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%
110.741408358140973414069681409602141078414090890.11
211.231479036147899514790160.01
单位质量响应值RSD%判断
131200.09131702.230.28数据可信
稳定性考察-影响因素10天包装高温50℃-供试品溶液-2024022621批-shui
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min17525775339752985.0795.1410.305.085.1410.31
27697276917769445.1905.19
37845878478784685.2935.29
46142861357613924.1414.14
58419183931840615.6705.67
68052780743806355.4395.44
120min128010027986927998418.88519.918.5118.8919.928.51
229182229159329170819.67619.68
329234329290429262419.73819.75
425967625908225937917.49517.50
532481532437632459621.89421.90
632239732296132267921.76521.77
240min159461159610059535640.15745.3910.4840.1945.4310.48
265056564942664999643.84343.88
363746763638163692442.96143.00
463392763452663422642.77942.81
575147675192275169950.70350.74
677049476841476945451.90051.94
480min112944611293613129403787.28496.205.1987.3896.315.19
214034161402410140291394.62894.73
314357871438100143694496.92397.03
414376821438588143813597.00397.10
5148237414852011483788100.083100.20
6150034415032331501788101.297101.42
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%
110.741410711140612414097101412349141117914100150.17
211.231479192148285514810240.18
单位质量响应值RSD%判断
131286.31131881.030.32数据可信
稳定性考察-影响因素10天包装高湿-供试品溶液-2024022621批-shui
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min18252482674825995.5665.435.465.575.435.47
28514785154851505.7385.74
38152081458814895.4915.49
47640376330763665.1465.15
58363483570836025.6335.63
67391974026739724.9844.98
120min131451231403931427621.17721.154.6621.1921.164.66
232302632243232272921.74621.76
331507431392831450121.19221.20
429013528846528930019.49419.50
533263333317733290522.43222.44
630930630945030937820.84720.85
240min173749173801373775249.71247.016.1149.7547.056.11
268381768374168377946.07546.12
373631673488173559849.56749.61
462301662388962345242.01042.05
571344071575371459648.15248.19
669035169091769063446.53746.58
480min114402951439441143986897.02397.923.3997.1498.033.39
2151189415074771509686101.727101.84
314397311443127144142997.12897.24
413679501369561136875692.23192.33
5148644114827991484620100.038100.15
614715461478187147486699.38199.49
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%
110.741406655140673014068561408831140865414075450.08
211.231469066146911114690880.01
单位质量响应值RSD%判断
131056.33130818.170.13数据可信
稳定性考察-影响因素10天包装光照-供试品溶液-2024022621批-shui
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min18066280979808205.4735.447.845.475.447.82
27775677994778755.2735.27
38548585391854385.7855.79
47091071026709684.8064.81
57763777902777705.2665.27
68877988757887686.0116.01
120min131975231924331949821.63521.307.7921.6421.317.78
231730531719631725021.48321.49
334205134233634219423.17223.18
427527227501227514218.63118.64
529879629889829884720.23720.24
633495133419633457422.65622.66
240min165955666094766025244.70946.769.9844.7546.809.98
273951374033373992350.10450.14
379426179603079514653.84453.89
459780959652859716840.43740.47
566588966216766402844.96545.00
668704568608868656646.49146.53
480min1148432614857241485025100.559100.741.08100.67100.841.08
2148675014873451487048100.696100.81
3149727314986461497960101.435101.56
414620681460361146121498.94799.04
5148625014849201485585100.597100.70
6150841215094331508922102.177102.29
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%
110.741400120140087514098451401504140310014030890.29
211.231471041146880514699230.11
单位质量响应值RSD%判断
130641.43130892.520.14数据可信
稳定性考察-影响因素10天裸放高温50℃-供试品溶液-2024022621批-shui
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min17343873425734324.9795.3116.224.985.3116.21
27801278077780445.2925.29
37688576711767985.2075.21
49677296781967766.5626.56
58603586181861085.8385.84
65869859008588533.9903.99
120min128734328785028759619.50020.0511.8819.5120.0611.88
228235128263428249219.15419.16
329883329926529904920.27720.28
433965633925333945423.01623.03
532584832540232562522.07922.09
624005323998524001916.27416.28
240min167332967638367485645.75844.779.2145.7944.809.21
261609261634361621841.78241.82
371099571072471086048.19948.24
472752972852472802649.36349.41
566666366653266659845.19845.24
656461156504556482838.29738.33
480min1149893514991041499020101.63997.748.05101.7497.848.05
2147758814771751477382100.172100.27
3147768714770721477380100.172100.28
4150147515009521501214101.788101.91
5148712414897711488448100.922101.03
612058091205398120560481.74481.83
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