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%
110.991417979141405614119111412467141182514136480.19
211.141431057142563914283480.27
单位质量响应值RSD%判断
128630.39128217.950.23数据可信
影响因素30天-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%
30min19055390838906966.2626.522.976.266.523.00
29479094863948266.5476.55
39216791920920446.3556.35
49562995615956226.6026.60
59827098992986316.8106.81
69504095173951066.5666.57
120min132441932478332460122.41125.156.9222.4225.166.92
234246234199234222723.62823.64
336887936917236902625.47825.49
438322738512938417826.52426.53
538104238083338093826.30026.31
638401238538138469626.56026.57
240min167241967312167277046.44854.489.9546.4954.539.94
271247971147771197849.15549.20
382171782140282156056.72156.77
487353287421687387460.33360.38
581843981889781866856.52156.57
683572683562983567857.69657.75
480min114362511434101143517699.085102.471.7399.20102.601.73
2150045315080231504238103.854103.97
3149129414942131492754103.061103.19
4150265315023241502488103.733103.87
5147933614798571479596102.152102.29
6149079214913501491071102.944103.08
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%
110.991398833139684713970771397698139622913973370.08
211.141415953141603014159920.01
单位质量响应值RSD%判断
127146.22127108.800.03数据可信
影响因素30天-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%
30min18410584154841305.8686.6410.715.876.6410.68
210003699922999796.9736.97
39564696035958406.6846.68
48178481582816835.6975.70
51053031052171052607.3417.34
61048301045991047147.3037.30
120min133608033581033594523.43025.258.0123.4425.268.01
237071237034437052825.84225.85
335249535287035268224.59824.61
432662332843832753022.84322.85
540368240559540463828.22128.23
638100238071538085826.56326.57
240min173456673205773331251.14555.478.2951.1955.528.28
284693184587284640259.03259.08
377810677893477852054.29854.34
470684670616370650449.27549.32
584182484252784217658.73758.79
686352786661586507160.33460.38
480min114022081402087140214897.792101.633.3197.91101.763.32
2146984214703661470104102.532102.67
3148440014818301483115103.439103.57
413917311391887139180997.07197.19
5150533315058741505604105.008105.15
6148979614910051490400103.947104.09
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%
110.991411601141590514123941411890141126414126110.14
211.141411150141307914121140.10
单位质量响应值RSD%判断
128536.03126760.680.99数据可信
影响因素30天-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%
30min19780097495976486.7836.7910.416.786.8010.40
29729197160972266.7546.75
31082771079431081107.5107.51
49994699744998456.9366.94
51050351051271050817.2997.30
67896979009789895.4875.49
120min139569539724239646827.54026.4310.7327.5526.4410.72
241917041988141952629.14229.15
338740538783738762126.92526.94
434894734686234790424.16724.18
531589431580931585221.94021.95
641485441703241594328.89328.90
240min185588585710685649659.49556.2510.1359.5556.3010.13
288344988367088356061.37561.43
384348984339784344358.58858.64
470608470666270637349.06749.11
586456286451086453660.05460.10
670406470397870402148.90448.96
480min1150931215089821509147104.831101.883.00104.97102.022.99
2146864814683151468482102.006102.15
3149429214936171493954103.775103.91
4146164114669451464293101.715101.84
5148113114798201480476102.839102.97
613834121384122138376796.12196.25
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