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%
116.257784077955778437786177852778700.07
216.287891279081789960.16
单位质量响应值RSD%判断
4792.004852.330.89数据可信
供试品溶液-2024032201-2-YD1批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117788-1778820.70919.835.8820.7119.835.89
216623-1662319.35319.35
318124-1812421.10021.10
415301-1530117.81317.81
517308-1730820.15020.15
617058-1705819.85919.86
10min134737-3473740.44140.492.6540.6740.722.62
234188-3418839.80240.02
333383-3338338.86539.10
435769-3576941.64241.84
535752-3575241.62241.85
634870-3487040.59640.82
15min146127-4612753.70154.522.4454.3855.192.43
246356-4635653.96854.62
347568-4756855.37956.04
445124-4512452.53353.19
548046-4804655.93556.62
647765-4776555.60856.28
20min154571-5457163.53264.701.9764.8165.971.95
254821-5482163.82365.08
356445-5644565.71366.99
454903-5490363.91865.16
557336-5733666.75168.06
655355-5535564.44465.73
30min165487-6548776.24077.611.5478.2279.601.54
266448-6644877.35979.32
366828-6682877.80179.81
466090-6609076.94278.90
568526-6852679.77881.83
666579-6657977.51179.52
45min172293-7229384.16487.141.9486.9990.001.91
274810-7481087.09489.92
375463-7546387.85490.73
474817-7481787.10289.91
576723-7672389.32192.26
675008-7500887.32490.19
60min177451-7745190.16891.170.8593.9394.990.88
277986-7798690.79194.58
378224-7822491.06894.92
478046-7804690.86194.64
579301-7930192.32296.25
678843-7884391.78995.63
极限179536-7953692.59693.061.1197.3697.891.11
279719-7971992.80997.61
379294-7929492.31497.18
479769-7976992.86797.65
581709-8170995.126100.08
679563-7956392.62797.48
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%
116.257829578330783117837978376783380.05
216.287949479862796780.33
单位质量响应值RSD%判断
4820.804894.231.07数据可信
供试品溶液-2024032201-2-YD2批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116626-1662619.21519.193.8119.2219.193.81
216611-1661119.19819.20
316733-1673319.33919.34
416134-1613418.64718.65
515824-1582418.28918.29
617678-1767820.43120.43
10min133849-3384939.12139.365.2239.3339.575.20
231446-3144636.34436.56
334150-3415039.46939.68
434722-3472240.13040.34
533309-3330938.49738.70
636866-3686642.60842.83
15min146345-4634553.56354.072.1354.2154.722.15
246363-4636353.58454.20
346258-4625853.46354.12
447117-4711754.45555.11
545948-4594853.10453.74
648648-4864856.22556.93
20min154392-5439262.86464.182.5064.1165.442.50
254589-5458963.09164.30
354701-5470163.22164.47
456745-5674565.58366.84
555018-5501863.58764.81
657758-5775866.75468.08
30min163893-6389373.84475.332.6375.7977.302.63
263742-6374273.67075.58
364354-6435474.37776.33
467164-6716477.62579.61
564375-6437574.40176.33
667567-6756778.09180.16
45min172554-7255483.85484.272.2786.6287.072.27
270508-7050881.49084.22
372686-7268684.00786.78
475198-7519886.91089.76
572205-7220583.45186.21
674327-7432785.90388.84
60min176529-7652988.44889.231.4792.1492.971.49
276262-7626288.14091.78
377023-7702389.01992.73
479356-7935691.71695.53
576604-7660488.53592.22
677456-7745689.52093.41
极限178533-7853390.76591.441.1695.4496.171.16
278827-7882791.10495.72
379206-7920691.54296.24
480903-8090393.50498.34
578449-7844990.66795.33
678790-7879091.06295.95
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%
116.257869378528790957896879091788750.33
216.287986679966799160.09
单位质量响应值RSD%判断
4853.854908.850.80数据可信
供试品溶液-2024032201-2-YD3批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16273-62737.2148.8118.437.218.8118.43
26604-66047.5957.60
37857-78579.0369.04
410224-1022411.75811.76
57837-78379.0139.01
67144-71448.2168.22
10min121540-2154024.77328.6411.2324.8528.7411.25
222729-2272926.14026.22
326785-2678530.80530.91
429210-2921033.59433.72
525179-2517928.95829.06
623979-2397927.57827.67
15min135037-3503740.29544.447.2340.6544.867.28
236034-3603441.44241.82
340510-4051046.59047.03
442527-4252748.90949.41
539377-3937745.28745.71
638383-3838344.14344.54
20min145362-4536252.17056.395.6652.9757.305.73
246733-4673353.74754.58
350919-5091958.56159.52
452823-5282360.75161.80
550125-5012557.64858.57
648242-4824255.48256.37
30min159891-5989168.87971.702.8470.2673.242.95
261265-6126570.46071.89
363306-6330672.80774.42
464736-6473674.45176.17
563372-6337272.88374.45
661488-6148870.71672.22
45min172139-7213982.96584.291.7985.1186.621.88
271388-7138882.10284.32
374705-7470585.91788.34
474473-7447385.65088.20
573312-7331284.31586.69
673720-7372084.78487.07
60min177148-7714888.72690.651.2091.8093.921.31
278440-7844090.21293.34
378890-7889090.73094.10
479804-7980491.78195.28
579470-7947091.39794.71
679181-7918191.06494.30
极限179404-7940491.32192.941.3695.3897.211.47
280135-8013592.16196.29
381563-8156393.80498.19
482334-8233494.69199.21
581287-8128793.48697.81
680129-8012992.15596.40
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