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%
111.361548692154737815475251546244154625115472180.07
211.301552274155233815523060.01
单位质量响应值RSD%判断
136198.77137372.210.61数据可信
长期24月-供试品溶液-X0734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%
240min1429577-42957729.00926.958.7929.0126.958.79
2402729-40272927.19627.20
3423853-42385328.62228.62
4333197-33319722.50022.50
5413164-41316427.90027.90
6391796-39179626.45726.46
480min1847520-84752057.23153.856.7157.2753.896.72
2778715-77871552.58552.63
3833996-83399656.31856.36
4715359-71535948.30748.34
5844897-84489757.05457.10
6763865-76386551.58251.62
720min11198803-119880380.95378.644.9781.0878.764.97
21167479-116747978.83878.96
31213163-121316381.92382.05
41062407-106240771.74271.85
51208939-120893981.63781.76
61136772-113677276.76476.88
960min11464589-146458998.90199.941.1399.15100.181.14
21486508-1486508100.381100.62
31483725-1483725100.193100.44
41476661-147666199.71699.93
51507034-1507034101.767102.02
61460997-146099798.65898.89
1200min11458673-145867398.50199.421.1398.9099.811.13
21478458-147845899.837100.23
31465324-146532498.95099.35
41473401-147340199.49699.86
51501220-1501220101.374101.78
61456474-145647498.35398.73
1440min11450982-145098297.98299.161.1198.5399.701.11
21474482-147448299.569100.11
31457745-145774598.43998.99
41464589-146458998.90199.41
51497384-1497384101.115101.67
61465278-146527898.94799.48
极限11448010-144801097.78198.680.9998.4899.370.99
21464825-146482598.91799.60
31449829-144982997.90498.60
41461776-146177698.71199.37
51487686-1487686100.461101.17
61456223-145622398.33699.01
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%
111.361553542155371415542521554012155296215536960.04
211.301550862155134715511040.03
单位质量响应值RSD%判断
136769.01137265.840.26数据可信
长期24月-供试品溶液-X0734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%
240min1379602-37960225.59026.766.9125.5926.766.92
2407334-40733427.45927.46
3444557-44455729.96929.97
4366769-36676924.72524.72
5399482-39948226.93026.93
6384044-38404425.88925.89
480min1757880-75788051.09154.035.5251.1354.075.52
2794446-79444653.55653.60
3873493-87349358.88558.93
4754474-75447450.86150.90
5807879-80787954.46154.50
6820813-82081355.33355.37
720min11125909-112590975.90179.623.1876.0279.753.18
21179532-117953279.51579.64
31231120-123112082.99383.13
41152641-115264177.70377.82
51193643-119364380.46780.59
61203855-120385581.15581.28
960min11463341-146334198.64899.791.3198.88100.041.31
21461189-146118998.50398.74
31473774-147377499.35199.61
41495855-1495855100.840101.07
51477226-147722699.58499.83
61510655-1510655101.837102.08
1200min11457418-145741898.24999.711.4998.63100.101.48
21460966-146096698.48898.88
31471083-147108399.17099.58
41490436-1490436100.474100.86
51477736-147773699.618100.01
61516754-1516754102.249102.64
1440min11450379-145037997.77499.181.4398.3099.721.42
21450770-145077097.80098.34
31460578-146057898.46299.02
41483256-148325699.990100.52
51479438-147943899.733100.27
61503089-1503089101.327101.88
极限11450686-145068697.79598.901.2598.4799.581.24
21450252-145025297.76598.45
31461593-146159398.53099.23
41479783-147978399.756100.44
51462828-146282898.61399.30
61497017-1497017100.918101.62
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