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%
111.21 1429178142914014291991429229142861014290710.02
211.161443379144275314430660.04
单位质量响应值RSD%判断
127481.80129306.991.01数据可信
中间条件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%
30min11052401053571052987.2727.024.847.277.024.86
21039551039611039587.1797.18
31017911017541017727.0287.03
41039421039581039507.1797.18
59182591889918576.3446.34
61026441026571026507.0897.09
120min139472639471139471827.25926.045.5327.2726.055.53
237324037365837344925.79025.80
339383339369839376627.19327.20
438575938571138573526.63926.65
533851733844333848023.37523.38
637654337658937656626.00626.02
240min187784587853187818860.64858.837.1360.7058.887.13
287462287476887469560.40660.46
393153793129893141864.32464.38
486312586244086278259.58459.63
575970376028575999452.48552.53
680396780402680399655.52455.57
480min1151556415158631515714104.675104.820.49104.82104.960.49
2151643615162591516348104.719104.86
3151433515147431514539104.594104.74
4153176015330231532392105.827105.97
5151114815117421511445104.380104.50
6151704915158821516466104.727104.86
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%
111.21 1418072141860514185661420360141856514188340.07
211.161433197143412914336630.05
单位质量响应值RSD%判断
126568.60128464.431.06数据可信
中间条件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%
30min19693796921969296.7406.767.086.746.767.09
29961699676996466.9296.93
31039191038581038887.2247.22
41007581006361006977.0027.00
58400884095840525.8455.84
69780897824978166.8026.80
120min133752933766133759523.47525.058.0323.4925.068.03
236167836222836195325.16925.18
339404639412839408727.40327.41
439526439570039548227.50027.51
532842532857232849822.84222.85
634371434378534375023.90323.91
240min173570273626473598351.17754.278.7651.2254.318.76
283735383764283749858.23658.28
385024285059985042059.13559.19
483815583750383782958.25958.31
570267870289170278448.86948.91
671804771787371796049.92449.97
480min1149053214900721490302103.629103.583.05103.75103.713.05
2150373715038131503775104.566104.70
3151965515180411518848105.614105.75
4150034015009921500666104.350104.49
514003321400678140050597.38597.50
6152364515234141523530105.940106.06
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%
111.21 1421333142229714222621421830142161014218660.03
211.161438611143800714383090.03
单位质量响应值RSD%判断
126839.07128880.731.13数据可信
中间条件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%
30min11023231023231023237.0966.903.507.106.903.49
29518695378952826.6086.61
39510995245951776.6006.60
41015551016561016067.0467.05
59949699624995606.9046.90
61028631028931028787.1357.13
120min141149041131041140028.53027.542.4328.5427.552.43
239291339296239293827.25027.26
339313839313839313827.26427.27
439925639904139914827.68127.69
538308038359538333826.58426.59
640258940272540265727.92427.93
240min188366588259588313061.24561.663.9261.3061.723.92
293812793717193764965.02665.08
388454388375888415061.31561.37
491052991142991097963.17663.23
588619488562788591061.43761.49
683282683312083297357.76657.82
480min1151016815112081510688104.766103.520.94104.91103.660.94
2150835615080841508220104.594104.74
3148405514857681484912102.978103.12
4148793414869061487420103.152103.30
5148852614904871489506103.297103.44
6147499314756011475297102.311102.45
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