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%
110.312836142841512838752838772838582838750.07
210.242838602835572837080.08
单位质量响应值RSD%判断
27533.9527705.860.45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
20240301211316082316016316049102.68101.901.44100.37%～103.43%
2318160317921318040103.32
3312639312389312514101.53
430570930532930551999.26
5313205313313313259101.77
6316416316753316584102.85
20240302211310450310873310662100.93102.511.72100.67%～104.36%
2308459308263308361100.18
3315018314724314871102.29
4319715319856319786103.89
5316896316851316874102.95
6322854322561322708104.84
20240303211310171310707310439100.8599.711.4098.25%～101.16%
2310222310592310407100.84
330183230177230180298.05
4311268311153311210101.11
530289730231930260898.31
630484630510030497399.08
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%
114.816959769481691566947669244693910.27
214.836943369603695180.18
单位质量响应值RSD%判断
4685.424687.660.04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
2024030121162668627056268686.7290.463.3087.33%～93.58%
267830678996786493.88
367169671746717292.93
463692636586367588.09
566657669726681492.43
664134640866411088.69
2024030221162137620876211285.9390.723.3287.56%～93.87%
266460663406640091.86
365049651546510290.06
468645685006857294.86
564640647516469689.50
666553665826656892.09
2024030321164043640636405388.6189.932.7787.32%～92.53%
263290632166325387.50
363490635966354387.91
467712681716794293.99
566138661986616891.54
665059650656506290.01
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%
110.312829772826792830882827122829012828710.07
210.242831972834062833020.06
单位质量响应值RSD%判断
27436.5727666.210.59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
20240301211320161318852319506104.06103.201.76101.30%～105.10%
2321671321352321512104.71
3312273312400312336101.72
4308156308727308442100.46
5316600316635316618103.12
6321881323643322762105.12
20240302211309770310017309894100.93103.331.62101.58%～105.08%
2314488312105313296102.04
3316268315703315986102.91
4321589320802321196104.61
5319733319840319786104.15
6323401323415323408105.33
20240303211309981309984309982100.96100.651.4999.08%～102.22%
2314467314514314490102.43
330456230433930445099.16
4314252314463314358102.38
530549130497730523499.41
630588430555930572299.57
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%
114.816940669250695706939869343693930.17
214.836954869242693950.32
单位质量响应值RSD%判断
4685.554679.370.10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
2024030121169856697976982696.6896.543.0293.48%～99.60%
2727677291172839100.85
369793699156985496.72
468214681296817294.39
570961708037088298.14
667009665436677692.46
2024030221164236641996421888.9295.523.9491.57%～99.46%
268656685986862795.02
369862698166983996.70
4723677283672602100.53
569300693316931695.98
669224693756930095.95
2024030321168890688196885495.3496.221.7494.47%～97.96%
269263689726911895.70
369342690916921695.84
471863718137183899.47
569497694236946096.18
668514683626843894.76
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