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100800-202103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%
110.991486870148836714889101488371148620814877450.08
210.801471727147201014718680.02
单位质量响应值RSD%判断
135372.61136284.070.48数据可信
长期12月-供试品溶液-2024041521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%
240min1448051-44805129.24829.734.2529.2529.734.25
2439604-43960428.69628.70
3491840-49184032.10632.11
4457523-45752329.86629.87
5455490-45549029.73329.73
6440211-44021128.73628.74
480min1856234-85623455.89358.497.0855.9458.547.07
2853112-85311255.68955.73
31013919-101391966.18666.23
4922764-92276460.23660.28
5856987-85698755.94255.99
6873382-87338257.01257.06
720min11263852-126385282.50181.404.8282.6381.544.82
21187294-118729477.50477.63
31345630-134563087.84087.99
41275851-127585183.28583.42
51199883-119988378.32678.45
61209552-120955278.95779.09
960min11534847-1534847100.19199.191.27100.4499.441.27
21503340-150334098.13598.38
31543618-1543618100.764101.04
41493435-149343597.48897.75
51526873-152687399.67199.92
61514911-151491198.89099.14
1200min11523583-152358399.45698.801.1399.8699.201.13
21500250-150025097.93398.32
31532619-1532619100.046100.48
41486741-148674197.05197.46
51522350-152235099.37699.77
61515494-151549498.92899.32
1440min11518542-151854299.12798.311.1199.6898.861.11
21492617-149261797.43597.97
31525184-152518499.561100.14
41481094-148109496.68297.23
51513531-151353198.80099.34
61504953-150495398.24098.78
极限11555672-1555672101.55198.592.02102.2599.292.02
21478247-147824796.49797.18
31532153-1532153100.015100.75
41478407-147840796.50797.20
51513375-151337598.79099.48
61504017-150401798.17998.87
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100800-202103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%
110.991487425148642714874381486825149582214887870.27
210.801462823146326014630420.03
单位质量响应值RSD%判断
135467.42135466.850.01数据可信
长期12月-供试品溶液-2024041521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%
240min1454028-45402829.71730.111.8129.7230.111.81
2460793-46079330.15930.16
3467003-46700330.56630.57
4454540-45454029.75029.75
5451398-45139829.54429.54
6472480-47248030.92430.92
480min1945912-94591261.91159.333.6961.9659.383.69
2850891-85089155.69255.74
3915693-91569359.93359.98
4892695-89269558.42858.47
5901637-90163759.01359.06
6931996-93199661.00061.05
720min11300854-130085485.14282.933.2785.2883.063.27
21190201-119020177.90078.03
31303610-130361085.32385.46
41259858-125985882.45982.59
51269322-126932283.07883.21
61278462-127846283.67783.81
960min11514150-151415099.10399.301.4699.3799.561.46
21494997-149499797.84998.09
31544602-1544602101.096101.36
41498611-149861198.08698.34
51544059-1544059101.060101.32
61506663-150666398.61398.88
1200min11510451-151045198.86198.611.5799.2799.021.57
21494837-149483797.83998.23
31533441-1533441100.365100.78
41483155-148315597.07497.48
51535058-1535058100.471100.88
61482924-148292497.05997.47
1440min11509595-150959598.80598.122.5299.3798.682.51
21489243-148924397.47298.01
31528263-1528263100.026100.59
41478313-147831396.75797.31
51547794-1547794101.305101.86
61441927-144192794.37694.93
极限11498713-149871398.09297.502.2398.8098.202.22
21485204-148520497.20897.89
31521767-152176799.601100.32
41473521-147352196.44397.14
51523477-152347799.713100.42
61435172-143517293.93394.63
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100800-202103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%
110.991498917149722214980321497878149925614982610.06
210.801473670147362114736460.01
单位质量响应值RSD%判断
136329.48136448.700.07数据可信
长期12月-供试品溶液-2024041721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%
240min1472669-47266930.72830.432.7630.7330.432.75
2453001-45300129.44929.45
3459275-45927529.85729.86
4466096-46609630.30030.30
5490417-49041731.88131.88
6466972-46697230.35730.36
480min1823702-82370253.54858.985.1553.5959.025.15
2880147-88014757.21757.26
3938446-93844661.00761.05
4935538-93553860.81860.86
5924576-92457660.10560.15
6940784-94078461.15961.20
720min11202950-120295078.20282.723.3178.3382.863.31
21244267-124426780.88881.02
31310751-131075185.21085.35
41296550-129655084.28784.42
51273914-127391482.81582.95
61306707-130670784.94785.08
960min11512935-151293598.35498.290.8398.6098.550.83
21509939-150993998.15998.41
31514295-151429598.44298.71
41521124-152112498.88699.15
51488917-148891796.79297.05
61524345-152434599.09699.36
1200min11506384-150638497.92897.720.6298.3298.130.62
21504363-150436397.79798.20
31507724-150772498.01598.43
41509848-150984898.15398.56
51484585-148458596.51196.92
61506186-150618697.91598.33
1440min11523620-152362099.04897.231.2699.5997.781.25
21503087-150308797.71498.26
31496146-149614697.26297.82
41501176-150117697.58998.15
51472463-147246395.72396.27
61476998-147699896.01896.58
极限11533281-153328199.67697.211.46100.3697.911.44
21499396-149939697.47498.17
31495381-149538197.21397.92
41494921-149492197.18397.89
51469272-146927295.51596.21
61480218-148021896.22796.93
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100800-202103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%
110.991490580149063214898491490913148963614903220.04
210.801470417146942814699220.05
单位质量响应值RSD%判断
135607.10136103.890.26数据可信
长期12月-供试品溶液-2024041721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%
240min1472694-47269430.85030.542.4930.8530.542.49
2454251-45425129.64629.65
3469942-46994230.67030.67
4452972-45297229.56329.56
5477283-47728331.14931.15
6480174-48017431.33831.34
480min1912120-91212059.52958.154.1159.5858.194.11
2851767-85176755.59055.63
3935757-93575761.07161.12
4849188-84918855.42255.47
5918959-91895959.97560.02
6877788-87778857.28857.34
720min11283330-128333083.75580.163.9983.8980.293.99
21174413-117441376.64776.77
31287408-128740884.02284.16
41191698-119169877.77577.90
51237748-123774880.78180.92
61194823-119482377.97978.11
960min11515174-151517498.88798.520.6299.1598.780.62
21506824-150682498.34298.58
31524997-152499799.52899.79
41508555-150855598.45598.70
51499522-149952297.86598.12
61502665-150266598.07098.32
1200min11507129-150712998.36198.710.9398.7799.120.93
21516112-151611298.94899.34
31516252-151625298.95799.37
41505040-150504098.22598.62
51494661-149466197.54897.95
61535939-1535939100.242100.64
1440min11501536-150153697.99698.140.8198.5598.690.80
21515010-151501098.87699.41
31511067-151106798.61899.18
41498461-149846197.79698.33
51483055-148305596.79097.34
61513238-151323898.76099.31
极限11477465-147746596.42597.261.1297.1397.961.11
21507190-150719098.36599.05
31487688-148768897.09397.80
41495399-149539997.59698.28
51466009-146600995.67896.37
61507736-150773698.40199.10
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