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%
110.991443285144476414447901442635144294014436830.08
211.211466622146502714658240.08
单位质量响应值RSD%判断
131363.33130760.390.33数据可信
稳定性考察-长期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%
30min11057291053491055397.1406.921.897.146.921.89
21015171013181014186.8616.86
31021031017501019266.8956.90
41006431004211005326.8016.80
51039131035611037377.0187.02
61009761008161008966.8266.83
120min138571838581238576526.09826.331.6326.1126.341.63
239763239815439789326.91826.93
339468439439839454126.69126.70
438959838931938945826.34726.36
538653538726438690026.17426.18
638224237855438039825.73425.74
240min182903082617482760255.98857.682.5556.0457.732.55
286092285963686027958.19958.25
385173985126585150257.60557.66
484815684906084860857.40957.46
589095488972189033860.23360.28
683767783699383733556.64756.70
480min1152874915273391528044103.374102.690.99103.51102.830.99
2152363415242511523942103.097103.23
3151860515189711518788102.748102.88
4151607215136521514862102.482102.62
5153194715320081531978103.640103.78
6149029314897701490032100.803100.94
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%
110.991442018144181314423371441518144277414420920.04
211.211468156146594714670520.11
单位质量响应值RSD%判断
131218.56130869.940.19数据可信
稳定性考察-长期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%
30min11018051018091018076.8886.728.856.896.728.84
29560595704956546.4726.47
39780897709977586.6146.61
41044491043071043787.0627.06
58524285278852605.7695.77
61113241110691111967.5247.52
120min138066238015438040825.73824.977.7725.7524.987.78
234137634188234162923.11523.12
336026136086436056224.39624.41
440201740197740199727.19927.21
533300733284433292622.52622.53
639668139654739661426.83526.85
240min184488284483884486057.16354.059.6357.2154.109.63
273245073312773278849.58149.62
377421477495977458652.40952.46
488480588560988520759.89359.94
569307069444169375646.94046.98
686181386266586223958.33958.39
480min1150916715083651508766102.08399.945.12102.22100.075.12
2152510115245141524808103.169103.29
3149648614976271497056101.291101.42
4149957814986081499093101.429101.57
513246681323857132426289.60089.71
6150826715084221508344102.055102.19
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%
110.991436368143605914365001434448143904814364850.12
211.211469762146976414697630.01
单位质量响应值RSD%判断
130708.37131111.780.22数据可信
稳定性考察-长期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%
30min19245392573925136.2666.855.616.276.855.58
21064431065061064747.2117.21
31026281032221029256.9716.97
41075311075171075247.2837.28
59928898862990756.7106.71
69819497869980326.6406.64
120min136640236575536607824.79425.763.1024.8025.773.09
238158038156138157025.84425.85
337507337576837542025.42725.44
440073240079040076127.14327.15
537469037447937458425.37025.38
638382338407338394826.00526.01
240min187782887599087690959.39357.192.6659.4457.242.66
281343981376181360055.10555.15
385834685810185822458.12758.18
483948983844683896856.82356.87
582850682874082862356.12256.17
684916885056084986457.56157.61
480min1149116514933551492260101.070101.890.77101.21102.020.77
2152013215201401520136102.958103.09
3149109914918791491489101.018101.15
4150963915088461509242102.220102.36
5151165015129721512311102.428102.56
6150108814997711500430101.623101.76
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