沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.462894062889552887012887552888272889290.10
228.472915932919092917510.08
单位质量响应值RSD%判断
10152.1110247.660.67数据可信
影响因素5天-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024032721批132933532931232932456.3756.141.5355.24%～57.04%
232202532224732213655.14
332391532387032389255.44
433534133519533526857.39
533162533183933173256.78
632570232557232563755.74
2024032421批131726631727631727154.3155.572.3254.22%～56.92%
231308231329431318853.61
333166833158533162656.77
432833932838532836256.21
532764532743232753856.07
632972532977032974856.45
2024032421批130695630703530699652.5555.123.2353.26%～56.99%
231333031315831324453.62
333478133508433493257.33
433003132987532995356.48
532472032454432463255.57
632247432245232246355.20
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.464999074993564991744991474992764993720.07
228.475012325015335013820.05
单位质量响应值RSD%判断
17546.4517610.890.26数据可信
影响因素5天-供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024032721批156873756876356875053.3753.151.8152.14%～54.16%
255441455476955459252.04
355898255895755897052.45
458205858194858200354.61
557312857347157330053.80
656078756060556069652.61
2024032421批154762554745154753851.3852.522.2751.27%～53.77%
254011554040654026050.70
357250357234657242453.71
456584356612756598553.11
556471156426256448652.97
656741156713756727453.23
2024032421批152794152807552800849.5552.153.4050.29%～54.01%
254040554054754047650.72
357861257915557888454.32
457096057064057080053.56
556044256003256023752.57
655597555607555602552.18
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.465818085812415809155810235812935812560.06
228.475923035917195920110.07
单位质量响应值RSD%判断
20423.6120794.201.28数据可信
影响因素5天-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024032721批161119761093761106751.7751.924.3049.58%～54.26%
257985557985857985649.13
362411962420462416252.88
465783165744565763855.72
560421760408960415351.19
660002959972659987850.82
2024032421批158608958609658609249.6652.113.9349.96%～54.25%
259224559221959223250.18
361432861426761429852.05
461148061177661162851.82
564332464317964325254.50
664241264239264240254.43
2024032421批161886061843961865052.4250.602.3749.35%～51.86%
260207960193760200851.01
359043559034559039050.02
458131758102458117049.24
560564960588860576851.32
658571458566958569249.62
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.461003905100500510068451007410100779610061920.17
228.471021201102172010214600.04
单位质量响应值RSD%判断
35354.6035878.471.05数据可信
影响因素5天-供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024032721批110541601054008105408448.8248.894.4546.61%～51.17%
299590799632799611746.14
310764051076740107657249.86
411346411134022113433252.54
510421091042101104210548.27
610304541029789103012247.71
2024032421批110112051010670101093846.8249.164.0347.08%～51.24%
210210391020545102079247.28
310596491058817105923349.06
410553951056026105571048.90
511122281111703111196651.50
611093581110539110994851.41
2024032421批110694161068598106900749.5147.632.5146.38%～48.89%
210346351034407103452147.91
310176331017641101763747.13
499913199907499910246.27
510429101043702104330648.32
610072361007514100737546.66
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