氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304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125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991490298148880614912411491768148034114884910.32
210.801464964146226514636140.14
单位质量响应值RSD%判断
135440.49135519.810.05数据可信
长期12月-供试品溶液-2024041521批-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%
240min1226025-22602515.41015.784.5715.4115.784.57
2247032-24703216.84216.84
3226980-22698015.47515.47
4240859-24085916.42116.42
5218286-21828614.88214.88
6229629-22962915.65615.66
480min1429756-42975629.30028.676.1429.3228.706.13
2432370-43237029.47829.50
3406797-40679727.73427.76
4461561-46156131.46831.49
5390289-39028926.60926.63
6402705-40270527.45527.48
720min1590041-59004140.22739.5011.8540.2939.5611.84
2658611-65861144.90244.97
3527301-52730135.95036.01
4663293-66329345.22245.29
5519701-51970135.43235.49
6517335-51733535.27135.34
1440min1915680-91568062.42958.9612.9062.5659.0812.89
2891719-89171960.79560.93
3752676-75267651.31651.43
41050864-105086471.64571.78
5781838-78183853.30453.42
6795658-79565854.24654.36
极限1938453-93845363.98161.3611.9864.2061.5811.97
2940819-94081964.14364.37
3789776-78977653.84554.04
41077918-107791873.49073.74
5813173-81317355.44055.64
6840182-84018257.28157.48
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304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125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991481727148584714805461482758148093814823630.15
210.801471594146892114702580.13
单位质量响应值RSD%判断
134882.89136135.000.66数据可信
长期12月-供试品溶液-2024041721批-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%
240min1230665-23066515.72315.672.6015.7215.672.61
2222832-22283215.18915.19
3232612-23261215.85615.86
4238387-23838716.25016.25
5231715-23171515.79515.79
6223198-22319815.21415.21
480min1402654-40265427.44728.166.9927.4728.186.97
2400401-40040127.29327.32
3398208-39820827.14427.17
4470035-47003532.04032.06
5414588-41458828.26028.28
6392488-39248826.75426.78
720min1531084-53108436.20137.2810.8036.2737.3510.80
2511364-51136434.85734.92
3520929-52092935.50935.57
4666084-66608445.40345.48
5535749-53574936.51936.59
6516437-51643735.20335.27
1440min1788324-78832453.73657.7413.2753.8557.8613.26
2790133-79013353.85953.97
3803246-80324654.75354.87
41072955-107295573.13773.28
5839393-83939357.21757.34
6788662-78866253.75953.87
极限1829395-82939556.53559.9511.7356.7360.1611.72
2819251-81925155.84456.04
3851564-85156458.04658.25
41083348-108334873.84674.10
5881992-88199260.12060.33
6811272-81127255.30055.50
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304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125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991486495148747014811511479607148716814843780.25
210.801457143145138514542640.28
单位质量响应值RSD%判断
135066.24134654.070.22数据可信
长期12月-供试品溶液-2024041821批-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%
240min1194194-19419413.30114.284.2813.3014.284.27
2213689-21368914.63614.64
3210307-21030714.40414.40
4202594-20259413.87613.88
5210126-21012614.39214.39
6219652-21965215.04415.04
480min1362494-36249424.82826.888.6424.8526.908.64
2374223-37422325.63125.65
3370570-37057025.38125.40
4382827-38282726.22026.24
5413283-41328328.30628.33
6451734-45173430.94030.96
720min1482875-48287533.07336.6114.0433.1336.6714.04
2498151-49815134.11934.18
3489183-48918333.50533.56
4508287-50828734.81334.87
5548611-54861137.57537.64
6680215-68021546.58946.66
1440min1726164-72616449.73657.0616.9749.8457.1816.96
2789137-78913754.04954.16
3709104-70910448.56748.68
4805569-80556955.17455.29
5873505-87350559.82759.95
61095363-109536375.02375.16
极限1757498-75749851.88259.4215.8052.0659.6215.79
2808502-80850255.37555.57
3756992-75699251.84752.03
4833433-83343357.08357.28
5936371-93637164.13364.34
61112818-111281876.21876.47
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