氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677118071979709917108970933712340.60
210.757053070335704320.20
单位质量响应值RSD%判断
6676.106551.811.33数据可信
供试品溶液-2024041721批-pH1.0盐酸溶液-无水乙醇（60:40）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min111479-114791.6031.4510.941.601.4510.94
210388-103881.4511.45
39074-90741.2671.27
411193-111931.5631.56
58909-89091.2441.24
611212-112121.5661.57
30min118890-188902.6382.706.682.652.726.70
219917-199172.7822.80
317082-170822.3862.40
420569-205692.8732.89
519227-192272.6852.70
620431-204312.8542.87
45min120532-205322.8683.118.062.913.158.05
224021-240213.3553.40
319991-199912.7922.83
423564-235643.2913.34
521574-215743.0133.05
623889-238893.3373.38
60min127125-271253.7883.876.433.863.956.50
229025-290254.0544.13
324630-246303.4403.50
428491-284913.9794.06
527547-275473.8473.92
629630-296304.1384.22
75min126290-262903.6723.726.373.783.836.37
228291-282913.9514.07
323490-234903.2813.38
427622-276223.8583.97
526577-265773.7123.82
627437-274373.8323.95
90min129023-290234.0544.085.354.204.235.41
230582-305824.2714.43
326279-262793.6703.80
430443-304434.2524.41
529426-294264.1104.25
629535-295354.1254.28
120min127061-270613.7803.967.553.974.147.49
230510-305104.2614.46
324885-248853.4763.64
429226-292264.0824.28
527999-279993.9114.10
630256-302564.2264.42
极限136700-367005.1264.948.955.355.178.82
238436-384365.3685.61
329278-292784.0894.29
435328-353284.9345.17
536269-362695.0665.29
636414-364145.0865.33
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2500
标示量(mg)80供试品稀释倍数2系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.677075471122716787162271214712780.54
210.757103571338711860.31
单位质量响应值RSD%判断
6680.226621.950.62数据可信
供试品溶液-2024041721批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
15min18499-84991.1801.286.791.181.286.93
29858-98581.3691.37
38523-85231.1841.18
49917-99171.3771.38
59008-90081.2511.25
69308-93081.2931.29
30min117779-177792.4692.705.602.482.715.61
220503-205032.8472.86
318782-187822.6082.62
420574-205742.8572.87
519934-199342.7682.78
619158-191582.6612.67
45min121678-216783.0113.163.783.053.203.84
222799-227993.1663.21
321866-218663.0373.07
423871-238713.3153.36
523454-234543.2573.30
622670-226703.1483.19
60min127043-270433.7563.873.893.823.943.88
227583-275833.8313.90
328675-286753.9824.05
428688-286883.9844.06
528970-289704.0234.10
626261-262613.6473.72
75min125724-257243.5723.714.973.683.824.91
226722-267223.7113.82
326120-261203.6273.74
428260-282603.9254.04
528319-283193.9334.05
625138-251383.4913.60
90min129297-292974.0694.192.424.214.342.47
229866-298664.1484.30
330262-302624.2034.35
430979-309794.3024.46
530998-309984.3054.46
629502-295024.0974.24
120min127289-272893.7903.974.123.974.164.09
228924-289244.0174.21
328555-285553.9664.15
429500-295004.0974.29
530171-301714.1904.39
627246-272463.7843.97
极限136256-362565.0355.005.095.255.234.92
233330-333304.6294.86
335755-357554.9665.19
438041-380415.2835.52
537987-379875.2765.51
634816-348164.8355.06
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