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%
110.991478807147730414870651485999147929314816940.31
210.801464633145769914611660.34
单位质量响应值RSD%判断
134822.02135293.150.25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%
240min1242489-24248916.58417.239.0516.5817.239.06
2239158-23915816.35616.36
3297774-29777420.36520.37
4247460-24746016.92416.92
5246647-24664716.86816.87
6237971-23797116.27516.28
480min1436662-43666229.86428.556.1629.8928.586.17
2390519-39051926.70826.73
3457604-45760431.29631.33
4394263-39426326.96426.99
5409785-40978528.02628.05
6416192-41619228.46428.49
720min1608805-60880541.63736.997.0041.7137.066.99
2512330-51233035.03935.10
3560645-56064538.34338.42
4513414-51341435.11335.18
5531566-53156636.35436.42
6518777-51877735.48035.55
1440min1818627-81862755.98754.024.2056.1254.154.19
2773683-77368352.91353.03
3802707-80270754.89855.03
4762880-76288052.17452.29
5832622-83262256.94457.07
6749019-74901951.22651.35
极限1855199-85519958.48856.623.4258.7056.833.42
2802283-80228354.86955.07
3853626-85362658.38058.60
4807580-80758055.23155.43
5851687-85168758.24858.45
6797030-79703054.51054.71
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%
110.991464786146971614714241472080146839314692800.20
210.801462710145680814597590.29
单位质量响应值RSD%判断
133692.45135162.870.78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%
240min1245628-24562816.87816.324.9916.8816.325.00
2234215-23421516.09416.09
3233905-23390516.07216.07
4256228-25622817.60617.61
5221925-22192515.24915.25
6233343-23334316.03416.03
480min1404384-40438427.78727.103.9227.8127.133.91
2401325-40132527.57627.60
3380923-38092326.17426.20
4408620-40862028.07828.10
5369719-36971925.40525.43
6401617-40161727.59627.62
720min1510498-51049835.07835.182.3335.1435.242.34
2524546-52454636.04336.11
3510088-51008835.05035.11
4519129-51912935.67135.74
5490291-49029133.69033.75
6517111-51711135.53235.60
1440min1723761-72376149.73252.573.0149.8552.693.00
2774320-77432053.20653.33
3755676-75567651.92552.04
4789681-78968154.26254.38
5774508-77450853.21953.33
6772841-77284153.10453.22
极限1753140-75314051.75154.773.6651.9454.973.65
2821408-82140856.44256.64
3781537-78153753.70253.90
4834210-83421057.32157.52
5789261-78926154.23354.42
6803224-80322455.19255.39
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%
110.991488660148365914859641482344149389914869050.31
210.801467569146677214671700.04
单位质量响应值RSD%判断
135296.18135849.070.29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%
240min1236987-23698716.14616.393.6616.1516.393.66
2251911-25191117.16317.16
3249025-24902516.96616.97
4240956-24095616.41716.42
5235876-23587616.07116.07
6228260-22826015.55215.55
480min1406578-40657827.70127.474.2427.7227.504.24
2427711-42771129.14029.17
3414591-41459128.24728.27
4395818-39581826.96826.99
5396060-39606026.98427.01
6378476-37847625.78625.81
720min1541085-54108536.86536.293.9336.9336.363.93
2559980-55998038.15238.22
3533345-53334536.33736.41
4536547-53654736.55636.62
5528952-52895236.03836.10
6496045-49604533.79633.86
1440min1861701-86170158.70956.244.2958.8356.364.28
2861169-86116958.67258.80
3805182-80518254.85854.98
4845016-84501657.57257.69
5802162-80216254.65254.77
6777261-77726152.95653.07
极限1921555-92155562.78758.754.9463.0058.954.94
2892603-89260360.81461.03
3814735-81473555.50955.71
4881109-88110960.03160.24
5840846-84084657.28857.49
6822740-82274056.05456.25
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