厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.952059953205824820588492055859205348020572780.13
215.092059109205923620591720.01
单位质量响应值RSD%判断
137610.57136459.380.60数据可信
供试品溶液-DA390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%
5min1397405-39740517.40015.5711.1117.4015.5611.10
2288645-28864512.63812.64
3378443-37844316.57016.57
4341530-34153014.95414.95
5382343-38234316.74116.74
6344645-34464515.09015.09
10min11092513-109251347.83645.994.9447.9346.084.95
2973109-97310942.60842.68
31116387-111638748.88148.97
41019497-101949744.63944.72
51064207-106420746.59746.69
61036603-103660345.38845.47
15min11435014-143501462.83260.762.9563.1961.102.96
21351894-135189459.19359.50
31411731-141173161.81362.18
41331011-133101158.27958.61
51378048-137804860.33860.69
61418729-141872962.11962.46
20min11566952-156695268.60968.841.3969.3269.521.39
21578481-157848169.11469.75
31603758-160375870.22170.93
41543499-154349967.58268.24
51585853-158585369.43770.12
61555179-155517968.09468.77
30min11823744-182374479.85379.341.0480.9580.401.02
21831036-183103680.17281.19
31802301-180230178.91480.01
41793084-179308478.51179.54
51791331-179133178.43479.51
61831081-183108180.17481.23
45min11866887-186688781.74284.451.8183.2885.951.78
21908682-190868283.57285.04
31940675-194067584.97386.51
41943816-194381685.11086.58
51954468-195446885.57787.09
61957551-195755185.71287.22
60min11990450-199045087.15288.620.8789.1490.600.85
22020356-202035688.46290.39
32028909-202890988.83690.84
42030373-203037388.90090.84
52036586-203658689.17291.16
62037714-203771489.22291.20
90min12100285-210028591.96193.200.9494.4495.660.90
22154174-215417494.32196.74
32116848-211684892.68795.19
42129058-212905893.22195.65
52123523-212352392.97995.46
62147500-214750094.02996.51
120min12035301-203530189.11690.962.1392.1093.952.05
22111224-211122492.44095.39
32102277-210227792.04995.06
42090978-209097891.55494.51
52115308-211530892.61995.62
62009765-200976587.99891.00
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限12126869-212686993.12593.100.8196.6196.580.75
22149391-214939194.11297.57
32096165-209616591.78195.31
42128907-212890793.21596.67
52128397-212839793.19296.70
62127312-212731293.14596.63
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.952051483205746620517132051887205208920529280.13
215.092047874204859520482340.03
单位质量响应值RSD%判断
137319.60135734.530.83数据可信
供试品溶液-DA390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%
5min1359978-35997815.82116.795.2315.8216.795.24
2378034-37803416.61416.61
3393835-39383517.30917.31
4357879-35787915.72815.73
5404340-40434017.77017.77
6398584-39858417.51717.52
10min11102211-110221148.44148.131.3448.5348.221.34
21098870-109887048.29448.39
31068447-106844746.95747.05
41089768-108976847.89447.98
51110692-111069248.81448.91
61100462-110046248.36448.46
15min11382596-138259660.76362.032.1161.1262.402.11
21402366-140236661.63261.99
31377848-137784860.55560.91
41419768-141976862.39762.75
51454782-145478263.93664.31
61431679-143167962.92163.29
20min11593810-159381070.04670.581.3570.7471.291.35
21589195-158919569.84370.55
31578964-157896469.39470.09
41628026-162802671.55072.25
51615692-161569271.00871.73
61630600-163060071.66372.38
30min11841063-184106380.91379.872.1282.0080.962.10
21791285-179128578.72579.82
31750437-175043776.93078.01
41848088-184808881.22182.32
51837020-183702080.73581.85
61835628-183562880.67481.79
45min11966069-196606986.40685.751.2887.9487.291.27
21971537-197153786.64788.18
31903262-190326283.64685.15
41961288-196128886.19687.75
51947992-194799285.61287.18
61956697-195669785.99587.56
60min12023812-202381288.94487.692.0290.9689.702.00
22008688-200868888.27990.29
31915171-191517184.16986.14
42019837-201983788.76990.80
52001916-200191687.98290.03
62001751-200175187.97590.01
90min12070427-207042790.99390.570.9493.5093.070.94
22056653-205665390.38792.89
32030350-203035089.23191.67
42088449-208844991.78594.31
52064415-206441590.72993.26
62054106-205410690.27692.80
120min12133296-213329693.75693.011.4296.7796.021.39
22083933-208393391.58694.59
32096656-209665692.14695.08
42109925-210992592.72995.76
52167391-216739195.25498.29
62107193-210719392.60995.64
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限12153239-215323994.63293.731.7398.1797.251.71
22139393-213939394.02497.53
32063028-206302890.66894.11
42127542-212754293.50397.05
52168081-216808195.28598.85
62144986-214498694.27097.81
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