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%
127.785755145742635715905707385704835725180.40
227.725736315766655751480.38
单位质量响应值RSD%判断
20609.0020748.480.48数据可信
长期12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
2024030121155474355191155332743.3444.932.3643.82%～46.04%
256738656811356775044.47
356657656541956599844.33
458586158502558544345.85
558075858129258102545.51
658727258947058837146.08
2024030221157527657474257500945.0445.702.6644.42%～46.97%
257835458195558015445.44
359958460024559991446.99
456539156278656408844.18
557809757615057712445.20
660562060308660435347.33
2024030321159867860077859972846.9746.472.6845.17%～47.78%
259232959125859179446.35
360058760103860081247.06
456566256353556459844.22
559070459276759173646.35
661225261072361148847.89
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%
127.729911649944979944599924979900449925320.20
227.729944239976439960330.23
单位质量响应值RSD%判断
35805.6335931.930.25数据可信
长期12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
2024030121195788294917195352640.6842.302.3341.27%～43.33%
298011497840097925741.78
398808798698498753642.13
410107321009443101008843.09
510032621002153100270842.78
610137711016968101537043.32
2024030221199371999298999335442.3842.942.6641.75%～44.14%
210003241004533100242842.76
310340791035679103487944.15
497545997210197378041.54
599516199068299292242.36
610452231040291104275744.48
2024030321110347241034724103472444.1443.662.8542.35%～44.96%
210186931019694101919443.48
310329451036019103448244.13
497260196958997109541.43
510213621022515102193843.60
610571321059997105856445.16
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%
127.785727785742725717205718755711015723490.22
227.725746135750905748520.06
单位质量响应值RSD%判断
20602.9220737.810.47数据可信
中间条件12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
2024030121160973360883160928247.7446.983.4745.28%～48.69%
263120363000863060649.41
360123360154960139147.12
459571859819459695646.77
558942159531559236846.41
656731856745956738844.46
2024030221163976164052564014350.1648.093.5346.31%～49.87%
259272159648259460246.59
359950859838359894646.93
464105064197364151250.27
559581659911559746646.81
660837861100960969447.77
2024030321163339363379363359349.6446.823.3745.17%～48.47%
259620859593359607046.70
359503159412459457846.59
457156857095657126244.76
559492559922559707546.78
659097859456859277346.45
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%
127.729919769959029961139933419900649934790.27
227.729957159947039952090.08
单位质量响应值RSD%判断
35839.7935902.200.13数据可信
中间条件12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
2024030121110540041052611105330844.9344.193.6242.51%～45.87%
210927411094111109342646.64
310377751036127103695144.23
410291281033211103117043.99
510176611025795102172843.58
697795198082597938841.78
2024030221111103531107989110917147.3145.263.7043.50%～47.01%
210211431024876102301043.64
310411481038806103997744.36
411106601111908111128447.40
510300791033025103155244.00
610484681052785105062644.82
2024030321110962241098942109758346.8244.063.3842.50%～45.62%
210284121025390102690143.80
310268131025966102639043.78
498973799250499112042.28
510299491033498103172444.01
610221001025529102381443.67
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