阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.124895248649486134867748677487140.28
211.254858748568485780.03
单位质量响应值RSD%判断
4380.764318.041.02数据可信
供试品溶液-24050702批-苯磺酸左氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125205-2520546.83645.7410.3346.8445.7410.32
224937-2493746.33846.34
321380-2138039.72839.73
425611-2561147.59147.59
522164-2216441.18541.19
628405-2840552.78252.78
10min143159-4315980.19881.551.6480.4681.811.64
244715-4471583.09083.35
344595-4459582.86783.09
443702-4370281.20781.47
543014-4301479.92980.16
644144-4414482.02982.32
15min145752-4575285.01785.371.9485.7286.081.92
247549-4754988.35689.07
346309-4630986.05286.73
445563-4556384.66585.38
545426-4542684.41185.08
645054-4505483.72084.47
20min146105-4610585.67385.821.4986.8587.001.49
247566-4756688.38789.60
345814-4581485.13286.29
445952-4595285.38886.57
545841-4584185.18286.32
645836-4583685.17386.39
30min145596-4559684.72786.092.0986.3887.742.06
248075-4807589.33391.03
346837-4683787.03388.66
445973-4597385.42787.09
545753-4575385.01886.63
645736-4573684.98786.67
45min145695-4569584.91185.503.4787.0487.643.40
248389-4838989.91792.11
346765-4676586.89989.01
443516-4351680.86283.00
546064-4606485.59687.68
645640-4564084.80986.97
60min145580-4558084.69785.273.9387.2987.883.85
248565-4856590.24492.94
347008-4700887.35189.95
443168-4316880.21582.80
545481-4548184.51387.08
645523-4552384.59187.22
极限146398-4639886.21787.753.3489.2890.843.26
248723-4872390.53793.74
349683-4968392.32195.40
446461-4646186.33489.36
545950-4595085.38588.42
646132-4613285.72388.82
阿齐沙坦片项目信息
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%
110.843874153860763857563862003858243862540.18
210.963837573839643838600.04
单位质量响应值RSD%判断
35632.2935023.721.22数据可信
供试品溶液-24050702批-阿齐沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142715-4271510.85011.0923.0710.8511.0923.09
249890-4989012.67312.67
325135-251356.3856.38
447238-4723811.99912.00
554204-5420413.76813.77
642842-4284210.88210.88
10min1256020-25602065.03257.5110.5265.0957.5710.52
2208469-20846952.95353.02
3198459-19845950.41150.45
4228753-22875358.10658.17
5252738-25273864.19864.27
6214025-21402554.36454.42
15min1321457-32145781.65384.943.1982.0785.323.19
2346988-34698888.13888.50
3329080-32908083.59083.91
4339786-33978686.30986.70
5344182-34418287.42687.86
6324922-32492282.53382.90
20min1333043-33304384.59689.744.2485.4790.604.22
2376335-37633595.59396.45
3350252-35025288.96889.75
4355379-35537990.27091.14
5361487-36148791.82192.74
6343327-34332787.20888.03
30min1342728-34272887.05693.335.9988.4094.695.92
2408752-408752103.827105.21
3367257-36725793.28794.56
4362263-36226392.01893.39
5364104-36410492.48693.92
6359574-35957491.33592.64
45min1345766-34576687.82893.835.8089.6695.705.72
2409710-409710104.070106.03
3368807-36880793.68195.47
4360713-36071391.62593.51
5365400-36540092.81594.76
6365915-36591592.94694.76
60min1345253-34525387.69893.256.6790.0195.646.58
2411146-411146104.435106.98
3370460-37046094.10196.41
4343404-34340487.22889.62
5367645-36764593.38595.84
6364794-36479492.66194.99
极限1375395-37539595.35499.704.9998.16102.614.88
2413981-413981105.155108.28
3418648-418648106.341109.18
4385509-38550997.923100.80
5372079-37207994.51297.49
6389368-38936898.903101.75
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