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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.741404755140763314075901405784140875714069040.12
211.231474029146965914718440.21
单位质量响应值RSD%判断
130996.65131063.580.04数据可信
影响因素10天裸放高湿-供试品溶液-2024022621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min18970289816897596.0745.626.056.075.626.07
28472284569846465.7285.73
38649786578865385.8565.86
48000580144800745.4185.42
58116381238812005.4955.49
67585475607757305.1245.12
120min136549036481236515124.70921.358.7524.7221.368.75
232540632552432546522.02322.03
329158629170129164419.73519.74
431600631655131627821.40221.41
529900729934629917620.24420.25
629498029579429538719.98820.00
240min181681981572581627255.23548.639.6455.2848.679.63
269215769364269290046.88746.93
366083566174566129044.74844.79
479686479736479711453.93953.98
567025767001067013445.34645.38
667463067416667439845.63545.67
480min1151995115197271519839102.84494.447.08102.9794.557.08
212272321226581122690683.02183.13
313879061390230138906893.99594.10
414607351458989145986298.78598.91
513713411370813137107792.77792.88
614077181406434140707695.21395.32
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.741396955139714413970651396819139620513968380.03
211.231469196147033114697640.06
单位质量响应值RSD%判断
130059.40130878.360.45数据可信
影响因素10天裸放光照-供试品溶液-2024022621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min17724477203772245.2485.505.495.255.505.47
27859378669786315.3445.34
38944389591895176.0836.08
48097080974809725.5035.50
58029180339803155.4585.46
67862178642786325.3445.34
120min131169131130531149821.16922.165.7621.1822.175.76
232992932960832976822.41122.42
335559535602835581224.18124.19
431642231663831653021.51121.52
533723833760433742122.93122.94
630518130556030537020.75320.76
240min170759370773770766548.09249.907.1348.1349.947.13
274626774573574600150.69850.74
377043076985677014352.33852.38
471723771777871750848.76148.80
580726280717780722054.85854.90
665722965724565723744.66544.70
480min1149370614943461494026101.533100.200.91101.64100.320.90
2147092914722601471594100.008100.13
314607991461916146135899.31399.44
4148324814914961487372101.080101.19
514702601468396146932899.85499.98
614620721463907146299099.42499.53
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