沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.275728365742525744485743095735095738710.12
228.325742825744905743860.03
单位质量响应值RSD%判断
20299.6520281.990.07数据可信
加速3月-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
2024030121160279160361860320448.1549.863.3148.13%～51.59%
263896363946363921351.02
359491859528459510147.50
463564363562863563650.74
562918562893662906050.21
664553964622864588451.55
2024030221165006364996165001251.8850.862.1849.70%～52.03%
264561264559464560351.53
362514062376562445249.84
462873362963462918450.22
562141362119262130249.59
665285865307665296752.12
2024030321165095465100365097851.9650.512.7849.04%～51.98%
260376460446760411648.22
364323064379064351051.36
464442364458564450451.44
562111662104762108249.57
663207063311563259250.49
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.279927399951759957259950839949769947400.12
228.329955969954129955040.02
单位质量响应值RSD%判断
35187.1235151.980.08数据可信
加速3月-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
2024030121110386021040227103941445.2246.903.3245.27%～48.54%
211040651104451110425848.04
310282811029110102869644.76
410971541098646109790047.77
510845641082562108356347.14
611138241115735111478048.50
2024030221111205041122372112143848.7947.842.2146.73%～48.95%
211172441114717111598048.55
310775941076984107728946.87
410856471086453108605047.25
510705431070515107052946.58
611267411124952112584648.98
2024030321111259401125627112578448.9847.552.9246.09%～49.00%
210412841040369104082645.28
311112301108939111008448.30
411176841115663111667448.58
510723011072514107240846.66
610912431091131109118747.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.275736865743025748125747125749995745020.10
228.325737845723455730640.18
单位质量响应值RSD%判断
20321.9720235.310.31数据可信
长期3月-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
2024030121157796057771557783846.1548.285.1645.66%～50.89%
264538964591164565051.57
364071964107464089651.19
458278958332158305546.57
557913957921657917846.26
660046259954360000247.92
2024030221158776658927558852047.0048.903.9146.89%～50.90%
265292265207665249952.11
361788361766561777449.34
458639358751658695446.88
561198261201861200048.88
661530861593761562249.17
2024030321163694863845763770250.9348.633.8146.69%～50.58%
261319561352861336248.99
361597561522461560049.17
462423562455262439449.87
557864257834657849446.20
658395658407058401346.64
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.279960819940489963419962119962079957780.10
228.329933459943029938240.07
单位质量响应值RSD%判断
35223.8435092.660.27数据可信
长期3月-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
2024030121199480199409099444643.2845.445.3142.92%～47.97%
211173451118983111816448.67
311078451107573110770948.21
410056291006177100590343.78
510010491002239100164443.59
610386501035481103706645.14
2024030221110179851018983101848444.3346.064.0644.10%～48.02%
211329981131446113222249.28
310652441066440106584246.39
410116291013393101251144.07
510571691057515105734246.02
610610651065399106323246.27
2024030321110995561099611109958447.8645.733.9143.86%～47.60%
210602611060857106055946.16
310632131062995106310446.27
410778411079288107856446.94
599663799440699552243.33
610068391006551100669543.81
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