40
30min181235-8123595.22594.861.0295.6195.261.02
281003-8100394.95395.38
380799-8079994.71495.13
479425-7942593.10393.49
581887-8188795.98996.40
681196-8119695.17995.56
45min182374-8237496.56095.940.6797.1196.500.67
281729-8172995.80496.39
381873-8187395.97396.55
480988-8098894.93695.48
582487-8248796.69397.26
681624-8162495.68196.22
60min182767-8276797.02196.131.0097.7396.851.00
282113-8211396.25497.00
381914-8191496.02196.76
480573-8057394.44995.15
582802-8280297.06297.79
681876-8187695.97796.68
极限182776-8277697.03296.340.7797.9097.220.77
282126-8212696.27097.18
382161-8216196.31197.21
481071-8107195.03395.89
582785-8278597.04297.94
682192-8219296.34797.21
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.067823577907780507839878544782270.33
216.247922079416793180.18
单位质量响应值RSD%判断
4870.924884.110.20数据可信
供试品溶液-2025022821批-tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120919-2091924.07723.034.9824.0823.024.98
218847-1884721.69221.69
321100-2110024.28524.28
419502-1950222.44622.45
519040-1904021.91421.91
620625-2062523.73823.74
10min153475-5347561.54756.974.1461.5957.014.14
248891-4889156.27156.31
349255-4925556.69056.73
449326-4932656.77256.81
547589-4758954.77254.81
648468-4846855.78455.82
15min170632-7063281.29478.441.9381.4478.571.93
267823-6782378.06178.19
366966-6696677.07477.21
468183-6818378.47578.61
567192-6719277.33477.46
668101-6810178.38178.51
20min177051-7705188.68287.031.7288.9687.301.72
275233-7523386.58986.85
373574-7357484.68084.94
477005-7700588.62988.89
575275-7527586.63786.89
675581-7558186.99087.25
30min181245-8124593.50992.131.5093.9392.541.50
279800-7980091.84692.25
378054-7805489.83690.24
481340-8134093.61894.03
580003-8000392.07992.48
679836-7983691.88792.30
45min182200-8220094.60893.331.7895.1993.891.77
280947-8094793.16693.72
378686-7868690.56391.12
482876-8287695.38695.95
581073-8107393.31193.87
680756-8075692.94693.51
60min182162-8216294.56493.811.4195.3094.531.41
281411-8141193.70094.41
379313-7931391.28591.99
482449-8244994.89495.62
581521-8152193.82694.54
682187-8218794.59395.31
极限182376-8237694.81093.581.6595.7194.461.64
281924-8192494.29095.16
379231-7923191.19192.05
482840-8284095.34496.23
580988-8098893.21394.08
680509-8050992.66293.54
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