氟伐他汀钠片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
111.031458661145784314587561457184145739014579670.05
210.941429280142997614296280.04
单位质量响应值RSD%判断
132181.96130678.980.81数据可信
供试品溶液-23113001批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1234001-23400115.78715.846.6515.7915.846.64
2222720-22272015.02515.03
3224874-22487415.17115.17
4261791-26179117.66117.66
5243553-24355316.43116.43
6221872-22187214.96814.97
480min1433134-43313429.22129.686.8529.2429.716.85
2417015-41701528.13328.16
3428190-42819028.88728.91
4499411-49941133.69233.72
5439332-43933229.63929.66
6422845-42284528.52728.55
720min1608287-60828741.03742.547.4041.1042.617.40
2593575-59357540.04540.11
3616329-61632941.58041.65
4721367-72136748.66648.74
5607367-60736740.97541.04
6636656-63665642.95143.02
960min1776249-77624952.36854.838.9852.5054.968.98
2752087-75208750.73850.86
3778999-77899952.55452.68
4949500-94950064.05764.21
5780413-78041352.64952.78
6839378-83937856.62756.76
1200min1984004-98400466.38473.1214.1066.5973.3414.08
2967155-96715565.24865.45
31002693-100269367.64567.85
41377579-137757992.93693.18
51073578-107357872.42772.64
61098300-109830074.09574.31
1440min11287473-128747386.85791.624.8787.1691.954.89
21318308-131830888.93889.24
31388980-138898093.70594.01
41471772-147177299.29199.68
51320893-132089389.11289.43
61361323-136132391.84092.17
极限11365822-136582292.14395.993.6192.5896.453.63
21405663-140566394.83195.26
31426050-142605096.20696.66
41491721-1491721100.637101.17
51374469-137446992.72693.18
61473324-147332499.39699.86
氟伐他汀钠片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
111.031454285145678514541891454197145372814546370.09
210.941432487143308014327840.03
单位质量响应值RSD%判断
131880.05130967.460.50数据可信
供试品溶液-23121102批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1242876-24287616.38616.404.7116.3916.404.70
2245683-24568316.57516.58
3243599-24359916.43516.43
4257484-25748417.37117.37
5222446-22244615.00715.01
6246861-24686116.65516.65
480min1461847-46184731.15931.805.4431.1831.835.44
2464432-46443231.33331.36
3468502-46850231.60831.63
4517893-51789334.94034.97
5440492-44049229.71829.74
6475182-47518232.05832.08
720min1665689-66568944.91146.027.5644.9846.097.56
2652411-65241144.01544.09
3663246-66324644.74644.82
4786666-78666653.07353.15
5656408-65640844.28544.35
6668300-66830045.08745.16
960min1864262-86426258.30860.619.3358.4560.759.32
2832245-83224556.14856.29
3857744-85774457.86858.01
41060638-106063871.55671.71
5913476-91347661.62861.76
6861643-86164358.13158.27
1200min11165074-116507478.60281.939.8478.8382.169.83
21115210-111521075.23875.46
31152039-115203977.72377.95
41406181-140618194.86995.13
51319366-131936689.01289.24
61128437-112843776.13176.36
1440min11437966-143796697.01394.004.4297.3694.364.42
21299222-129922287.65387.99
31389273-138927393.72894.07
41436318-143631896.90297.31
51454173-145417398.10798.47
61342938-134293890.60290.94
极限11465993-146599398.90496.602.4699.3997.102.46
21379073-137907393.04093.51
31413155-141315595.33995.82
41439369-143936997.10897.66
51473120-147312099.38599.89
61420413-142041395.82996.31
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