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%
111.521512278151272215128121513329151246515127210.03
211.601509507150906315092850.03
单位质量响应值RSD%判断
131312.59130110.780.66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%
60min1121095-1210958.5578.394.998.568.395.01
2129315-1293159.1389.14
3113600-1136008.0288.03
4117196-1171968.2828.28
5113547-1135478.0248.02
6117370-1173708.2948.29
120min1235037-23503716.60916.584.0416.6216.594.04
2252374-25237417.83417.85
3226765-22676516.02516.04
4226333-22633315.99416.01
5233102-23310216.47216.48
6234003-23400316.53616.55
240min1467971-46797133.07032.492.9633.1132.532.95
2480276-48027633.93933.98
3445060-44506031.45131.49
4449438-44943831.76031.80
5465226-46522632.87632.91
6450823-45082331.85831.90
360min1699077-69907749.40148.403.0649.4948.483.06
2714192-71419250.46950.56
3661604-66160446.75346.84
4660777-66077746.69546.78
5687626-68762648.59248.68
6686005-68600548.47748.56
480min1909444-90944464.26763.001.7564.4363.161.75
2900778-90077863.65463.82
3905656-90565663.99964.15
4873678-87367861.73961.89
5881966-88196662.32562.48
6877513-87751362.01062.17
600min11085841-108584176.73275.741.7076.9975.991.70
21077074-107707476.11376.38
31095960-109596077.44777.70
41057466-105746674.72774.97
51046797-104679773.97374.23
61067358-106735875.42675.68
720min11241265-124126587.71586.462.3588.0986.822.34
21227729-122772986.75987.14
31256969-125696988.82589.19
41202956-120295685.00885.37
51177555-117755583.21383.58
61234194-123419487.21687.58
840min11384856-138485697.86298.194.7298.3798.694.70
21456234-1456234102.906103.41
31473625-1473625104.135104.63
41348288-134828895.27895.76
51300230-130023091.88292.37
61374073-137407397.10097.60
960min11492376-1492376105.460105.261.10106.11105.911.10
21507325-1507325106.517107.18
31504136-1504136106.291106.95
41462336-1462336103.338103.97
51482975-1482975104.796105.42
61488216-1488216105.166105.81
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11488795-1488795105.207105.180.56106.02105.980.57
21496984-1496984105.786106.61
31498439-1498439105.889106.70
41480207-1480207104.600105.38
51478794-1478794104.501105.28
61487195-1487195105.094105.89
1200min11490320-1490320105.315105.250.61106.28106.210.61
21502129-1502129106.150107.13
31497320-1497320105.810106.78
41478622-1478622104.488105.43
51484810-1484810104.926105.87
61483200-1483200104.812105.77
1320min11487515-1487515105.117104.980.73106.24106.090.74
21497802-1497802105.844106.98
31498750-1498750105.911107.04
41475141-1475141104.242105.34
51475983-1475983104.302105.40
61477995-1477995104.444105.56
1440min11484987-1484987104.938104.770.68106.22106.050.70
21494947-1494947105.642106.94
31492714-1492714105.484106.78
41469432-1469432103.839105.09
51474792-1474792104.218105.47
61479137-1479137104.525105.79
极限11477027-1477027104.376104.520.69105.82105.960.70
21493716-1493716105.555107.01
31488714-1488714105.202106.65
41467620-1467620103.711105.12
51470890-1470890103.942105.35
61476833-1476833104.362105.79
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%
111.521511282150963415072521506696150627715082280.15
211.601494680149310014938900.08
单位质量响应值RSD%判断
130922.57128783.621.17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%
60min1118656-1186568.4417.4414.868.447.4414.88
274293-742935.2855.28
3111671-1116717.9447.94
4109352-1093527.7797.78
5104787-1047877.4547.45
6108993-1089937.7537.75
120min1227503-22750316.18415.1711.2816.2015.1811.29
2166240-16624011.82611.83
3232949-23294916.57116.58
4219595-21959515.62115.63
5220358-22035815.67615.69
6213175-21317515.16515.18
240min1461825-46182532.85330.009.5732.8930.049.57
2351970-35197025.03825.06
3438859-43885931.21931.26
4415336-41533629.54629.58
5455136-45513632.37732.41
6407432-40743228.98329.02
360min1708277-70827750.38445.858.4050.4745.938.40
2554206-55420639.42439.49
3631670-63167044.93545.02
4652240-65224046.39846.48
5689498-68949849.04949.13
6631337-63133744.91144.99
480min1929314-92931466.10861.156.7166.2761.306.71
2775033-77503355.13355.26
3808463-80846357.51157.66
4875171-87517162.25762.41
5899885-89988564.01564.17
6870188-87018861.90262.05
600min11104879-110487978.59774.395.6378.8674.635.63
2979117-97911769.65169.86
3966000-96600068.71868.96
41076598-107659876.58676.83
51089747-108974777.52177.77
61057843-105784375.25175.49
720min11260128-126012889.64186.234.8490.0286.584.84
21152286-115228681.97082.28
31124706-112470680.00880.35
41253572-125357289.17589.53
51252554-125255489.10389.47
61229728-122972887.47987.83
840min11408377-1408377100.18797.755.10100.7098.235.10
21297855-129785592.32592.76
31293416-129341692.00992.47
41477963-1477963105.137105.63
51388616-138861698.78299.28
61378449-137844998.05898.54
960min11506076-1506076107.137106.391.78107.80107.021.79
21442366-1442366102.605103.18
31500881-1500881106.768107.37
41503344-1503344106.943107.59
51515030-1515030107.774108.43
61505365-1505365107.087107.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11503628-1503628106.963106.990.80107.79107.780.81
21483804-1483804105.553106.28
31513959-1513959107.698108.46
41501853-1501853106.837107.65
51518110-1518110107.993108.81
61502980-1502980106.917107.71
1200min11505239-1505239107.078107.170.98108.06108.120.97
21491254-1491254106.083106.97
31531285-1531285108.931109.85
41499625-1499625106.678107.65
51515627-1515627107.817108.79
61496546-1496546106.459107.41
1320min11500701-1500701106.755106.880.66107.90107.990.67
21486778-1486778105.764106.81
31512466-1512466107.592108.68
41497267-1497267106.511107.64
51512798-1512798107.615108.75
61505155-1505155107.072108.18
1440min11498340-1498340106.587106.580.75107.89107.850.76
21479538-1479538105.249106.45
31506532-1506532107.170108.41
41498567-1498567106.603107.89
51511945-1511945107.555108.85
61494748-1494748106.331107.60
极限11492260-1492260106.154106.300.73107.62107.730.74
21475347-1475347104.951106.31
31504684-1504684107.038108.44
41495981-1495981106.419107.87
51504604-1504604107.033108.49
61492849-1492849106.196107.63
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