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%
128.272867772877592875882891302876662877840.30
228.322852402869352860880.42
单位质量响应值RSD%判断
10179.8410101.980.55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
2024030121133160232957033058652.8051.632.2050.44%～52.82%
231352231369531360850.09
331454031644331549250.39
432738032697932718052.25
532866932865032866052.49
632416832405232411051.76
2024030221132606032510532558252.0051.701.6050.83%～52.56%
232161932110532136251.33
333179233377333278253.15
432311732364832338251.65
531720531821531771050.74
632051632212432132051.32
2024030321131896231895331895850.9450.292.7948.82%～51.76%
230410830429830420348.58
330422930210130316548.42
431922531916931919750.98
532309532223032266251.53
632113132088032100651.27
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%
128.274977294993294999415015655003424997810.29
228.324968784979104973940.15
单位质量响应值RSD%判断
17678.8517563.350.47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
2024030121157289157167557228349.7048.702.1147.62%～49.77%
254494054503754498847.33
354615354942854779047.57
456769856519156644449.19
557041057262757151849.63
656149856134556142248.75
2024030221156569756431856500849.0648.721.6047.90%～49.54%
255799955570955685448.36
357450657919957685250.09
456009356091156050248.67
555190055083055136547.88
655391255779255585248.27
2024030321155390955448755419848.1347.322.8945.89%～48.75%
252642852635252639045.71
352527352142852335045.45
455173755149555161647.90
555767755770555769148.43
655660055611355635648.31
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%
128.272831952850552867952876192865972858520.62
228.322854152859622856880.14
单位质量响应值RSD%判断
10111.5010087.850.17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
2024030121131068030972731020449.7451.123.0549.49%～52.75%
232767132804032785652.58
332438232425832432052.01
430428230276530352448.67
532508932511932510452.13
632188232169132178651.60
2024030221132121932048732085351.4551.831.4951.02%～52.64%
233092033139233115653.10
332640632715732678252.40
431827731800831814251.02
532091232005732048451.39
632137232232132184651.61
2024030321130802630991530897049.5551.262.1450.12%～52.41%
232337032376132356651.89
332733432722932728252.48
432230931990432110651.49
531395231414931405050.36
632258032354132306051.81
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%
128.274928464954014982484988174989434968510.54
228.324943064961314952180.27
单位质量响应值RSD%判断
17575.2017486.510.36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
2024030121153723553582653653046.8348.143.0546.61%～49.68%
256701256671356686249.48
356189956298856244449.09
452632252455652543945.86
556444056146356295249.14
655525055537455531248.47
2024030221155730555379155554848.4948.911.4548.16%～49.65%
257355057531357443250.14
356466856442056454449.28
455154155191155172648.16
555674855643555659248.58
655879755947955913848.80
2024030321153172453435353303846.5348.262.2647.12%～49.40%
255888856239956064448.94
356647356778856713049.50
455858655318755588648.52
554320454304054312247.41
655724555763755744148.66
点击查看处理图标(自动生成)
　
原始图谱下载图谱(谢鑫慧 于 2024-07-16 12:00:26 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-07-16 12:00:37 完成)
Current page cost:46 ms