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%
110.991492402148369014897451487985148886514885370.22
210.801463289145397914586340.46
单位质量响应值RSD%判断
135444.68135058.700.21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%
240min1237679-23767916.23215.469.1916.2315.469.20
2241076-24107616.46416.46
3233716-23371615.96115.96
4232516-23251615.87915.88
5184858-18485812.62412.62
6228184-22818415.58315.58
480min1471359-47135932.19028.1511.9532.2128.1711.94
2426362-42636229.11729.14
3442172-44217230.19730.22
4414341-41434128.29628.32
5328296-32829622.42022.44
6390300-39030026.65526.68
720min1652558-65255844.56537.3613.3344.6437.4213.32
2552371-55237137.72337.79
3598820-59882040.89540.96
4536202-53620236.61936.68
5447912-44791230.58930.64
6494452-49445233.76733.83
1440min11073221-107322173.29355.5117.9173.4355.6317.89
2799307-79930754.58754.71
3876563-87656359.86359.99
4742547-74254750.71150.83
5694259-69425947.41347.51
6690963-69096347.18847.30
极限11125665-112566576.87557.8617.7477.1258.0617.72
2833127-83312756.89757.10
3894009-89400961.05461.27
4763938-76393852.17152.37
5742815-74281550.72950.90
6724062-72406249.44849.63
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%
110.991470510147166414654841465416146363714673420.24
210.801454113144859114513520.27
单位质量响应值RSD%判断
133516.11134384.440.46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%
240min1230696-23069615.90815.846.3715.9115.846.39
2223728-22372815.42815.43
3217271-21727114.98214.98
4233608-23360816.10916.11
5216727-21672714.94514.94
6256035-25603517.65517.66
480min1393932-39393227.16427.592.9627.1927.612.95
2382737-38273726.39226.42
3407874-40787428.12628.15
4393858-39385827.15927.18
5408221-40822128.15028.17
6413978-41397828.54728.57
720min1519805-51980535.84436.552.5935.9136.622.59
2516400-51640035.60935.67
3534789-53478936.87736.94
4519942-51994235.85435.92
5551389-55138938.02238.09
6538182-53818237.11137.18
1440min1815319-81531956.22256.773.0156.3456.893.00
2794928-79492854.81654.93
3823194-82319456.76556.88
4854368-85436858.91559.03
5850622-85062258.65658.78
6801400-80140055.26255.39
极限1851827-85182758.73959.113.4558.9459.323.44
2825893-82589356.95157.15
3858695-85869559.21359.42
4896922-89692261.84962.06
5884572-88457260.99761.21
6825375-82537556.91557.12
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%
110.991471854147117814675551463724146497814678580.25
210.801452451145500714537290.13
单位质量响应值RSD%判断
133563.06134604.540.55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%
240min1203687-20368714.03213.852.5714.0313.842.58
2192247-19224713.24413.24
3206097-20609714.19814.20
4202731-20273113.96613.97
5203717-20371714.03414.03
6197465-19746513.60313.60
480min1367845-36784525.34025.573.0125.3625.593.00
2351089-35108924.18624.21
3370595-37059525.53025.55
4376746-37674625.95325.97
5380309-38030926.19926.22
6380732-38073226.22826.25
720min1512446-51244635.30234.762.2335.3634.822.23
2488202-48820233.63133.69
3496520-49652034.20534.26
4500681-50068134.49134.55
5516771-51677135.60035.66
6513063-51306335.34435.40
1440min1830313-83031357.19955.876.4157.3155.986.39
2781844-78184453.86053.97
3790323-79032354.44454.56
4906717-90671762.46262.57
5795432-79543254.79654.91
6761657-76165752.46952.58
极限1870787-87078759.98759.095.5860.1859.285.57
2844075-84407558.14758.33
3841915-84191557.99858.19
4945864-94586465.15965.36
5838416-83841657.75757.95
6805706-80570655.50455.70
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