替米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100629-202204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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.037486797488957499107494827502587494450.09
211.097414977413897414430.02
单位质量响应值RSD%判断
67946.0666856.901.15数据可信
供试品溶液-2024070521批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1294880-29488039.37740.161.2739.3840.161.26
2303602-30360240.54240.54
3304514-30451440.66440.66
4299797-29979740.03440.03
5301021-30102140.19740.20
10min1306369-30636940.91264.6520.6341.1364.8820.57
2538362-53836271.89172.12
3519439-51943969.36469.59
4538529-53852971.91472.14
5518016-51801669.17469.40
15min1509946-50994668.09781.0213.4168.5481.6113.38
2529487-52948770.70671.33
3677534-67753490.47691.09
4638493-63849385.26285.88
5678324-67832490.58191.19
20min1672033-67203389.74191.535.3090.5792.575.29
2657481-65748187.79888.82
3649744-64974486.76587.88
4729709-72970997.44398.54
5718262-71826295.91597.03
30min1741318-74131898.99397.321.44100.3298.871.30
2738124-73812498.567100.07
3719861-71986196.12897.72
4718453-71845395.94097.58
5726350-72635096.99598.64
45min1736998-73699898.41698.391.65100.29100.471.60
2733873-73387397.999100.05
3755483-755483100.885103.01
4735898-73589898.270100.44
5721731-72173196.37898.56
60min1727032-72703297.08698.561.2999.51101.191.32
2744627-74462799.435102.03
3744709-74470999.446102.14
4745568-74556899.561102.28
5728401-72840197.26899.99
极限1741762-74176299.05398.050.87102.01101.220.79
2728827-72882797.325100.47
3729397-72939797.401100.64
4730712-73071297.577100.85
5740574-74057498.894102.15
替米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100629-202204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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.037515767514777512947552177516107522350.23
211.097434987443907439440.09
单位质量响应值RSD%判断
68199.0067082.421.17数据可信
供试品溶液-F49232批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188006-18800625.01729.539.0525.0229.539.05
2234935-23493531.26231.26
3235656-23565631.35831.36
4231786-23178630.84330.84
5219285-21928529.17929.18
10min1358333-35833347.68253.456.3447.8253.616.35
2423266-42326656.32256.50
3412433-41243354.88055.05
4413127-41312754.97355.14
5401198-40119853.38553.55
15min1512240-51224068.16170.923.3768.5771.383.38
2555977-55597773.98174.47
3540227-54022771.88572.36
4538790-53879071.69472.17
5517468-51746868.85769.32
20min1642331-64233185.47284.503.5886.2585.363.54
2666945-66694588.74789.64
3607380-60738080.82181.70
4638035-63803584.90085.78
5620495-62049582.56683.41
30min1752356-752356100.11299.092.96101.37100.422.93
2769103-769103102.341103.73
3753740-753740100.296101.62
4710822-71082294.58695.93
5737437-73743798.12799.43
45min1754270-754270100.36799.772.05102.18101.642.02
2751847-751847100.045102.00
3768846-768846102.307104.19
4726370-72637096.65498.53
5747476-74747699.463101.31
60min1748548-74854899.60699.253.32101.98101.683.26
2766648-766648102.014104.53
3745098-74509899.146101.60
4704992-70499293.81096.22
5763982-763982101.659104.06
极限1755790-755790100.56998.362.77103.49101.342.68
2732565-73256597.479100.56
3740869-74086998.584101.59
4707987-70798794.20897.14
5758550-758550100.936103.90
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