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%
110.741416431141469714185341413046141616514157750.15
211.231489625148857514891000.05
单位质量响应值RSD%判断
131822.63132600.180.42数据可信
供试品溶液-X0735批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1198933-19893313.34114.1511.5013.3414.1511.51
2237467-23746715.92515.93
3186131-18613112.48312.48
4183358-18335812.29712.30
5228683-22868315.33615.34
6230960-23096015.48915.49
480min1371248-37124824.89725.3610.1724.9225.3810.17
2423407-42340728.39528.42
3344822-34482223.12523.14
4324174-32417421.74021.76
5397734-39773426.67326.70
6407827-40782727.35027.37
720min1517054-51705434.67533.877.3834.7333.937.38
2539968-53996836.21236.28
3472956-47295631.71831.77
4445913-44591329.90429.96
5533296-53329635.76535.83
6520953-52095334.93735.00
1440min1789639-78963952.95655.0211.7053.0755.1311.66
2797644-79764453.49353.61
3758190-75819050.84750.95
41014297-101429768.02268.12
5785897-78589752.70552.82
6776900-77690052.10252.22
极限1951944-95194463.84162.008.5764.0362.198.55
2890706-89070659.73459.93
3868886-86888658.27058.45
41074458-107445872.05772.25
5881751-88175159.13359.33
6879170-87917058.96059.15
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%
110.741420089142113414236141423104142385314223590.12
211.231486113148561214858620.03
单位质量响应值RSD%判断
132435.66132311.840.07数据可信
供试品溶液-X0735批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1216932-21693214.53013.3612.0114.5313.3612.03
2218654-21865414.64614.65
3177808-17780811.91011.91
4184846-18484612.38112.38
5226922-22692215.19915.20
6171899-17189911.51411.51
480min1362405-36240524.27423.9212.3724.3023.9412.37
2403621-40362127.03527.06
3304825-30482520.41720.44
4355344-35534423.80123.82
5407498-40749827.29427.32
6309239-30923920.71320.73
720min1507707-50770734.00632.7710.0734.0632.8310.07
2541773-54177336.28836.35
3447008-44700829.94129.99
4462099-46209930.95231.01
5545621-54562136.54636.61
6431536-43153628.90528.95
1440min1747478-74747850.06651.286.9350.1851.386.94
2804333-80433353.87553.99
3723776-72377648.47948.57
4767564-76756451.41251.51
5846776-84677656.71856.84
6703237-70323747.10347.19
极限11115202-111520274.69762.2011.2574.8862.3811.23
2888778-88877859.53159.73
3828692-82869255.50655.67
4939420-93942062.92363.10
5956241-95624164.05064.25
6843459-84345956.49556.66
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%
110.741419163141951214204431421258141975314200260.06
211.231475349147692814761380.08
单位质量响应值RSD%判断
132218.44131445.950.42数据可信
供试品溶液-2024022621批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1211002-21100214.19115.0213.8014.1915.0213.81
2231140-23114015.54615.55
3235408-23540815.83315.83
4236635-23663515.91515.92
5168317-16831711.32011.32
6257781-25778117.33717.34
480min1369351-36935124.84126.4213.6424.8626.4413.64
2393640-39364026.47526.50
3408109-40810927.44827.47
4422715-42271528.43028.45
5302766-30276620.36320.38
6460367-46036730.96330.99
720min1506709-50670934.07936.7715.4334.1436.8315.43
2537279-53727936.13536.20
3561849-56184937.78837.85
4601395-60139540.44840.51
5413156-41315627.78727.83
6659940-65994044.38544.46
1440min11045879-104587970.34265.3818.8570.4565.5018.84
21070896-107089672.02472.14
3817998-81799855.01555.14
41099288-109928873.93474.06
5673260-67326045.28145.37
61125226-112522675.67875.82
极限11118809-111880975.24770.2815.0875.4670.5015.08
21122803-112280375.51675.74
3911210-91121061.28561.49
41160442-116044278.04778.29
5787967-78796752.99653.15
61168925-116892578.61878.87
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