氟伐他汀钠片项目信息
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%
111.211434521143434314348221435315143478714347580.03
211.161448973144593314474530.15
单位质量响应值RSD%判断
127989.12129700.090.94数据可信
加速6月-供试品溶液-X0734批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1421976-42197629.04026.9910.1329.0426.9910.12
2395809-39580927.23927.24
3393794-39379427.10027.10
4422760-42276029.09429.09
5403865-40386527.79327.79
6315294-31529421.69821.70
480min1869426-86942659.83256.529.1259.8856.569.12
2841947-84194757.94157.98
3855586-85558658.88058.92
4827910-82791056.97557.02
5861057-86105759.25659.30
6671430-67143046.20746.24
720min11256577-125657786.47582.776.6286.6182.906.63
21241574-124157485.44385.57
31250859-125085986.08286.21
41164433-116443380.13480.26
51247168-124716885.82885.96
61056043-105604372.67572.78
960min11460120-1460120100.483100.941.38100.75101.181.39
21487809-1487809102.388102.64
31476899-1476899101.638101.90
41486814-1486814102.320102.57
51439779-143977999.08399.34
61448785-144878599.70399.91
1200min11453114-1453114100.001100.701.39100.41101.101.39
21479853-1479853101.841102.25
31472511-1472511101.336101.75
41486661-1486661102.309102.71
51431675-143167598.52598.93
61455712-1455712100.179100.54
1440min11421226-142122697.806100.121.4198.37100.681.39
21450829-145082999.843100.41
31464590-1464590100.790101.35
41477135-1477135101.654102.21
51444952-144495299.43999.99
61470798-1470798101.218101.73
极限11440439-144043999.12899.851.2699.84100.551.26
21461863-1461863100.603101.31
31459438-1459438100.436101.15
41473208-1473208101.384102.09
51421492-142149297.82598.53
61449267-144926799.736100.40
氟伐他汀钠片项目信息
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%
111.211427367142682714264181426044142631914265950.04
211.161436988143491514359520.11
单位质量响应值RSD%判断
127260.93128669.530.78数据可信
加速6月-供试品溶液-X0734批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1474991-47499132.91229.486.3932.9129.486.39
2417821-41782128.95128.95
3405527-40552728.09928.10
4404237-40423728.01028.01
5437843-43784330.33830.34
6412165-41216528.55928.56
480min1954956-95495666.16959.757.1566.2259.797.15
2838452-83845258.09658.14
3827167-82716757.31557.36
4782368-78236854.21054.25
5909209-90920962.99963.04
6861395-86139559.68659.73
720min11288111-128811189.25385.873.8789.4086.003.87
21231154-123115485.30785.44
31236735-123673585.69485.82
41157367-115736780.19480.32
51286841-128684189.16589.31
61235157-123515785.58485.72
960min11472810-1472810102.051101.860.98102.33102.120.97
21470073-1470073101.862102.12
31492764-1492764103.434103.69
41464900-1464900101.503101.75
51448372-1448372100.358100.63
61470959-1470959101.923102.18
1200min11467839-1467839101.707101.330.97102.14101.740.96
21460988-1460988101.232101.64
31484663-1484663102.873103.28
41459221-1459221101.110101.51
51441267-144126799.866100.29
61460314-1460314101.185101.60
1440min11460373-1460373101.189100.940.91101.78101.510.91
21454905-1454905100.811101.37
31477673-1477673102.388102.95
41454041-1454041100.751101.30
51436387-143638799.527100.10
61457461-1457461100.988101.55
极限11457560-1457560100.995100.840.91101.73101.550.91
21452099-1452099100.616101.33
31476899-1476899102.335103.05
41453436-1453436100.709101.41
51435577-143557799.471100.19
61456040-1456040100.889101.61
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