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)0
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%
110.782903712902352906862903762908792905090.10
210.762907402904812906100.07
单位质量响应值RSD%判断
26948.8927008.360.16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
1批130024230027730026099.8799.981.2498.68%～101.27%
2305700305777305738101.69
329684429658829671698.69
4300955300923300939100.09
5303271303917303594100.97
629614829646529630698.55
1批130024329980930002699.7999.801.1698.59%～101.01%
229525029518529521898.19
3304986305350305168101.50
430401429645030023299.86
529773529742129757898.97
6302667301593302130100.49
1批1310483311149310816103.38104.220.62103.55%～104.90%
2312804313579313192104.17
3315111314665314888104.73
4313904313854313879104.40
5315607316088315848105.05
6312031310972311502103.60
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)0
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(%) 99.90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%
115.447453174798745347478674766746830.19
215.547486174735747980.12
单位质量响应值RSD%判断
4836.984813.260.35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
1批168288685636842691.9493.421.9691.50%～95.33%
271842719527189796.61
368939689516894592.64
470195704267031094.47
568372683896838091.88
669082692966918992.97
1批165373656686552088.0490.862.9788.03%～93.68%
264929649276492887.24
369559696386959893.52
467927674626769490.96
568479681836833191.82
669658695856962293.55
1批164476644216444886.6096.415.1691.20%～101.62%
273019726557283797.87
374054742667416099.65
473195735767338698.61
571638715747160696.22
674062740527405799.51
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