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%
110.991441763143759914409061438437143806214393530.13
211.211476724147865714776900.10
单位质量响应值RSD%判断
130969.34131818.910.46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%
30min1110256-1102567.4407.973.957.447.973.95
2123089-1230898.3068.31
3115611-1156117.8017.80
4119644-1196448.0748.07
5121734-1217348.2158.21
6118095-1180957.9697.97
120min1446697-44669730.14330.162.0930.1530.172.09
2436151-43615129.43229.44
3452277-45227730.52030.53
4462218-46221831.19131.20
5440115-44011529.69929.71
6443952-44395229.95829.97
240min1982157-98215766.27766.832.3666.3366.882.36
2972587-97258765.63165.69
31024623-102462369.14269.20
41001039-100103967.55167.61
5960088-96008864.78764.84
61001381-100138167.57467.63
360min11473969-147396999.46495.562.9599.6295.722.95
21353591-135359191.34191.50
31443836-144383697.43197.59
41405621-140562194.85295.01
51425760-142576096.21196.37
61394296-139429694.08894.25
480min11507860-1507860101.751102.181.05102.06102.481.05
21498623-1498623101.128101.42
31518172-1518172102.447102.75
41541336-1541336104.010104.31
51500131-1500131101.230101.53
61519233-1519233102.519102.82
极限11506157-1506157101.636102.000.77102.09102.450.76
21496331-1496331100.973101.42
31518079-1518079102.441102.90
41523777-1523777102.825103.28
51502345-1502345101.379101.83
61522679-1522679102.751103.20
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%
110.991438303144010214419841441871144102314406570.11
211.211463447146242014629340.05
单位质量响应值RSD%判断
131087.99130502.590.32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%
30min194082-940826.3786.237.316.386.237.31
281710-817105.5395.54
397721-977216.6246.62
491613-916136.2106.21
599356-993566.7356.74
686708-867085.8785.88
120min1447307-44730730.32330.648.0930.3330.658.08
2392523-39252326.60926.62
3481670-48167032.65232.66
4432077-43207729.29029.30
5492459-49245933.38333.39
6466185-46618531.60231.61
240min11046581-104658170.94770.143.0871.0070.203.08
21001139-100113967.86667.91
31014478-101447868.77168.83
41005595-100559568.16868.22
51072208-107220872.68472.74
61068313-106831372.42072.48
360min11473402-147340299.88198.501.78100.0498.661.78
21421180-142118096.34196.49
31442676-144267697.79897.96
41430670-143067096.98497.14
51463285-146328599.19599.36
61487178-1487178100.815100.98
480min11491684-1491684101.120101.181.90101.43101.491.90
21487447-1487447100.833101.13
31477285-1477285100.144100.45
41494218-1494218101.292101.59
51460289-146028998.99299.31
61544582-1544582104.706105.02
极限11490397-1490397101.033100.841.29101.50101.301.28
21492219-1492219101.156101.60
31464192-146419299.25699.72
41496559-1496559101.451101.90
51467141-146714199.45699.92
61514992-1514992102.700103.17
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