氟伐他汀缓释片项目信息
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%
110.991485477147848014669151474353147570114761850.46
210.801479545148145814805020.10
单位质量响应值RSD%判断
134320.75137083.521.44数据可信
中间条件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%
240min1251362-25136217.11116.165.0217.1116.165.03
2248507-24850716.91716.92
3225414-22541415.34515.34
4242381-24238116.50016.50
5234175-23417515.94115.94
6222884-22288415.17215.17
480min1415383-41538328.27627.164.7228.3027.184.72
2409178-40917827.85427.88
3388475-38847526.44526.47
4410898-41089827.97128.00
5404386-40438627.52827.55
6365530-36553024.88324.91
720min1521629-52162935.50934.763.5135.5834.823.51
2537004-53700436.55536.62
3508497-50849734.61534.68
4505544-50554434.41434.48
5507385-50738534.53934.60
6483277-48327732.89832.96
1440min1801133-80113354.53552.315.4954.6652.425.49
2827626-82762656.33956.46
3781371-78137153.19053.30
4735476-73547650.06650.18
5747632-74763250.89451.01
6717125-71712548.81748.93
极限1842302-84230257.33855.245.1657.5455.435.16
2862808-86280858.73458.94
3836590-83659056.94957.14
4770240-77024052.43352.63
5796076-79607654.19154.38
6760437-76043751.76551.95
氟伐他汀缓释片项目信息
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%
110.991464549146816714696241473800146655414685390.24
210.801459507144972214546140.48
单位质量响应值RSD%判断
133625.02134686.480.56数据可信
中间条件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%
240min1253622-25362217.46218.4410.1417.4618.4410.14
2252133-25213317.36017.36
3252330-25233017.37317.37
4303738-30373820.91320.91
5301216-30121620.73920.74
6243573-24357316.77016.77
480min1405508-40550827.92029.308.3327.9529.328.33
2398470-39847027.43527.46
3401656-40165627.65527.68
4465560-46556032.05532.09
5476180-47618032.78632.82
6405517-40551727.92027.95
720min1523570-52357036.04937.325.6836.1237.395.69
2518779-51877935.71935.79
3514762-51476235.44235.51
4575487-57548739.62339.70
5585873-58587340.33840.42
6533614-53361436.74036.81
1440min1756210-75621052.06654.203.4352.1954.323.44
2768942-76894252.94353.06
3765326-76532652.69452.81
4822079-82207956.60156.74
5804341-80434155.38055.52
6806075-80607555.50055.62
极限1797875-79787554.93556.603.2555.1456.813.25
2800843-80084355.13955.34
3800499-80049955.11655.32
4862848-86284859.40859.63
5839779-83977957.82058.04
6830909-83090957.20957.41
氟伐他汀缓释片项目信息
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%
110.991470518146723814686271466415146516314675920.15
210.801454721144579814502600.44
单位质量响应值RSD%判断
133538.85134283.330.40数据可信
中间条件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%
240min1224172-22417215.46315.802.4515.4615.802.44
2222184-22218415.32615.33
3236088-23608816.28516.28
4226798-22679815.64415.64
5234278-23427816.16016.16
6231023-23102315.93515.94
480min1379458-37945826.17427.132.3026.2027.162.30
2397129-39712927.39327.42
3400988-40098827.65927.68
4391042-39104226.97327.00
5403713-40371327.84727.87
6387809-38780926.75026.77
720min1497389-49738934.30835.743.1634.3735.803.15
2507376-50737634.99735.06
3544330-54433037.54637.61
4513806-51380635.44135.50
5527173-52717336.36336.43
6518694-51869435.77835.84
1440min1803344-80334455.41255.593.3955.5355.713.38
2804136-80413655.46755.58
3840038-84003857.94358.07
4780105-78010553.80953.93
5834486-83448657.56057.68
6773419-77341953.34853.47
极限1846888-84688858.41658.103.1658.6158.303.16
2853817-85381758.89459.09
3858019-85801959.18359.39
4812489-81248956.04356.24
5874667-87466760.33260.54
6807723-80772355.71455.91
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