诺氟沙星胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)0
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.873925024392797439303423929839392884639284050.06
29.863906101390412439051120.04
单位质量响应值RSD%判断
398014.69396055.980.35数据可信
长期9月-供试品溶液-pH4.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
25031批1399851239999643999238100.3399.522.2097.23%~101.82%
2399948540026754001080100.37
338036853806436380506095.45
4400103540006824000858100.37
539422313943632394293298.91
6405750540518404054672101.72
25032批1425536342592934257328106.80101.183.2197.77%~104.58%
2402011240206964020404100.86
3405259640596234056110101.75
438626753861628386215296.89
539784943971532397501399.72
6402595840292404027599101.04
25033批1401317140125664012868100.67101.471.5599.82%~103.12%
2402987540282264029050101.07
3414071541399974140356103.87
4409835240971754097764102.80
5401754840204304018989100.82
639684413969610396902699.57
诺氟沙星胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)0
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.873925275392422739239053922258392313339237600.03
29.863927631392679739272140.02
单位质量响应值RSD%判断
397544.07398297.570.14数据可信
中间条件9月-供试品溶液-pH4.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
25031批1400729840038834005590100.26100.483.0797.25%~103.72%
237842783787809378604494.77
3406972040698984069809101.87
4406151440612434061378101.66
5401281140133024013056100.45
6414978741502774150032103.88
25032批1402025240159664018109100.57101.120.71100.38%~101.87%
2404637440444164045395101.26
3404436540427124043538101.21
4407469240781564076424102.03
5399669139987013997696100.06
6405942140593414059381101.61
25033批1399523739984463996842100.04100.852.6698.04%~103.66%
2404042440418254041124101.15
3406267440629844062829101.69
438356553836665383616096.02
5409134340922494091796102.42
6414587141475044146688103.79
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