阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662844692846232847652842372843472844880.08
210.712842502838472840480.11
单位质量响应值RSD%判断
26687.4326521.760.45数据可信
供试品溶液-阿齐沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批129525229531029528199.5999.011.9197.03%~100.98%
229617529602829610299.87
328640028638828639496.59
4301666302540302103101.89
529263529224029243898.63
628895528908328901997.48
6087549批1296435296707296571100.03101.041.7899.16%~102.93%
2302292302421302356101.98
3299303298188298746100.76
4306149306002306076103.23
529103529109229106498.17
6301681303772302726102.10
6087549批129611029637829624499.9299.431.1298.26%~100.59%
2298096298157298126100.55
328975828756528866297.36
429467329422129444799.31
5296736296444296590100.03
629475229468929472099.40
6087549批1298337299155298746100.76101.311.13100.11%~102.51%
2304475304387304431102.68
329478329508929493699.47
4299857299740299798101.11
5301219301161301190101.58
6303314302969303142102.24
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786966069731696496957969691696620.09
214.796982069881698500.07
单位质量响应值RSD%判断
4713.264722.790.15数据可信
供试品溶液-氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批169218688776904894.8895.231.9893.26%~97.21%
271103706207086297.38
368184681956819093.71
470255699717011396.35
567162674446730392.49
670269703167029296.59
6087549批166715665076661191.5494.202.4591.78%~96.61%
267163669576706092.15
368561689206874094.46
467995677986789693.30
570273702707027296.57
670646707507069897.15
6087549批167474677806762792.9392.852.8490.09%~95.61%
268695683926854494.19
364004642406412288.12
467385675366746092.70
567699677596772993.07
669695701346991496.07
6087549批164948650666500789.3393.432.9390.56%~96.30%
267079676816738092.59
367393676086750092.76
467745675576765192.96
569696699226980995.93
670650705497060097.02
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.662837562833282838352835072833072835470.09
210.712844692848992846840.11
单位质量响应值RSD%判断
26599.1626581.140.05数据可信
供试品溶液-阿齐沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批1297192297315297254100.31101.341.4399.83%~102.86%
2302184302181302182101.97
329267929332129300098.87
4303981303767303874102.54
5302826302398302612102.12
6302915303008302962102.24
6087549批1298017298517298267100.65101.941.78100.04%~103.84%
2303811302584303198102.32
3303046303074303060102.27
4309810309990309900104.58
529423429418329420899.28
6303853303902303878102.55
6087549批1298869298962298916100.87100.911.0499.82%~102.01%
2299225299603299414101.04
3296349296436296392100.02
429528129536329532299.66
5304172304085304128102.63
6299970300141300056101.26
6087549批1301365301835301600101.78102.921.41101.40%~104.44%
2306840307146306993103.60
3298074298190298132100.61
4305948306333306140103.31
5307201307280307240103.68
6309446310166309806104.55
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.786938069479694636946269552694670.09
214.797016170200701800.04
单位质量响应值RSD%判断
4700.074745.100.68数据可信
供试品溶液-氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批172066720537206098.9398.753.1495.50%~102.00%
2740697376373916101.48
371284712157125097.82
4731917291573053100.29
567853676986777693.05
6736597337473516100.93
6087549批170984713507116797.7098.781.5797.16%~100.41%
271057707877092297.37
372513724277247099.49
470890708087084997.27
5735527351973536100.96
672892726507277199.91
6087549批170242701217018296.3596.922.0294.87%~98.96%
270237700977016796.33
368810686176871494.34
470125698606999296.09
571725719667184698.64
672647726737266099.75
6087549批168431686846855894.1297.422.5494.83%~100.01%
269724697466973595.74
370475703737042496.68
471056710097103297.52
572752725807266699.76
6734187326973344100.69
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