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%
128.031154555115425911550101154531115391211544530.04
227.971161323116135711613400.01
单位质量响应值RSD%判断
41186.3441520.920.58数据可信
加速6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
2024030121110873211087955108763842.6046.708.8742.36%~51.05%
213086791307847130826351.24
311151361114853111499443.67
411449411145880114541044.86
513407951341150134097252.52
611587841156177115748045.33
2024030221112828561281989128242250.2347.228.0843.22%~51.22%
211545381155703115512045.24
312741281274987127455849.92
413111111311124131111851.35
510688521066635106774441.82
611437611141078114242044.74
2024030321111473471147176114726244.9346.067.3042.54%~49.59%
211289981130089112954444.24
310932881093127109320842.82
411377221137094113740844.55
513283031331003132965352.08
612199901218824121940747.76
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%
128.032005261200481920046342005937200676020054820.05
227.972006912200799120074520.04
单位质量响应值RSD%判断
71547.7071771.610.23数据可信
加速6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
2024030121118769771876554187676640.0844.009.1039.80%~48.19%
222661832264782226548248.38
319214261921697192156241.03
419756171976411197601442.19
523233822324208232379549.62
619975401998649199809442.67
2024030221122184352220093221926447.3944.508.2340.66%~48.34%
219944891994544199451642.59
322046692205297220498347.08
422699992272417227120848.50
518451371840881184300939.35
619724281970355197139242.10
2024030321119840411984588198431442.3743.447.3940.08%~46.81%
219506501951835195124241.67
318915051892619189206240.40
419678401966114196697742.00
523026302307202230491649.22
621075562106822210718945.00
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%
128.031155403115394711562581155778115698511556740.10
227.971163600116359811635990.01
单位质量响应值RSD%判断
41229.9041601.680.64数据可信
长期6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
2024030121112660521262722126438749.4545.497.0042.15%~48.83%
211033181101024110217143.10
311216211121069112134543.85
411045701104924110474743.20
512724141269682127104849.71
611163561115226111579143.63
2024030221112896701291053129036250.4649.475.3946.68%~52.27%
212750011276316127565849.89
312402661241003124063448.52
413227671321923132234551.71
511407681140739114075444.61
613208221320846132083451.65
2024030321111660481165215116563245.5845.918.0342.04%~49.78%
212664841267154126681949.54
310795611079644107960242.22
411498331149261114954744.95
510782771077982107813042.16
613040881304624130435651.01
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%
128.032008375200584220098022006499200970720080450.10
227.972015001201449020147460.02
单位质量响应值RSD%判断
71639.1472032.390.39数据可信
长期6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
2024030121121891142185394218725446.5942.837.1639.61%~46.04%
219051841901709190344640.55
319393461937837193859241.29
419062041906548190637640.61
522060082201290220364946.94
619251411922684192391240.98
2024030221122313972233830223261447.5646.665.4743.99%~49.34%
222079662207978220797247.03
321496442149099214937245.78
422951002292264229368248.86
519721421972465197230442.01
622887982288024228841148.75
2024030321120131322015822201447742.9143.248.2139.51%~46.96%
221953892197720219655446.79
318620161864719186336839.69
419818381983011198242442.23
518628631862148186250639.67
622587692260007225938848.13
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%
128.031152918115519711543281153806115190111536300.12
227.971152961115104811520040.12
单位质量响应值RSD%判断
41156.9741187.130.06数据可信
中间条件6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
2024030121111994121198437119892447.1646.796.8943.41%~50.17%
211083041105255110678043.54
311044661106342110540443.48
413167391315680131621051.78
512440731243198124363648.92
611653381166934116613645.87
2024030221111928361193057119294646.9347.576.7844.19%~50.95%
213134221314915131416851.70
313005861300345130046651.16
411108061109796111030143.68
511896921189274118948346.79
611476971148113114790545.16
2024030321111755211175992117575646.2547.819.2243.18%~52.43%
213133141312669131299251.65
311387021138618113866044.79
410468611047613104723741.20
513132701314644131395751.69
613032171303578130339851.27
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%
128.032001504200435020044762001308199948120022240.11
227.971999377199744619984120.07
单位质量响应值RSD%判断
71431.4771448.410.02数据可信
中间条件6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
2024030121120733812070606207199444.3844.067.0240.82%~47.31%
219130471911580191231440.96
319089881909691190934040.90
422823152281815228206548.88
521519922149646215081946.07
620167612017318201704043.20
2024030221120631302064637206388444.2144.826.9941.53%~48.11%
222800602281948228100448.86
322538802253843225386248.28
419154071915845191562641.03
520569872054887205593744.04
619833211984074198369842.49
2024030321120316882031679203168443.5245.049.3740.61%~49.46%
222744052272832227361848.70
319646951965978196533642.10
418087171809469180909338.75
522743262276084227520548.73
622603472260505226042648.42
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%
128.031163175116501711637261164023116145211634790.12
227.971164777116624411655100.09
单位质量响应值RSD%判断
41508.3541670.000.28数据可信
-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
2024030121111693811169383116938245.5446.045.3443.46%~48.62%
212374991237394123744648.19
311344281133131113378044.15
412676451267333126748949.36
511862971187437118686746.22
610979131099284109859842.78
2024030221111787231179019117887145.9148.363.5446.56%~50.15%
212820851282084128208449.93
312922441291750129199750.31
412545081254528125451848.85
512383391238246123829248.22
612046921205021120485646.92
2024030321112091161209209120916247.0948.416.4245.15%~51.67%
211288501129347112909843.97
313169191317022131697051.29
411869311186286118660846.21
513242621325319132479051.59
612917421291422129158250.30
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%
128.032016467201870320174542019799201536120175570.09
227.972014741201550020151200.03
单位质量响应值RSD%判断
71978.4972045.760.07数据可信
-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
2024030121120182512017720201798642.8843.395.5940.84%~45.93%
221388262138422213862445.44
319500621949108194958541.43
422003002198912219960646.74
520510082050716205086243.58
618946051894608189460640.26
2024030221120362612036157203620943.2745.653.6943.88%~47.41%
222220772222360222221847.22
322366802235287223598447.51
421721282171560217184446.15
521461342145048214559145.59
620781782076783207748044.14
2024030321120893862089616208950144.4045.676.6142.51%~48.84%
219454961945539194551841.34
322828102282625228271848.50
420497162050952205033443.57
522920652292886229247648.71
622361882236450223631947.52
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