坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.081730491736821734571730021732231732830.17
216.121735651735451735550.01
单位质量响应值RSD%判断
10776.3110766.440.07数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min160520-6052031.54134.679.4231.5434.679.42
259309-5930930.91030.91
364315-6431533.51933.52
474523-7452338.83938.84
567870-6787035.37235.37
672653-7265337.86537.86
10min1108130-10813056.35460.646.1056.7061.036.12
2108564-10856456.58156.92
3115025-11502559.94860.32
4125417-12541765.36465.80
5119005-11900562.02262.42
6122017-12201763.59264.01
15min1133073-13307369.35472.953.7870.3374.013.82
2134172-13417269.92770.90
3140123-14012373.02874.07
4142426-14242674.22975.39
5144417-14441775.26676.35
6145652-14565275.91077.04
20min1146505-14650576.35480.574.2478.1082.444.26
2149304-14930477.81379.56
3150676-15067678.52880.38
4161563-16156384.20286.18
5158465-15846582.58884.51
6161046-16104683.93385.90
30min1164459-16445985.71287.972.2688.3190.742.33
2165995-16599586.51289.13
3165847-16584786.43589.16
4171923-17192389.60292.52
5173522-17352290.43593.27
6170999-17099989.12092.02
45min1169859-16985988.52691.452.4092.0795.192.47
2172758-17275890.03793.61
3174267-17426790.82394.51
4179819-17981993.71797.63
5175262-17526291.34295.18
6180881-18088194.27098.16
60min1174513-17451390.95292.251.7295.4897.001.74
2176935-17693592.21496.79
3175476-17547691.45396.15
4182562-18256295.146100.10
5177950-17795092.74397.60
6174552-17455290.97295.91
极限1172136-17213689.71391.361.2195.2597.151.33
2173975-17397590.67196.27
3175081-17508191.24896.96
4178014-17801492.77698.79
5175619-17561991.52897.41
6177004-17700492.25098.20
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.081735991737661737321736401737011736880.04
216.121733451735971734710.11
单位质量响应值RSD%判断
10801.4910761.230.27数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min165295-6529533.99934.394.1434.0034.394.13
263448-6344833.03733.04
370487-7048736.70236.70
463331-6333132.97632.98
565981-6598134.35634.36
667726-6772635.26435.26
10min1121146-12114663.08064.131.7763.4664.511.78
2122585-12258563.82964.20
3127322-12732266.29666.70
4121974-12197463.51163.88
5122489-12248963.77964.16
6123423-12342364.26564.66
15min1146367-14636776.21276.731.0377.2977.831.02
2149341-14934177.76178.84
3148194-14819477.16378.31
4147230-14723076.66277.73
5145063-14506375.53376.62
6148028-14802877.07778.18
20min1159023-15902382.80283.340.8384.7385.280.84
2159469-15946983.03484.97
3162105-16210584.40786.41
4160901-16090183.78085.70
5158520-15852082.54084.47
6160307-16030783.47185.43
30min1170097-17009788.56888.990.9891.4191.870.99
2171320-17132089.20592.07
3173698-17369890.44393.38
4170716-17071688.89091.75
5168600-16860087.78990.64
6171055-17105589.06791.96
45min1172914-17291490.03590.520.9993.8694.380.99
2172551-17255189.84693.70
3176407-17640791.85495.80
4173253-17325390.21194.05
5172388-17238889.76193.58
6175569-17556991.41795.30
60min1171491-17149189.29489.781.4294.1294.651.40
2169123-16912388.06192.91
3175265-17526591.25996.22
4173214-17321490.19195.04
5170587-17058788.82393.64
6174898-17489891.06895.96
极限1170556-17055688.80789.370.8794.6395.230.88
2171118-17111889.10094.93
3174474-17447490.84796.83
4171258-17125889.17395.02
5170529-17052988.79394.60
6171840-17184089.47695.38
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.081731661732181732861733861732231732560.05
216.121752241750421751330.08
单位质量响应值RSD%判断
10774.6310864.330.59数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154186-5418628.11532.1015.3028.1232.1015.30
273812-7381238.29838.30
362402-6240232.37832.38
454765-5476528.41628.42
553212-5321227.61027.61
672856-7285637.80237.80
10min1114880-11488059.60762.073.7259.9262.423.78
2125074-12507464.89665.32
3120036-12003662.28262.64
4115632-11563259.99760.31
5117445-11744560.93861.24
6124670-12467064.68765.11
15min1143027-14302774.21275.521.3975.1976.571.42
2146965-14696576.25577.40
3143215-14321574.30975.36
4145560-14556075.52676.51
5146839-14683976.19077.17
6147730-14773076.65277.79
20min1155209-15520980.53280.921.2482.3382.811.16
2156586-15658681.24783.24
3154553-15455380.19282.07
4158077-15807782.02183.84
5158017-15801781.98983.82
6153351-15335179.56881.56
30min1165547-16554785.89786.181.5288.5988.961.41
2163282-16328284.72187.62
3164616-16461685.41388.18
4169547-16954787.97290.70
5168805-16880587.58790.33
6164707-16470785.46188.34
45min1173073-17307389.80188.691.1293.4592.431.02
2170545-17054588.49092.33
3170038-17003888.22791.94
4172095-17209589.29493.00
5172047-17204789.26992.98
6167739-16773987.03490.86
60min1168724-16872487.54588.831.0892.1993.561.06
2172841-17284189.68194.50
3169594-16959487.99692.69
4172355-17235589.42994.13
5173120-17312089.82694.53
6170573-17057388.50493.30
极限1170371-17037188.40088.310.7194.0294.030.68
2170311-17031188.36894.19
3168076-16807687.20992.88
4171705-17170589.09294.79
5170790-17079088.61794.32
6169968-16996888.19093.96
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