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%
112.455177651739518045187351885518150.13
212.435199652047520220.07
单位质量响应值RSD%判断
4161.854185.200.40数据可信
供试品溶液-2024052421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%
5min144069-4406985.33685.462.5485.3485.462.54
242613-4261382.51782.52
344595-4459586.35586.35
444773-4477386.70086.70
545644-4564488.38688.39
643115-4311583.48983.49
10min150353-5035397.50593.153.8297.9893.623.80
248168-4816893.27493.73
345896-4589688.87489.35
448561-4856194.03594.52
549622-4962296.08996.58
646014-4601489.10389.57
15min151127-5112799.00494.753.44100.0295.743.43
248073-4807393.09094.07
349256-4925695.38196.35
448617-4861794.14395.15
550181-5018197.17298.20
646318-4631889.69190.65
20min150281-5028197.36694.323.1698.9395.843.15
247426-4742691.83793.33
349525-4952595.90297.40
448434-4843493.78995.32
550107-5010797.02998.59
646474-4647489.99491.45
30min150409-5040997.61394.433.3099.7296.473.28
247804-4780492.56994.57
349918-4991896.66398.70
448022-4802292.99195.04
550052-5005296.92299.03
646371-4637189.79491.75
45min150193-5019397.19594.482.6399.8497.052.64
247940-4794092.83295.35
349480-4948095.81498.39
448522-4852293.95996.52
549815-4981596.46399.11
646810-4681090.64493.10
60min150546-5054697.87993.743.28101.0796.833.26
248151-4815193.24196.27
348952-4895294.79297.90
447425-4742591.83594.92
549372-4937295.60598.78
646007-4600789.08992.05
极限151930-51930100.55998.181.82104.29101.791.86
249839-4983996.510100.06
350665-5066598.109101.74
450883-5088398.531102.13
551402-5140299.536103.25
649493-4949395.84099.29
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(%)99.70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%
111.053912863906813910053909873904673908850.09
211.153924513927683926100.06
单位质量响应值RSD%判断
35374.2135211.660.33数据可信
供试品溶液-2024052421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%
5min1130096-13009633.07634.695.8633.0834.695.86
2144368-14436836.70536.70
3147955-14795537.61737.62
4127941-12794132.52832.53
5134744-13474434.25834.26
6133496-13349633.94133.94
10min1313383-31338379.67679.260.7579.8679.450.75
2311786-31178679.27079.47
3314048-31404879.84580.05
4307513-30751378.18478.36
5312463-31246379.44279.63
6311232-31123279.12979.32
15min1339225-33922586.24685.812.5986.8786.442.57
2326931-32693183.12183.76
3344672-34467287.63188.28
4328005-32800583.39484.01
5348595-34859588.62889.26
6337688-33768885.85586.48
20min1341159-34115986.73886.943.0787.8488.043.05
2329544-32954483.78584.89
3349107-34910788.75989.90
4330126-33012683.93385.01
5355604-35560490.41091.53
6346064-34606487.98589.09
30min1344005-34400587.46288.313.2989.0589.903.26
2332249-33224984.47386.04
3354527-35452790.13791.77
4336792-33679285.62887.17
5360657-36065791.69593.32
6355797-35579790.46092.05
45min1348807-34880788.68289.493.0390.7691.573.01
2339509-33950986.31888.36
3356000-35600090.51192.64
4340794-34079486.64588.67
5364005-36400592.54694.68
6362764-36276492.23194.33
60min1354396-35439690.10390.073.0892.6792.653.05
2341766-34176686.89289.41
3356481-35648190.63393.27
4341528-34152886.83289.33
5363864-36386492.51195.16
6367543-36754393.44696.05
极限1395507-395507100.556100.252.28103.62103.332.23
2390735-39073599.342102.35
3382503-38250397.249100.39
4389268-38926898.969101.95
5399646-399646101.608104.77
6408207-408207103.785106.91
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