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%
111.211450061145215314493921449876145042914503820.08
211.161428019142942914287240.07
单位质量响应值RSD%判断
129382.87128021.860.75数据可信
长期3月-供试品溶液-2024041521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%
30min19719597051971236.6916.485.726.696.485.73
29790597777978416.7416.74
38428884171842305.8035.80
49267792601926396.3826.38
59874398673987086.8006.80
69365193478935646.4466.45
120min133543133533033538023.10523.727.3023.1223.737.29
238766338773238769826.71026.72
332635132644432639822.48722.50
431682131663431672821.82021.83
535481635477335479424.44324.45
634428734454634441623.72823.74
240min171195171104071149649.01753.689.1549.0653.729.14
286000085985085992559.24359.29
383395783434883415257.46757.51
467692567706067699246.64046.68
578516978577678547254.11454.16
680669880651780660855.57055.62
480min1152572415253561525540105.099104.421.15105.22104.551.15
2152458215147081519645104.693104.83
3154516215428511544006106.371106.50
4150191815028051502362103.502103.61
5149731914999021498610103.244103.37
6150451115042481504380103.641103.77
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%
111.211448025144898414490641447146144826114482960.06
211.161430584142801414292990.13
单位质量响应值RSD%判断
129196.79128073.390.62数据可信
长期3月-供试品溶液-2024041721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%
30min18979389701897476.1866.222.886.196.232.88
28816088190881756.0786.08
39352794074938006.4656.47
49172191669916956.3206.32
59169591558916266.3166.32
68678786646867165.9775.98
120min130844230789430816821.24224.039.8521.2524.049.85
231829631801631815621.93021.94
338389438362338375826.45226.46
433177633162333170022.86422.87
536042236032136037224.84024.85
638945538950838948226.84626.86
240min175471375414575442952.00253.8210.0852.0453.8610.07
266433866441366437645.79445.84
387403387311387357360.21460.26
472905772916472911050.25750.30
582123882089282106556.59556.64
684250884210684230758.05958.11
480min1148225814820441482151102.163103.141.25102.28103.271.25
2147865514780141478334101.899102.01
3153024915294391529844105.450105.59
4149364014949381494289102.999103.12
5150276515028081502786103.585103.72
6149142814903401490884102.764102.90
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%
111.211441968144335014440341445924144379314438140.10
211.161426748142696314268560.02
单位质量响应值RSD%判断
128796.97127854.480.52数据可信
长期3月-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%
30min19528995397953436.5886.194.886.596.194.88
28731087407873586.0366.04
39351793507935126.4616.46
49046690410904386.2496.25
58365883680836695.7815.78
68703787191871146.0196.02
120min136502436503736503025.22224.545.4225.2324.555.42
231814931795531805221.97621.98
336721336660736691025.35125.36
436447036471936459425.19125.20
536611636612736612225.29725.31
635041134996835019024.19624.21
240min178930178934778932454.53853.997.2054.5954.047.20
267192567094567143546.39246.43
382552282543882548057.03657.08
479913279913079913155.21555.26
581847881875281861556.56256.61
678453078425178439054.19754.24
480min1150382415058501504837103.976102.822.95104.11102.942.95
214017461402504140212596.87996.99
3150538915049841505186104.000104.13
4148490214829571483930102.531102.66
5151984315210551520449105.054105.19
6151250615108921511699104.450104.58
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