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%
111.042930492932432933892928192928752930750.09
211.202932912931832932370.03
单位质量响应值RSD%判断
26546.6526181.880.98数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min190289-9028930.73119.1574.3130.7319.1574.31
292672-9267231.54231.54
399912-9991234.00634.01
418640-186406.3446.34
521210-212107.2197.22
614925-149255.0805.08
10min1171604-17160458.40841.6944.2858.5841.7944.35
2167583-16758357.03957.21
3176139-17613959.95160.14
472380-7238024.63624.67
580051-8005127.24627.29
667119-6711922.84522.87
15min1209085-20908571.16558.7123.6971.6659.0423.87
2204293-20429369.53470.03
3213899-21389972.80373.33
4139924-13992447.62547.80
5144638-14463849.22949.42
6123033-12303341.87642.03
20min1231924-23192478.93871.9111.1879.8372.5711.43
2225997-22599776.92177.80
3238584-23858481.20582.13
4192118-19211865.39065.83
5195962-19596266.69867.16
6183043-18304362.30162.69
30min1255980-25598087.12684.144.6288.4685.204.90
2250357-25035785.21286.52
3263794-26379489.78691.16
4238135-23813581.05281.85
5240412-24041281.82782.66
6234562-23456279.83680.57
45min1277313-27731394.38793.293.1596.2094.823.37
2271812-27181292.51594.29
3289849-28984998.654100.53
4270671-27067192.12693.38
5269293-26929391.65792.95
6265579-26557990.39391.57
60min1287297-28729797.78597.062.94100.1299.113.15
2282174-28217496.04298.33
3301074-301074102.475104.90
4281075-28107595.66897.43
5281540-28154095.82697.63
6277790-27779094.55096.23
极限1291443-29144399.19799.182.50102.08101.772.68
2288020-28802098.031100.86
3305852-305852104.101107.09
4287741-28774197.937100.23
5288941-28894198.345100.68
6286450-28645097.49799.70
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%
114.947088470200706247008170987705550.58
215.077047170407704390.07
单位质量响应值RSD%判断
4722.564674.120.73数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159388-5938881.95481.203.0981.9581.203.09
259184-5918481.67281.67
356848-5684878.44978.45
461969-6196985.51685.52
557509-5750979.36179.36
658145-5814580.23980.24
10min172885-72885100.57997.233.19101.0397.683.19
271020-7102098.00698.46
367655-6765593.36293.80
473112-73112100.893101.37
568827-6882794.97995.42
669249-6924995.56296.01
15min174496-74496102.80299.634.02103.82100.624.00
273140-73140100.931101.93
367519-6751993.17494.13
475631-75631104.369105.40
570973-7097397.94198.91
671434-7143498.57799.55
20min175988-75988104.861101.263.46106.45102.813.45
273526-73526101.464103.02
369731-6973196.22797.70
476462-76462105.516107.13
572437-7243799.961101.47
672138-7213899.549101.07
30min176036-76036104.928101.133.85107.10103.243.84
273177-73177100.982103.10
368654-6865494.74196.75
476422-76422105.460107.66
573005-73005100.745102.81
672431-7243199.953102.03
45min176917-76917106.143102.793.54108.89105.463.53
275060-75060103.581106.26
370735-7073597.612100.15
477771-77771107.322110.11
573578-73578101.536104.16
672846-72846100.526103.16
60min176865-76865106.072102.453.51109.41105.693.51
275437-75437104.101107.36
370502-7050297.291100.37
476863-76863106.069109.45
573644-73644101.627104.82
672144-7214499.557102.75
极限176274-76274105.256103.043.72109.19106.853.70
275384-75384104.028107.87
370126-7012696.772100.39
478058-78058107.718111.69
575199-75199103.773107.53
672946-72946100.664104.41
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