依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.484857644850424856394858424861524856880.09
211.384881344880344880840.02
单位质量响应值RSD%判断
42307.3242889.630.97数据可信
供试品溶液-2024041021批-瑞舒伐他汀钙-pH7.0磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1459246-45924692.12690.993.9092.1390.993.91
2458327-45832791.94291.94
3418962-41896284.04584.04
4456562-45656291.58791.59
5470393-47039394.36294.36
6458021-45802191.88091.88
10min1494711-49471199.24098.591.6899.3998.741.68
2492469-49246998.79098.94
3476508-47650895.58995.73
4499201-499201100.141100.29
5497439-49743999.78799.94
6488414-48841497.97798.13
15min1494798-49479899.25899.261.1399.5899.581.13
2494206-49420699.13999.46
3496696-49669699.63899.94
4500770-500770100.456100.78
5497811-49781199.862100.19
6484507-48450797.19397.51
20min1491852-49185298.66799.081.2799.1599.571.27
2491435-49143598.58399.07
3499296-499296100.160100.63
4500556-500556100.413100.90
5496737-49673799.647100.14
6483693-48369397.03097.51
30min1492231-49223198.74398.871.1399.3999.521.13
2489471-48947198.18998.84
3496728-49672899.645100.28
4498439-49843999.988100.64
5496589-49658999.617100.27
6483756-48375697.04397.68
45min1493330-49333098.96398.651.1099.7899.471.10
2489733-48973398.24299.05
3493599-49359999.01799.82
4496701-49670199.639100.46
5495443-49544399.387100.21
6481919-48191996.67497.48
60min1490643-49064398.42498.321.0299.4099.291.02
2487517-48751797.79798.77
3487517-48751797.79798.76
4496544-49654499.608100.59
5495039-49503999.306100.29
6483406-48340696.97297.94
极限1489505-48950598.19698.260.9899.3499.400.98
2486350-48635097.56398.70
3491049-49104998.50699.63
4495458-49545899.390100.54
5494088-49408899.115100.27
6482643-48264396.81997.94
依折麦布瑞舒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ZT-705-231101-1-D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对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.074365774367744367634363354370724367040.07
211.194384004381614382800.04
单位质量响应值RSD%判断
39449.3239167.110.51数据可信
供试品溶液-2024041021批-依折麦布-pH7.0磷酸盐溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1260401-26040159.62251.7622.9559.6251.7622.95
2232108-23210853.14453.14
3135248-13524830.96730.97
4197115-19711545.13245.13
5264406-26440660.53960.54
6267065-26706561.14861.15
10min1436307-43630799.89891.2314.64100.0091.3214.65
2418305-41830595.77695.86
3281787-28178764.51964.57
4401457-40145791.91991.99
5427438-42743897.86797.97
6425400-42540097.40197.50
15min1438796-438796100.46898.612.10100.7398.852.14
2435603-43560399.73799.99
3413054-41305494.57494.73
4432572-43257299.04399.27
5431963-43196398.90399.17
6432079-43207998.93099.19
20min1434501-43450199.48598.720.4299.9299.120.43
2431673-43167398.83799.25
3430832-43083298.64498.96
4430549-43054998.58098.97
5429729-42972998.39298.82
6429727-42972798.39198.82
30min1433457-43345799.24598.260.5099.8498.830.51
2428576-42857698.12898.71
3428784-42878498.17698.66
4428081-42808198.01598.57
5427683-42768397.92398.52
6428413-42841398.09198.68
45min1433345-43334599.22097.840.7699.9898.580.78
2428815-42881598.18398.93
3425414-42541497.40498.05
4425742-42574297.47998.20
5425157-42515797.34598.10
6425566-42556697.43998.20
60min1430959-43095998.67497.740.5199.6098.640.52
2426651-42665197.68798.59
3426651-42665197.68798.49
4425231-42523197.36298.25
5424971-42497197.30398.22
6426901-42690197.74498.66
极限1430154-43015498.48997.450.5799.5898.510.59
2425261-42526197.36998.44
3423442-42344296.95297.92
4424530-42453097.20298.25
5424169-42416997.11998.20
6426225-42622597.59098.67
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