塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.042991982299345729915752989728299120029915880.05
210.143007330299845230028910.21
单位质量响应值RSD%判断
297966.93296143.100.44数据可信
供试品溶液-25010701-2批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1469863-46986315.75416.586.3715.7516.586.37
2513009-51300917.20117.20
3485664-48566416.28416.28
4464833-46483315.58615.59
5548806-54880618.40118.40
6484368-48436816.24116.24
10min11062120-106212035.61236.824.1935.6436.864.20
21111692-111169237.27437.31
31088944-108894436.51236.54
41063689-106368935.66535.70
51184404-118440439.71239.75
61078514-107851436.16236.19
15min11544006-154400651.77053.112.9451.8753.212.95
21592392-159239253.39253.50
31574082-157408252.77852.88
41555682-155568252.16152.26
51672774-167277456.08756.20
61564222-156422252.44852.55
20min11928043-192804364.64665.661.7064.8565.871.71
21953860-195386065.51265.73
31950691-195069165.40665.62
41947418-194741865.29665.50
52023550-202355067.84968.08
61945918-194591865.24665.46
30min12407151-240715180.71080.900.8481.0581.240.85
22422400-242240081.22281.57
32403771-240377180.59780.94
42395011-239501180.30380.64
52449243-244924382.12282.49
62399016-239901680.43880.78
45min12679479-267947989.84189.860.4490.3490.360.44
22693156-269315690.30090.81
32682364-268236489.93890.44
42684029-268402989.99490.49
52682235-268223589.93490.46
62658063-265806389.12389.62
60min12769884-276988492.87393.010.4493.5593.690.44
22782904-278290493.30994.00
32783269-278326993.32294.00
42785015-278501593.38094.06
52768010-276801092.81093.52
62754327-275432792.35193.03
极限12808991-280899194.18494.380.4495.0595.250.43
22826492-282649294.77195.65
32824554-282455494.70695.58
42825077-282507794.72395.59
52805112-280511294.05494.95
62798225-279822593.82394.69
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.042991717299333429931982988415299052229914370.07
210.142991583299116429913740.01
单位质量响应值RSD%判断
297951.89295007.300.71数据可信
供试品溶液-25010702批-pH12.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1442598-44259814.86914.712.5614.8714.702.56
2439774-43977414.77414.77
3442136-44213614.85414.85
4445308-44530814.96014.96
5415208-41520813.94913.95
6441569-44156914.83514.83
10min11006675-100667533.81933.482.0633.8533.512.06
2994504-99450433.41033.44
31009777-100977733.92433.95
41014371-101437134.07834.11
5957945-95794532.18232.21
6995992-99599233.46033.49
15min11459146-145914649.02049.202.2949.1249.302.29
21464002-146400249.18349.28
31487899-148789949.98650.08
41510259-151025950.73750.84
51411200-141120047.40947.50
61454360-145436048.85948.96
20min11819999-181999961.14361.592.3561.3461.792.35
21846717-184671762.04162.24
31867430-186743062.73662.93
41883403-188340363.27363.47
51762364-176236459.20759.39
61820270-182027061.15261.35
30min12296820-229682077.16277.241.9277.4877.561.92
22305787-230578777.46377.78
32330309-233030978.28778.61
42355602-235560279.13779.46
52227532-222753274.83475.14
62279275-227927576.57276.89
45min12580730-258073086.70086.790.8087.1787.260.80
22588763-258876386.97087.44
32600648-260064887.36987.85
42605564-260556487.53488.02
52548501-254850185.61786.07
62576480-257648086.55787.03
60min12689045-268904590.33990.670.4290.9891.320.43
22703505-270350590.82491.47
32709470-270947091.02591.68
42708955-270895591.00791.67
52681513-268151390.08690.71
62700791-270079190.73391.38
极限12759855-275985592.71792.780.1993.5493.610.20
22762511-276251192.80793.64
32768730-276873093.01693.85
42764916-276491692.88793.73
52753458-275345892.50393.31
62761272-276127292.76593.59
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