阿齐沙坦左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22012206020对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.4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%
110.884558345635455334552645502455560.12
210.864567245750457110.13
单位质量响应值RSD%判断
4187.134209.120.38数据可信
供试品溶液-24040303批-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%
5min138547-3854776.57075.708.8076.5775.708.80
235273-3527370.06770.07
334413-3441368.35868.36
442099-4209983.62683.63
536332-3633272.17072.17
642001-4200183.43183.43
10min145153-4515389.69289.494.0190.1289.914.02
245499-4549990.38090.77
343738-4373886.88287.26
447104-4710493.56894.03
542249-4224983.92484.32
646555-4655592.47792.94
15min144578-4457888.55090.543.9389.4791.463.95
244936-4493689.26190.15
344585-4458588.56489.43
447659-4765994.67095.65
543720-4372086.84687.71
647998-4799895.34496.32
20min144724-4472488.84089.813.2790.2691.233.30
244723-4472388.83890.23
344322-4432288.04289.40
446966-4696693.29494.80
543460-4346086.32987.68
647080-4708093.52095.03
30min142814-4281485.04689.814.9486.9691.734.91
244262-4426287.92389.80
344264-4426487.92789.77
448330-4833096.00398.03
543945-4394587.29389.12
647655-4765594.66296.69
45min145557-4555790.49591.794.7292.8894.214.70
247005-4700593.37195.74
345492-4549290.36692.70
448454-4845496.25098.81
542566-4256684.55486.87
648176-4817695.69798.25
60min143318-4331886.04790.954.0688.9393.884.02
246625-4662592.61695.50
345353-4535390.09092.92
448842-4884297.020100.12
544835-4483589.06191.84
645749-4574990.87693.96
极限145737-4573790.85293.383.5794.2196.823.59
247310-4731093.97797.38
346483-4648392.33495.67
449421-4942198.170101.81
544843-4484389.07792.36
648262-4826295.86899.46
阿齐沙坦左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(%)99.7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%
111.283926573925073922313921913921193923410.06
211.313935533933523934520.04
单位质量响应值RSD%判断
34782.0034787.980.02数据可信
供试品溶液-24040303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%
5min1170435-17043543.96553.4919.8543.9653.4919.85
2228682-22868258.99058.99
3244379-24437963.03963.04
4156017-15601740.24640.25
5255472-25547265.90165.90
6189250-18925048.81848.82
10min1373294-37329496.29397.931.6296.5498.231.64
2391374-391374100.957101.29
3378053-37805397.52197.87
4378784-37878497.71097.93
5379091-37909197.78998.15
6377241-37724197.31297.58
15min1371740-37174095.89398.281.4596.6799.121.46
2377604-37760497.40598.29
3384568-38456899.202100.09
4381928-38192898.52199.29
5382952-38295298.78599.69
6387110-38711099.857100.67
20min1374252-37425296.54197.260.5297.8598.650.55
2376484-37648497.11698.55
3376477-37647797.11598.56
4376469-37646997.11298.43
5379380-37938097.86399.32
6379276-37927697.83799.20
30min1370626-37062695.60597.420.9997.4599.340.99
2377244-37724497.31299.28
3379125-37912597.79899.78
4379577-37957797.91499.77
5378058-37805897.52299.52
6381283-38128398.354100.26
45min1377406-37740697.35498.121.5499.73100.591.50
2385956-38595699.560102.07
3383459-38345998.916101.44
4380770-38077098.222100.62
5370202-37020295.49698.04
6384468-38446899.176101.63
60min1359052-35905292.62097.342.9895.54100.352.94
2381536-38153698.420101.48
3384158-38415899.096102.17
4384432-38443299.167102.11
5386937-38693799.813102.89
6367903-36790394.90397.91
极限1371376-37137695.79998.171.3199.23101.721.31
2383363-38336398.891102.50
3382057-38205798.554102.18
4385856-38585699.534103.03
5380456-38045698.141101.77
6380224-38022498.081101.62
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