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%
110.662840982839552837122839702836622838790.07
210.712838392837472837930.03
单位质量响应值RSD%判断
26630.3026497.950.36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129235229224529229898.7399.510.7998.69%～100.33%
229544229578729561499.86
3297088297018297053100.34
429233329201029217298.69
529324029334729329499.07
6297353296980297166100.38
6087549批129385329384729385099.26101.781.8199.85%～103.71%
2303905303844303874102.65
3296744297426297085100.35
4307739308043307891104.00
5299352299181299266101.09
6306018305681305850103.31
6087549批129275329251829263698.85101.151.8699.19%～103.11%
2300422299587300004101.34
3298133298783298458100.82
4300957300899300928101.65
529575529569029572299.89
6308678309178308928104.35
6087549批1304751304088304420102.83102.131.27100.77%～103.49%
2299095299165299130101.04
3304127304196304162102.74
4296345296391296368100.11
5306544306652306598103.57
6303316303532303424102.49
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%
114.786937669369693166930769294693320.06
214.796979169583696870.22
单位质量响应值RSD%判断
4690.934711.760.32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166641664786656091.7992.231.4990.80%～93.67%
267666675576761293.24
367327674526739092.93
465447657306558890.45
568083682036814393.97
666111658896600091.02
6087549批168116680186806793.8794.292.2792.05%～96.54%
267697676026765093.29
366268662916628091.40
470223701137016896.77
567908677856784693.56
670272702097024096.87
6087549批167228673306727992.7892.821.3691.49%～94.14%
267250671726721192.69
367065671936712992.57
467341672456729392.80
565993660596602691.05
668770690066888895.00
6087549批166484665166650091.7190.203.3487.05%～93.35%
262896629126290486.75
365051650906507089.74
462830628906286086.69
567170669136704292.45
668074680546806493.86
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%
110.662839722839382840052839462840782839880.03
210.712840242836922838580.09
单位质量响应值RSD%判断
26640.5326504.010.37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1297201297168297184100.35100.430.8599.54%～101.32%
2297466297772297619100.50
3300979300719300849101.59
429429029410629419899.35
529503129515629509499.65
6299253299632299442101.12
6087549批1297234297183297208100.36102.491.37101.02%～103.96%
2307360307099307230103.75
3300303300892300598101.51
4307842308392308117104.05
5302812303071302942102.30
6304871305051304961102.98
6087549批129341129415129378199.21101.811.59100.12%～103.50%
2300431300542300486101.47
3299401299665299533101.15
4303024303278303151102.37
5306413302181304297102.76
6307559307918307738103.92
6087549批1310284309950310117104.72102.661.35101.22%～104.11%
2297930298787298358100.75
3304364303714304039102.67
4301848301951301900101.95
5307000306853306926103.64
6302707302932302820102.26
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%
114.786947769290698146977869584695890.32
214.796960869326694670.29
单位质量响应值RSD%判断
4708.324696.890.18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169285695416941395.7095.781.8893.89%～97.67%
270699710007085097.68
369772699546986396.32
468042680486804593.81
571041705837081297.63
667801679136785793.55
6087549批170440703837041297.0897.971.6096.33%～99.61%
271469718677166898.81
369267689566911295.28
471777721627197099.22
572175719347205499.34
671125711437113498.07
6087549批170087702007014496.7196.300.3195.99%～96.61%
269842694896966696.05
369922700056996496.46
469574699336975496.17
569994699666998096.48
669449697086957895.93
6087549批169054692156913495.3193.312.4290.95%～95.67%
265553654646550890.32
367894678146785493.55
465688659256580690.73
568808686856874694.78
668988690906903995.18
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