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%
110.991437002142928914291351435065143763114336240.29
211.211457516146382914606720.31
单位质量响应值RSD%判断
130448.04130300.800.08数据可信
供试品溶液-2024041821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%
30min1181656-18165612.35410.5019.2912.3510.5019.28
2174630-17463011.87611.88
398928-989286.7286.73
4166067-16606711.29411.29
5146969-1469699.99510.00
6158135-15813510.75410.75
120min1665216-66521645.24041.2015.8645.2641.2215.86
2696361-69636147.35847.38
3428565-42856529.14629.16
4653764-65376444.46144.48
5580534-58053439.48139.50
6610104-61010441.49241.51
240min11238634-123863484.23778.7913.0584.3278.8713.06
21285854-128585487.44887.54
3869808-86980859.15459.21
41245618-124561884.71284.80
51137219-113721977.34077.41
61173953-117395379.83879.92
360min11495143-1495143101.68198.997.21101.8999.187.22
21526890-1526890103.840104.06
31244611-124461184.64384.79
41507481-1507481102.520102.73
51482056-1482056100.791100.98
61476838-1476838100.436100.63
480min11463913-146391399.557101.571.4299.92101.911.42
21527697-1527697103.895104.27
31492045-1492045101.471101.74
41502916-1502916102.210102.57
51487037-1487037101.130101.47
61487165-1487165101.139101.49
极限11485252-1485252101.009101.781.38101.52102.281.38
21528435-1528435103.945104.48
31506050-1506050102.423102.84
41506117-1506117102.428102.95
51475241-1475241100.328100.82
61478538-1478538100.552101.05
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%
110.991440103143798714364301440930143634514383590.15
211.211475842148199414789180.30
单位质量响应值RSD%判断
130878.89131928.460.57数据可信
供试品溶液-X0734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%
30min1100833-1008336.8048.5823.276.808.5723.27
2136518-1365189.2129.21
396193-961936.4916.49
4107577-1075777.2597.26
5160531-16053110.83210.83
6160846-16084610.85310.85
120min1464154-46415431.31939.6020.3531.3339.6220.35
2604732-60473240.80540.82
3451972-45197230.49730.51
4555806-55580637.50437.51
5721163-72116348.66148.68
6723687-72368748.83248.85
240min1959755-95975564.76074.9610.9364.8275.0410.94
21196950-119695080.76580.84
3952409-95240964.26564.32
41153249-115324977.81777.88
51196453-119645380.73280.82
61206986-120698681.44381.53
360min11356323-135632391.51996.755.3791.6796.935.38
21484574-1484574100.173100.37
31319497-131949789.03489.19
41494066-1494066100.814101.00
51497218-1497218101.026101.24
61451065-145106597.91298.12
480min11512398-1512398102.051100.531.27102.34100.861.26
21487166-1487166100.348100.69
31473903-147390399.45399.74
41498833-1498833101.135101.47
51504227-1504227101.499101.86
61463042-146304298.72099.08
极限11505967-1505967101.617100.291.32102.06100.771.31
21486095-1486095100.276100.77
31478229-147822999.745100.18
41499629-1499629101.189101.68
51495873-1495873100.936101.45
61451680-145168097.95498.46
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