苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%) 96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.058485285090849668490184666848950.19
2 14.038543685301853680.12
单位质量响应值RSD%判断
6042.356084.680.50数据可信
供试品溶液-FX3469批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min146351-4635153.18759.4410.5753.1959.4410.57
251048-5104858.57658.58
356476-5647664.80564.80
444270-4427050.79950.80
556274-5627464.57364.57
656385-5638564.70064.70
10min163533-6353372.90372.934.5273.4373.524.55
265070-6507074.66675.25
366141-6614175.89576.54
458348-5834866.95367.46
565629-6562975.30875.95
662631-6263171.86872.51
15min168394-6839478.48077.203.4279.7478.523.44
269553-6955379.81081.14
369130-6913079.32580.73
463369-6336972.71473.89
567086-6708676.98078.38
666142-6614275.89677.26
20min169903-6990380.21281.042.1382.2683.142.07
271780-7178082.36684.50
372508-7250883.20185.40
471465-7146582.00483.91
568674-6867478.80280.97
669440-6944079.68181.81
30min173953-7395384.85983.053.2487.7185.953.22
273859-7385984.75187.71
374647-7464785.65688.69
468359-6835978.44081.17
572196-7219682.84385.80
671220-7122081.72384.64
45min175417-7541786.53985.712.8290.2489.442.83
275219-7521986.31290.11
377977-7797789.47793.37
471650-7165082.21785.73
574221-7422185.16788.95
673657-7365784.52088.26
60min175432-7543286.55686.531.8691.1291.121.84
273687-7368784.55489.22
376072-7607287.29192.07
473948-7394884.85489.18
575881-7588187.07291.71
677420-7742088.83893.42
极限181449-8144993.46192.092.5498.8997.542.34
278727-7872790.33795.85
379413-7941391.12596.78
481006-8100692.95298.13
577668-7766889.12294.63
683241-8324195.517100.99
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%) 96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.058505585026852368526085120851390.13
2 14.038568985538856140.13
单位质量响应值RSD%判断
6059.726102.210.50数据可信
供试品溶液-FX3469批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min147699-4769954.57648.9715.5754.5848.9715.58
234227-3422739.16239.16
347611-4761154.47654.48
435094-3509440.15440.15
549272-4927256.37656.38
642883-4288349.06649.07
10min161531-6153170.40366.0711.6970.9566.5611.70
252696-5269660.29460.69
362613-6261371.64172.19
446980-4698053.75454.16
564676-6467674.00174.56
657987-5798766.34866.84
15min170072-7007280.17573.5811.9881.4274.7311.99
258386-5838666.80467.80
368972-6897278.91780.18
452566-5256660.14561.08
572522-7252282.97884.28
663341-6334172.47473.63
20min173385-7338583.96678.0110.7586.0279.9010.79
263592-6359272.76174.42
373117-7311783.65985.71
456163-5616364.26165.80
575322-7532286.18288.32
667521-6752177.25679.14
30min178800-7880090.16283.5010.3693.0586.1710.41
269233-6923379.21581.61
379003-7900390.39493.28
460180-6018068.85771.04
578980-7898090.36893.36
671686-7168682.02284.67
45min181195-8119592.90288.848.0596.6992.348.17
275295-7529586.15189.33
382278-8227894.14197.93
466022-6602275.54178.41
581909-8190993.71997.62
679196-7919690.61594.09
60min180767-8076792.41290.466.2197.1394.856.37
279121-7912190.52994.57
381547-8154793.30598.04
469299-6929979.29182.92
582446-8244694.33399.17
681185-8118592.89197.27
极限182491-8249194.38594.521.56100.0399.811.42
281589-8158993.35398.30
383299-8329995.309100.97
483308-8330895.32099.74
580715-8071592.35398.13
684233-8423396.378101.68
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%) 96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)5供试品稀释倍数10系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.058535585334852588539585199853080.10
2 14.038602085989860040.03
单位质量响应值RSD%判断
6071.746130.010.68数据可信
供试品溶液-FX3469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%
5min120987-2098723.93525.2312.0123.9325.2312.00
220266-2026623.11323.11
320165-2016522.99723.00
420978-2097823.92523.92
527010-2701030.80430.80
623345-2334526.62426.62
10min133137-3313737.79138.277.1738.0338.537.19
232432-3243236.98737.22
331180-3118035.56035.79
433918-3391838.68238.92
538112-3811243.46543.77
632587-3258737.16437.43
15min140496-4049646.18445.556.5546.8046.186.58
239038-3903844.52145.12
336957-3695742.14842.73
439840-3984045.43646.06
544675-4467550.95051.69
638617-3861744.04144.68
20min145220-4522051.57251.324.6052.6552.414.66
244251-4425150.46751.51
342806-4280648.81949.83
444488-4448850.73751.82
548897-4889755.76557.02
644310-4431050.53451.61
30min152911-5291160.34357.716.2861.9459.326.28
248749-4874955.59657.15
347868-4786854.59256.09
449270-4927056.19057.78
556014-5601463.88265.69
648816-4881655.67357.26
45min160541-6054169.04565.704.1671.2467.884.19
255552-5555263.35565.46
355387-5538763.16765.21
457835-5783565.95968.11
560416-6041668.90271.35
655892-5589263.74365.88
60min165903-6590375.16071.184.1578.0574.024.17
261377-6137769.99872.74
358974-5897467.25869.93
461758-6175870.43373.24
565049-6504974.18677.32
661415-6141570.04172.82
极限183753-8375395.51794.393.4799.1697.943.50
283456-8345695.17898.62
378680-7868089.73193.08
480228-8022891.49795.01
586701-8670198.879102.76
683787-8378795.55699.03
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