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%
110.991425462142665714255341426394142432314256740.07
211.211470775147266114717180.10
单位质量响应值RSD%判断
129724.66131286.170.85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%
30min1138233-1382339.3927.9620.339.397.9520.32
2129536-1295368.8018.80
387976-879765.9775.98
4128525-1285258.7328.73
5132826-1328269.0249.02
685431-854315.8045.80
120min1534675-53467536.32732.1518.8736.3432.1618.87
2516022-51602235.05935.07
3372984-37298425.34125.35
4524294-52429435.62235.63
5545858-54585837.08737.10
6345493-34549323.47323.48
240min11077263-107726373.19165.2517.6373.2665.3117.64
21059603-105960371.99172.06
3770622-77062252.35752.40
41061477-106147772.11972.19
51077297-107729773.19473.26
6715744-71574448.62948.67
360min11508363-1508363102.48193.2414.53102.6693.4014.54
21479156-1479156100.497100.67
31141761-114176177.57377.70
41501502-1501502102.015102.19
51512925-1512925102.791102.97
61090758-109075874.10874.22
480min11512898-1512898102.78999.025.13103.1299.325.16
21481795-1481795100.676101.00
31389292-138929294.39194.63
41500611-1500611101.954102.28
51519879-1519879103.263103.60
61339829-133982991.03091.26
极限11505280-1505280102.272101.481.66102.76101.921.69
21480760-1480760100.606101.08
31495444-1495444101.603101.99
41500097-1500097101.919102.40
51526586-1526586103.719104.21
61453353-145335398.74399.11
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%
110.991434554143427214357721435976143750214356150.09
211.211465532146497114652520.03
单位质量响应值RSD%判断
130629.21130709.370.05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%
30min185748-857485.8185.9520.725.825.9520.72
269317-693174.7034.70
3110681-1106817.5107.51
474401-744015.0485.05
5109627-1096277.4397.44
676618-766185.1995.20
120min1392428-39242826.62827.8520.9626.6427.8620.95
2307258-30725820.84920.86
3521264-52126435.37035.38
4357233-35723324.24024.25
5508936-50893634.53334.54
6375746-37574625.49625.50
240min1852697-85269757.85960.2917.0057.9160.3417.00
2710027-71002748.17848.22
31080488-108048873.31673.38
4793763-79376353.86053.90
51065679-106567972.31172.37
6828520-82852056.21956.26
360min11252709-125270985.00286.7211.6785.1486.8611.68
21125156-112515676.34776.46
31466861-146686199.53399.71
41174361-117436179.68579.81
51459497-145949799.03399.20
61189333-118933380.70180.83
480min11461694-146169499.18298.411.6199.4598.681.64
21410211-141021195.68995.91
31469684-146968499.724100.05
41461874-146187499.19499.44
51464095-146409599.34599.67
61434004-143400497.30397.55
极限11474083-1474083100.02399.401.28100.4399.821.29
21430934-143093497.09597.46
31465278-146527899.42599.90
41486040-1486040100.834101.23
51460991-146099199.13499.60
61471981-147198199.880100.28
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