氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399442994501944849362594497943070.41
215.459360093602936010.01
单位质量响应值RSD%判断
6127.816058.320.81数据可信
供试品溶液-LA6362批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min153357-5335756.76962.389.2156.7762.389.21
267644-6764471.97071.97
362498-6249866.49566.49
456976-5697660.62060.62
554869-5486958.37858.38
656437-5643760.04660.05
10min185645-8564591.12290.292.0891.2290.402.09
286210-8621091.72391.84
386963-8696392.52492.64
482631-8263187.91588.02
582942-8294288.24688.34
684788-8478890.21090.31
15min191773-9177397.64297.010.9597.8997.260.95
290795-9079596.60196.87
392141-9214198.03498.30
489836-8983695.58195.83
590754-9075496.55896.80
691751-9175197.61997.87
20min192737-9273798.66897.970.8199.0898.380.81
291786-9178697.65698.09
391184-9118497.01597.44
491344-9134497.18697.59
592458-9245898.37198.78
692957-9295798.90299.31
30min193481-9348199.45998.740.83100.0399.320.83
292414-9241498.32498.92
393428-9342899.40399.99
492979-9297998.92599.49
591453-9145397.30297.87
693098-9309899.05299.63
45min193187-9318799.14698.430.6599.8999.180.64
291505-9150597.35798.12
392476-9247698.39099.15
492388-9238898.29699.03
592461-9246198.37499.11
693059-9305999.01099.75
极限192809-9280998.74498.070.9499.6598.980.94
291162-9116296.99297.91
392678-9267898.60599.52
491031-9103196.85397.75
592364-9236498.27199.17
693023-9302398.97299.88
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.333513133514943517183508183521443514970.14
211.303495913496593496250.02
单位质量响应值RSD%判断
31023.5730940.270.20数据可信
供试品溶液-LA6362批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133567-335678.94910.229.738.9510.229.74
244732-4473211.92611.93
339587-3958710.55410.55
438336-3833610.22110.22
537049-370499.8789.88
636736-367369.7949.79
10min193827-9382725.01524.484.2925.0324.494.29
295953-9595325.58225.60
395313-9531325.41125.43
489047-8904723.74123.76
585880-8588022.89622.91
690817-9081724.21324.23
15min1129737-12973734.58934.273.3134.6534.323.32
2132757-13275735.39435.46
3132624-13262435.35935.42
4123747-12374732.99233.05
5122984-12298432.78832.84
6129301-12930134.47334.53
20min1150316-15031640.07539.722.7640.1939.842.75
2153453-15345340.91241.03
3144276-14427638.46538.58
4145077-14507738.67938.79
5147234-14723439.25439.36
6153644-15364440.96341.08
30min1169553-16955345.20445.371.6845.3945.551.68
2174099-17409946.41646.61
3169778-16977845.26445.45
4166183-16618344.30644.48
5168639-16863944.96045.14
6172694-17269446.04246.22
45min1183116-18311648.82048.762.5149.0849.022.51
2187242-18724249.92050.19
3180987-18098748.25348.51
4179947-17994747.97548.23
5176962-17696247.17947.43
6189126-18912650.42250.68
极限1204676-20467654.56854.412.0454.9154.752.04
2205485-20548554.78455.13
3204368-20436854.48654.82
4200004-20000453.32353.65
5199315-19931553.13953.47
6210742-21074256.18556.53
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