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%
110.991440930144439914454461438112143958914416950.22
211.211464004146364214638230.02
单位质量响应值RSD%判断
131182.44130581.890.33数据可信
中间条件6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%
30min11022051017971020016.9106.574.126.916.574.13
29884298665987546.6906.69
39814097757979486.6356.64
48984789989899186.0916.09
59739297114972536.5886.59
69621096328962696.5226.52
120min135413235403635408423.98724.754.2624.0024.764.26
237632837636737634825.49525.51
335766035765635765824.22924.24
434855834834934845423.60623.61
536514636543136528824.74624.76
638977039045139011026.42826.44
240min175927175879575903351.42052.796.1651.4752.846.16
282305082228982267055.73155.78
373008472988972998649.45249.50
473911973926073919050.07650.12
577387277364977376052.41852.46
685128285064985096657.64857.70
480min1150025015002431500246101.633101.211.45101.76101.341.45
2148776314882631488013100.804100.94
3149848414973221497903101.474101.59
414552301454750145499098.56798.69
5150345615036411503548101.857101.98
6151901215193031519158102.914103.05
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%
110.991435950143642814362171436186143671514362990.03
211.211462221146214414621820.01
单位质量响应值RSD%判断
130691.45130435.500.14数据可信
中间条件6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%
30min11048901049501049207.1256.794.977.136.795.00
21038881039891039387.0587.06
31034391034841034627.0267.03
49471594973948446.4416.44
59905199215991336.7326.73
69326393412933386.3396.34
120min141208441161741185027.96825.955.8327.9825.965.83
240125040183940154427.26927.28
338566138569938568026.19126.20
435510435496335503424.11024.12
537791737766637779225.65625.67
636104236079736092024.51024.52
240min187694587676887685659.54756.786.0759.6056.836.06
286676786688886682858.86658.92
385670885877885774358.24958.30
474089774052174070950.30150.35
581897381908581902955.62055.67
685575085526185550658.09758.14
480min1150613415069811506558102.309101.530.66102.45101.660.66
2149484514953901495118101.532101.67
3150496015050881505024102.205102.34
4148744014870091487224100.996101.12
5148149914816141481556100.611100.74
6149486614949301494898101.517101.65
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%
110.991437000143682014358691435904143569614362580.05
211.211460320146049514604080.01
单位质量响应值RSD%判断
130687.72130277.250.23数据可信
中间条件6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%
30min11012321015021013676.8886.258.866.896.258.87
29775497980978676.6506.65
37989679977799365.4325.43
49599495980959876.5226.52
59207391838919566.2496.25
68510684975850405.7795.78
120min136139536119036129224.55024.246.2224.5624.256.22
238400238441338420826.10826.12
332417032452832434922.04022.05
433811233919433865323.01223.02
535779435746235762824.30124.31
637425637400637413125.42325.43
240min177059177072477065852.36753.9810.5452.4154.0210.53
290865790860590863161.74361.79
370254270263970259047.74247.78
471406271319171362648.49248.54
579600079586679593354.08554.13
687411187482887447059.42259.47
480min1151792015175471517734103.132101.153.49103.26101.283.50
2150158715023441501966102.061102.20
313862261387076138665194.22594.34
4149844514985591498502101.825101.94
5149442314939881494206101.534101.66
6153249615326561532576104.141104.28
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