氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.451540837154115415435741543960154544115429930.13
211.351538615153658715376010.10
单位质量响应值RSD%判断
134759.21135471.450.38数据可信
长期24月-供试品溶液-X0734批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1224565-22456515.35214.765.3115.3514.765.30
2201762-20176213.79313.79
3231592-23159215.83215.83
4206183-20618314.09514.10
5220078-22007815.04515.04
6211029-21102914.42614.43
480min1397123-39712327.14826.333.6127.1726.353.61
2381642-38164226.09026.11
3395841-39584127.06027.08
4367749-36774925.14025.16
5398129-39812927.21727.24
6370212-37021225.30825.33
720min1535624-53562436.61635.743.3136.6835.803.31
2515994-51599435.27435.33
3536638-53663836.68636.75
4496367-49636733.93333.99
5539794-53979436.90136.96
6512574-51257435.04135.10
1440min1944606-94460664.57562.795.3164.6962.905.30
2836326-83632657.17357.29
3964068-96406865.90666.02
4908453-90845362.10462.21
5960706-96070665.67665.79
6896470-89647061.28461.40
极限1995846-99584668.07865.834.8368.2966.044.82
2875347-87534759.84060.04
3985370-98537067.36267.58
4958175-95817565.50365.71
51001591-100159168.47168.69
6961236-96123665.71265.92
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.451533179153552615374981537451154102015369350.19
211.351529517152776815286420.09
单位质量响应值RSD%判断
134230.13134682.110.24数据可信
长期24月-供试品溶液-X0734批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1217354-21735414.93214.759.2214.9314.769.21
2179140-17914012.30612.31
3212178-21217814.57614.58
4234118-23411816.08316.08
5232119-23211915.94615.95
6213653-21365314.67714.68
480min1412321-41232128.32526.756.2728.3526.776.27
2347107-34710723.84523.86
3396417-39641727.23327.25
4402251-40225127.63327.66
5403888-40388827.74627.77
6374161-37416125.70425.73
720min1581375-58137539.93937.055.5340.0037.115.53
2500735-50073534.39934.45
3538276-53827636.97837.04
4535131-53513136.76236.83
5564092-56409238.75138.82
6515925-51592535.44235.50
1440min1999842-99984268.68665.676.4868.8165.786.47
2990642-99064268.05468.16
31003249-100324968.92069.04
4977214-97721467.13267.25
5917204-91720463.00963.13
6847185-84718558.19958.31
极限11039057-103905771.38068.135.9771.6168.345.96
21050133-105013372.14172.35
31005437-100543769.07069.29
41008359-100835969.27169.49
5955942-95594265.67065.89
6891298-89129861.22961.43
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