氨氯地平替米沙坦片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.452761727448273462739527465274540.38
214.412764627433275400.55
单位质量响应值RSD%判断
1899.931911.170.42数据可信
长期45月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121125407255942550096.4099.652.3597.20%~102.10%
226278263042629199.39
326417261212626999.31
425971260652601898.36
5270422656126802101.32
6273942716427279103.13
2024030221125035248992496794.3999.853.0796.64%~103.07%
226382263972639099.77
326272262002623699.18
4263762677526576100.47
5271652740827286103.15
6271672687627022102.16
20240303211265422689226717101.0099.952.4097.43%~102.46%
2267652725427010102.11
325339255312543596.16
4272712693627104102.47
526348262392629499.40
626144259922606898.55
氨氯地平替米沙坦片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.452739927238271742726827179272520.34
214.412712526992270580.35
单位质量响应值RSD%判断
1885.951877.720.31数据可信
长期45月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121125091249262500895.7399.643.0296.49%~102.80%
225924259222592399.24
3263202640626363100.92
425465257042558497.94
5272972737727337104.65
625940259762595899.37
2024030221125778256212570098.38100.972.4398.40%~103.54%
2273002757127436105.03
3263172634626332100.80
425760257312574698.56
5265632667026616101.89
6264232643326428101.17
2024030321124912247612483695.0797.963.3494.53%~101.38%
2261462627126208100.33
325770257662576898.64
425763261182594099.30
5263552664626500101.44
624300242712428692.97
氨氯地平替米沙坦片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.452709327192272402700227160271370.35
214.412678627073269300.76
单位质量响应值RSD%判断
1877.991868.840.35数据可信
长期45月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211266042655426579102.20102.361.71100.53%~104.19%
2264022647326438101.66
3266352650926572102.18
425884259272590699.62
5271672700427086104.15
6271442712627135104.34
20240302211262242641826321101.21102.721.33101.28%~104.15%
2266292689926764102.92
3265062630826407101.54
4272332704127137104.35
5264392661326526102.00
6271012713727119104.28
20240303211267982647126634102.42103.172.12100.88%~105.46%
2275042730627405105.38
325904256812579299.18
4269302702426977103.73
5270942724727170104.48
6269662703427000103.82
氨氯地平替米沙坦片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.452710027314271852722126923271490.55
214.412674226783267620.11
单位质量响应值RSD%判断
1878.821857.180.82数据可信
长期45月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211260472589525971100.16102.182.7299.27%~105.10%
2261532592626040100.42
3269492684926899103.74
425701259222581299.55
5274812794227712106.87
6264652661526540102.35
20240302211262162607026143100.82103.442.02101.25%~105.62%
2275192724427382105.60
3264412705026746103.15
4263592609726228101.15
5271712705627114104.57
6272962732527310105.32
20240303211261742621426194101.02100.670.8899.74%~101.60%
2261712608726129100.77
3263492618026264101.29
425793259952589499.86
5262572648626372101.70
625759257802577099.38
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