厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.138500708501428507448500018481218498160.12
214.998579538586628583080.06
单位质量响应值RSD%判断
56167.6157258.711.37数据可信
供试品溶液-25111201批-厄贝沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1287105-28710530.30712.91100.4630.3112.91100.47
2251280-25128026.52626.53
3-0.0000.00
481941-819418.6508.65
5-0.0000.00
6113216-11321611.95111.95
10min1728214-72821476.87168.3110.1177.2168.4610.21
2701062-70106274.00574.30
3652949-65294968.92668.93
4611450-61145064.54664.64
5644769-64476968.06368.06
6544280-54428057.45557.59
15min1792287-79228783.63587.602.7484.8388.502.65
2850497-85049789.78090.90
3827555-82755587.35888.12
4850972-85097289.83090.64
5816734-81673486.21686.97
6840888-84088888.76689.54
20min1874991-87499192.36591.762.3294.4993.642.35
2885417-88541793.46695.58
3856053-85605390.36692.10
4839074-83907488.57490.39
5865742-86574291.38993.10
6894379-89437994.41296.17
30min1864777-86477791.28792.081.1794.4394.981.19
2881145-88114593.01596.17
3866608-86660891.48194.22
4867007-86700791.52394.32
5865301-86530191.34394.07
6888912-88891293.83596.64
45min1812894-81289485.81090.133.5789.9794.043.43
2881452-88145293.04897.23
3853419-85341990.08893.85
4866809-86680991.50295.31
5822259-82225986.79990.54
6885948-88594893.52297.37
60min1873546-87354692.21391.361.3997.3396.281.46
2870307-87030791.87197.09
3851702-85170289.90794.67
4874319-87431992.29597.12
5848720-84872089.59294.30
6874262-87426292.28997.18
极限1872914-87291492.14691.291.4698.2897.231.55
2876120-87612092.48598.73
3844739-84473989.17294.93
4862592-86259291.05796.91
5856774-85677490.44296.15
6875819-87581992.45398.37
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.981259651260021260041259761257151259320.10
210.121274581272771273680.11
单位质量响应值RSD%判断
12618.4412585.770.19数据可信
供试品溶液-25111201批-非奈利酮-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15831-58314.1702.7578.344.172.7578.33
25531-55313.9563.96
3-0.0000.00
46547-65474.6824.68
5-0.0000.00
65185-51853.7083.71
10min142628-4262830.48624.2315.9930.5324.2615.97
230259-3025921.64021.68
333223-3322323.76023.76
435326-3532625.26425.32
535186-3518625.16425.16
626621-2662119.03819.08
15min164382-6438246.04440.4014.5946.4340.7014.57
248997-4899735.04135.33
352066-5206637.23637.50
462835-6283544.93745.27
564209-6420945.92046.20
646424-4642433.20133.45
20min182669-8266959.12249.3414.3860.0250.0914.36
261790-6179044.19044.86
363040-6304045.08445.76
469143-6914349.44950.28
579092-7909256.56457.35
658246-5824641.65642.28
30min199838-9983871.40160.3912.7372.9561.6912.75
277649-7764955.53256.70
378362-7836256.04257.22
483133-8313359.45460.84
595126-9512668.03169.45
672543-7254351.88052.96
45min1108892-10889277.87670.497.6680.2272.467.81
294937-9493767.89669.68
394268-9426867.41769.22
499183-9918370.93272.97
5105460-10546075.42177.60
688647-8864763.39765.06
60min1124294-12429488.89179.628.0992.1082.378.22
2106079-10607975.86478.40
3106427-10642776.11378.66
4112746-11274680.63283.46
5118584-11858484.80787.82
699877-9987771.42973.79
极限1139828-139828100.00093.338.22104.2096.968.23
2116887-11688783.59486.97
3136933-13693397.930101.33
4129454-12945492.58196.31
5141324-141324101.070105.02
6118567-11856784.79587.95
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