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%
111.221512278151272215128121513329151246515127210.03
211.151509507150906315092850.03
单位质量响应值RSD%判断
134823.62135361.880.29数据可信
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%
60min1121095-1210958.2808.124.998.288.114.99
2129315-1293158.8428.84
3113600-1136007.7677.77
4117196-1171968.0138.01
5113547-1135477.7647.76
6117370-1173708.0258.02
120min1235037-23503716.07016.044.0416.0816.054.04
2252374-25237417.25617.27
3226765-22676515.50515.52
4226333-22633315.47515.49
5233102-23310215.93815.95
6234003-23400316.00016.01
240min1467971-46797131.99731.442.9632.0331.472.96
2480276-48027632.83832.88
3445060-44506030.43030.47
4449438-44943830.73030.76
5465226-46522631.80931.84
6450823-45082330.82430.86
360min1699077-69907747.79846.833.0647.8846.913.06
2714192-71419248.83248.92
3661604-66160445.23645.32
4660777-66077745.17945.26
5687626-68762647.01547.10
6686005-68600546.90446.99
480min1909444-90944462.18260.961.7562.3461.111.75
2900778-90077861.58961.75
3905656-90565661.92362.07
4873678-87367859.73659.89
5881966-88196660.30360.46
6877513-87751359.99860.15
600min11085841-108584174.24273.281.7074.4973.521.70
21077074-107707473.64373.90
31095960-109596074.93475.18
41057466-105746672.30272.54
51046797-104679771.57371.82
61067358-106735872.97973.22
720min11241265-124126584.86983.652.3585.2384.012.34
21227729-122772983.94484.31
31256969-125696985.94386.30
41202956-120295682.25082.60
51177555-117755580.51380.86
61234194-123419484.38684.74
840min11384856-138485694.68795.014.7295.1895.494.70
21456234-145623499.567100.06
31473625-1473625100.756101.24
41348288-134828892.18792.66
51300230-130023088.90189.37
61374073-137407393.95094.43
960min11492376-1492376102.039101.851.10102.67102.471.10
21507325-1507325103.061103.70
31504136-1504136102.843103.48
41462336-146233699.985100.59
51482975-1482975101.396102.00
61488216-1488216101.754102.37
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11488795-1488795101.794101.770.56102.58102.540.56
21496984-1496984102.354103.15
31498439-1498439102.453103.24
41480207-1480207101.207101.97
51478794-1478794101.110101.87
61487195-1487195101.684102.46
1200min11490320-1490320101.898101.840.61102.83102.760.61
21502129-1502129102.705103.65
31497320-1497320102.377103.32
41478622-1478622101.098102.01
51484810-1484810101.521102.43
61483200-1483200101.411102.34
1320min11487515-1487515101.706101.570.73102.79102.650.74
21497802-1497802102.410103.51
31498750-1498750102.474103.57
41475141-1475141100.860101.92
51475983-1475983100.918101.98
61477995-1477995101.055102.13
1440min11484987-1484987101.533101.370.68102.77102.610.69
21494947-1494947102.214103.47
31492714-1492714102.062103.31
41469432-1469432100.470101.68
51474792-1474792100.836102.05
61479137-1479137101.133102.36
极限11477027-1477027100.989101.130.69102.38102.520.70
21493716-1493716102.130103.54
31488714-1488714101.788103.19
41467620-1467620100.346101.71
51470890-1470890100.569101.93
61476833-1476833100.976102.36
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%
111.221511282150963415072521506696150627715082280.15
211.151494680149310014938900.08
单位质量响应值RSD%判断
134423.17133981.170.24数据可信
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%
60min1118656-1186568.1677.2014.868.177.2014.89
274293-742935.1135.11
3111671-1116717.6867.69
4109352-1093527.5267.53
5104787-1047877.2127.21
6108993-1089937.5027.50
120min1227503-22750315.65814.6811.2815.6714.6911.28
2166240-16624011.44211.45
3232949-23294916.03316.04
4219595-21959515.11415.13
5220358-22035815.16715.18
6213175-21317514.67214.68
240min1461825-46182531.78629.039.5731.8229.069.56
2351970-35197024.22524.25
3438859-43885930.20530.24
4415336-41533628.58628.62
5455136-45513631.32631.36
6407432-40743228.04228.08
360min1708277-70827748.74844.368.4048.8344.448.40
2554206-55420638.14438.21
3631670-63167043.47643.56
4652240-65224044.89244.97
5689498-68949847.45647.54
6631337-63133743.45343.53
480min1929314-92931463.96259.176.7164.1259.316.71
2775033-77503353.34353.46
3808463-80846355.64455.79
4875171-87517160.23560.38
5899885-89988561.93662.09
6870188-87018859.89260.03
600min11104879-110487976.04571.975.6376.3072.205.64
2979117-97911767.39067.59
3966000-96600066.48766.72
41076598-107659874.09974.33
51089747-108974775.00475.25
61057843-105784372.80873.04
720min11260128-126012886.73183.434.8487.1083.774.85
21152286-115228679.30879.61
31124706-112470677.41077.74
41253572-125357286.27986.63
51252554-125255486.20986.57
61229728-122972884.63884.98
840min11408377-140837796.93494.585.1097.4395.045.10
21297855-129785589.32789.75
31293416-129341689.02289.47
41477963-1477963101.724102.20
51388616-138861695.57496.06
61378449-137844994.87495.34
960min11506076-1506076103.658102.931.78104.30103.541.79
21442366-144236699.27499.83
31500881-1500881103.301103.88
41503344-1503344103.470104.10
51515030-1515030104.275104.90
61505365-1505365103.610104.22
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11503628-1503628103.490103.520.80104.29104.280.81
21483804-1483804102.126102.83
31513959-1513959104.201104.93
41501853-1501853103.368104.15
51518110-1518110104.487105.27
61502980-1502980103.445104.21
1200min11505239-1505239103.601103.690.98104.55104.610.98
21491254-1491254102.638103.49
31531285-1531285105.394106.28
41499625-1499625103.214104.15
51515627-1515627104.316105.26
61496546-1496546103.003103.92
1320min11500701-1500701103.289103.410.66104.40104.490.68
21486778-1486778102.330103.34
31512466-1512466104.098105.15
41497267-1497267103.052104.14
51512798-1512798104.121105.22
61505155-1505155103.595104.67
1440min11498340-1498340103.126103.120.75104.39104.350.76
21479538-1479538101.832102.99
31506532-1506532103.690104.89
41498567-1498567103.142104.39
51511945-1511945104.062105.32
61494748-1494748102.879104.11
极限11492260-1492260102.708102.850.73104.13104.230.74
21475347-1475347101.544102.86
31504684-1504684103.563104.92
41495981-1495981102.964104.37
51504604-1504604103.557104.97
61492849-1492849102.748104.13
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