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%
111.137571317582487577757571387580427576670.07
211.167532957564257548600.30
单位质量响应值RSD%判断
68074.3067639.780.46数据可信
供试品溶液-2024070421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min188040-8804011.67712.125.8711.6812.135.87
289761-8976111.90511.91
395587-9558712.67812.68
483251-8325111.04211.04
594377-9437712.51812.52
697475-9747512.92812.93
10min1175725-17572523.30723.736.1123.3723.796.10
2166541-16654122.08922.15
3195910-19591025.98426.05
4168676-16867622.37222.43
5184081-18408124.41524.48
6182406-18240624.19324.26
15min1233829-23382931.01333.056.8531.2133.256.83
2233817-23381731.01231.20
3279308-27930837.04537.26
4242798-24279832.20332.39
5250674-25067433.24833.45
6254810-25481033.79634.00
20min1308184-30818440.87541.226.1041.2441.606.07
2290036-29003638.46838.83
3334556-33455644.37344.79
4315509-31550941.84742.21
5327775-32777543.47443.86
6288821-28882138.30738.70
30min1433244-43324457.46356.127.3858.0656.747.35
2391717-39171751.95552.53
3457766-45776660.71561.38
4401276-40127653.22253.82
5459607-45960760.95961.59
6395345-39534552.43653.04
45min1522866-52286669.34975.7710.2970.2676.6910.22
2554627-55462773.56274.43
3643897-64389785.40286.41
4529382-52938270.21471.11
5647650-64765085.90086.87
6529159-52915970.18471.08
60min1601331-60133179.75687.155.5481.0588.505.52
2623307-62330782.67183.94
3681620-68162090.40591.88
4666174-66617488.35789.64
5692557-69255791.85693.30
6677658-67765889.88091.17
90min1731692-73169297.04794.632.5698.7996.462.48
2696107-69610792.32794.06
3689011-68901191.38693.37
4729624-72962496.77298.55
5725488-72548896.22498.18
6709109-70910994.05195.84
120min1725314-72531496.20199.771.9998.48102.121.98
2748616-74861699.291101.54
3752079-75207999.751102.24
4767638-767638101.814104.13
5762986-762986101.197103.69
6756604-756604100.351102.66
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1729530-72953096.76097.361.4299.57100.271.46
2736768-73676897.720100.52
3747019-74701999.079102.12
4723133-72313395.91198.79
5744583-74458398.756101.81
6723316-72331695.93698.80
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%
111.137553357566757550487545077675957578320.73
211.167606987593587600280.13
单位质量响应值RSD%判断
68089.1368102.870.02数据可信
供试品溶液-2024070521批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1101520-10152013.41811.939.8513.4211.949.86
290262-9026211.93011.93
393719-9371912.38612.39
483997-8399711.10211.10
595725-9572512.65212.65
676573-7657310.12010.12
10min1170182-17018222.49222.8710.8222.5722.9310.80
2173700-17370022.95723.02
3170658-17065822.55522.62
4159330-15933021.05821.12
5208406-20840627.54427.61
6155773-15577320.58820.64
15min1255950-25595033.82833.207.5934.0333.397.59
2250144-25014433.06133.25
3250557-25055733.11533.31
4235221-23522131.08831.27
5284540-28454037.60737.83
6230654-23065430.48530.66
20min1313567-31356741.44342.086.8341.8342.466.84
2319848-31984842.27342.65
3310659-31065941.05941.44
4308110-30811040.72241.07
5360214-36021447.60848.04
6297902-29790239.37339.71
30min1474088-47408862.65856.388.2363.2857.008.19
2450442-45044259.53360.15
3418037-41803755.25055.86
4379436-37943650.14950.73
5440258-44025858.18758.88
6397367-39736752.51953.08
45min1583624-58362477.13572.787.5478.1073.707.53
2546953-54695372.28973.23
3536833-53683370.95171.86
4517107-51710768.34469.20
5614540-61454081.22282.24
6504780-50478066.71567.57
60min1663760-66376087.72787.855.3889.1289.185.33
2709175-70917593.72995.07
3691046-69104691.33392.64
4666017-66601788.02589.26
5653419-65341986.36087.83
6604868-60486879.94381.16
90min1674542-67454289.15292.863.9291.0394.683.76
2689175-68917591.08692.95
3737459-73745997.46799.28
4712226-71222694.13295.86
5673599-67359989.02790.98
6728508-72850896.28497.95
120min1682509-68250990.20598.264.6192.58100.594.47
2755755-75575599.885102.26
3779674-779674103.047105.40
4761626-761626100.661102.91
5727498-72749896.15198.60
6753625-75362599.604101.80
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1727687-72768796.17697.622.7099.05100.502.61
2738933-73893397.662100.59
3767561-767561101.446104.37
4754274-75427499.690102.50
5711596-71159694.04997.03
6731528-73152896.68399.44
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