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%
115.089494694888948259508194635948750.18
215.049527995261952700.02
单位质量响应值RSD%判断
6291.456334.440.49数据可信
供试品溶液-24111101批-氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179344-7934481.47685.513.0581.4885.513.05
286768-8676889.10089.10
382328-8232884.54084.54
484306-8430686.57186.57
584583-8458386.85686.86
682316-8231684.52884.53
10min188392-8839290.76794.262.7890.9094.402.78
295449-9544998.01498.16
390088-9008892.50992.65
492897-9289795.39395.54
593248-9324895.75495.90
690661-9066193.09793.24
15min191764-9176494.23097.062.5794.5297.362.57
297747-97747100.374100.69
392152-9215294.62894.92
496223-9622398.80999.11
595820-9582098.39598.70
693424-9342495.93596.23
20min192415-9241594.89897.952.6095.3498.412.60
298772-98772101.426101.91
392828-9282895.32295.78
496552-9655299.14799.61
596889-9688999.49399.96
694863-9486397.41297.87
30min193119-9311995.62198.182.7596.2298.812.75
299563-99563102.238102.89
392453-9245394.93795.55
496875-9687599.478100.11
596546-9654699.14099.77
695132-9513297.68898.31
45min193540-9354096.05498.622.3396.8299.412.34
299124-99124101.788102.61
393804-9380496.32597.09
497526-97526100.147100.95
597125-9712599.735100.53
695100-9510097.65698.44
极限193133-9313395.63698.452.5096.5699.402.50
299292-99292101.960102.95
393319-9331995.82796.76
496934-9693499.539100.50
597132-9713299.742100.71
695442-9544298.00798.95
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%
1 11.413542993536843535683545713530393538320.18
2 11.483559453557213558330.05
单位质量响应值RSD%判断
31010.6930995.910.04数据可信
供试品溶液-24111101批-阿托伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1188588-18858850.24451.552.3750.2451.552.37
2196518-19651852.35752.36
3196373-19637352.31852.32
4192134-19213451.18951.19
5199196-19919653.07053.07
6188163-18816350.13150.13
10min1274911-27491173.24373.021.4573.3373.101.45
2275814-27581473.48373.57
3270099-27009971.96172.05
4272610-27261072.63072.71
5280627-28062774.76674.85
6270351-27035172.02872.11
15min1318818-31881884.94183.612.3285.1583.812.31
2311814-31181483.07583.28
3301292-30129280.27180.48
4316752-31675284.39084.60
5321962-32196285.77885.99
6312194-31219483.17683.38
20min1338948-33894890.30489.062.7090.6589.412.69
2332553-33255388.60088.95
3317416-31741684.56784.91
4337470-33747089.91090.26
5343453-34345391.50491.86
6335879-33587989.48689.83
30min1357767-35776795.31793.783.0595.8294.273.05
2351361-35136193.61194.11
3330863-33086388.15088.63
4358132-35813295.41595.91
5359080-35908095.66796.18
6354703-35470394.50194.99
45min1369575-36957598.46396.482.4899.1297.132.48
2358022-35802295.38596.04
3346180-34618092.23092.86
4367849-36784998.00498.66
5368739-36873998.24198.91
6362411-36241196.55597.20
极限1374042-37404299.65498.141.71100.4798.961.71
2365720-36572097.43698.25
3359931-35993195.89496.68
4368175-36817598.09098.91
5377184-377184100.491101.32
6365222-36522297.30498.11
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%
115.089566895665958829567296056957890.19
215.049588095558957190.24
单位质量响应值RSD%判断
6352.066364.300.14数据可信
供试品溶液-24111102批-氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183085-8308584.71086.981.8384.7186.981.83
285168-8516886.83486.83
387728-8772889.44489.44
485883-8588387.56387.56
584385-8438586.03586.04
685620-8562087.29487.29
10min191355-9135593.14295.051.7193.2895.201.71
293387-9338795.21395.36
395978-9597897.85598.00
493596-9359695.42695.57
592094-9209493.89594.04
692970-9297094.78894.93
15min193321-9332195.14696.991.8695.4497.291.86
294058-9405895.89796.20
398024-9802499.941100.25
496463-9646398.34998.65
594647-9464796.49896.80
694277-9427796.12196.42
20min194103-9410395.94397.901.5996.4098.371.59
295730-9573097.60298.07
398513-98513100.440100.92
496665-9666598.55599.02
594951-9495196.80897.27
696183-9618398.06498.53
30min194550-9455096.39998.511.6797.0199.141.67
296088-9608897.96798.59
398899-98899100.833101.48
497360-9736099.26499.90
595281-9528197.14497.77
697529-9752999.436100.06
45min194518-9451896.36698.481.9297.1499.271.91
296072-9607297.95198.74
399404-99404101.348102.16
496930-9693098.82699.62
594842-9484296.69797.48
697771-9777199.683100.48
极限194510-9451096.35897.232.0597.2998.182.03
296054-9605497.93298.88
392246-9224694.05095.03
497547-9754799.455100.42
594732-9473296.58597.53
697092-9709298.99199.95
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%
1 11.413565633565923576683568593581203571600.20
2 11.483579953565593572770.29
单位质量响应值RSD%判断
31302.3731121.690.41数据可信
供试品溶液-24111102批-阿托伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1202081-20208153.47952.452.0453.4852.462.04
2199025-19902552.67152.67
3196326-19632651.95651.96
4198552-19855252.54652.55
5201957-20195753.44753.45
6191258-19125850.61550.62
10min1289499-28949976.61474.903.0376.7074.983.03
2283637-28363775.06375.15
3281782-28178274.57274.66
4288359-28835976.31276.40
5288110-28811076.24776.34
6266629-26662970.56270.65
15min1328877-32887787.03585.303.2787.2585.513.27
2313967-31396783.08983.30
3321518-32151885.08885.30
4333004-33300488.12788.34
5330399-33039987.43887.65
6306184-30618481.03081.23
20min1349433-34943392.47590.213.4792.8490.563.46
2332767-33276788.06588.42
3339547-33954789.85990.21
4351613-35161393.05293.41
5349873-34987392.59292.95
6321936-32193685.19885.54
30min1370324-37032498.00495.073.6498.5295.573.63
2345398-34539891.40791.91
3356755-35675594.41394.92
4373386-37338698.81499.33
5366787-36678797.06897.58
6342674-34267490.68791.17
45min1380948-380948100.81697.263.37101.4997.923.36
2351132-35113292.92593.58
3367276-36727697.19797.86
4378975-378975100.293100.97
5372020-37202098.45399.13
6354710-35471093.87294.50
极限1383742-383742101.55598.233.17102.4099.063.16
2366792-36679297.06997.87
3354420-35442093.79594.62
4384619-384619101.787102.64
5373226-37322698.77299.61
6364281-36428196.40597.19
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