托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001对照品来源工作对照品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10000
标示量(mg)15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%
116.719800498043979539795097945979790.05
216.779907299324991980.18
单位质量响应值RSD%判断
5863.495915.210.63数据可信
供试品溶液-24053001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%
5min113407-1340713.63214.665.3513.6314.665.36
214004-1400414.23914.24
315379-1537915.63715.64
415287-1528715.54315.54
514285-1428514.52514.52
614128-1412814.36514.36
10min122991-2299123.37724.454.7223.4524.534.73
222808-2280823.19023.27
324345-2434524.75324.84
425954-2595426.38926.48
524252-2425224.65924.74
623941-2394124.34224.42
15min129882-2988230.38331.022.9630.5931.242.97
229959-2995930.46130.67
330814-3081431.33131.56
432173-3217332.71332.95
530392-3039230.90231.12
629814-2981430.31430.53
20min135829-3582936.43036.292.3736.8036.682.37
235457-3545736.05236.43
335941-3594136.54436.94
437147-3714737.77038.18
534831-3483135.41535.80
634935-3493535.52135.90
30min140217-4021740.89142.743.0541.4743.333.04
241297-4129741.99042.57
342392-4239243.10343.70
444053-4405344.79245.42
541895-4189542.59843.18
642368-4236843.07943.66
45min146105-4610546.87850.203.5047.6851.033.48
250008-5000850.84751.66
349539-4953950.37051.21
451235-5123552.09452.97
549945-4994550.78351.61
649415-4941550.24451.06
60min153820-5382054.72357.052.5455.7958.162.53
257247-5724758.20759.30
355620-5562056.55357.67
457912-5791258.88360.05
556202-5620257.14558.25
655879-5587956.81657.92
90min159292-5929260.28664.443.5761.6565.863.55
263123-6312364.18265.60
363759-6375964.82866.26
466197-6619767.30768.80
563759-6375964.82866.25
664130-6413065.20566.62
120min166508-6650867.62369.323.0669.3371.113.04
267710-6771068.84670.62
368717-6871769.86971.66
471951-7195173.15875.02
568054-6805469.19570.98
666147-6614767.25669.03
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169503-6950370.66974.073.8272.7576.243.77
271002-7100272.19374.35
377078-7707878.37180.55
474930-7493076.18778.46
573099-7309974.32576.49
671500-7150072.69974.85
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001对照品来源工作对照品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10000
标示量(mg)15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%
116.719799598150981999810998038980980.09
216.771002051005661003860.26
单位质量响应值RSD%判断
5870.625986.051.38数据可信
供试品溶液-24053002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%
5min114035-1403514.17814.562.5114.1814.562.50
214154-1415414.29814.30
314593-1459314.74114.74
414098-1409814.24114.24
514865-1486515.01615.02
614735-1473514.88514.88
10min123365-2336523.60223.821.0323.6823.901.04
223259-2325923.49523.57
323514-2351423.75323.83
423733-2373323.97424.05
523861-2386124.10324.19
623777-2377724.01924.10
15min129173-2917329.46929.912.7229.6830.132.70
229351-2935129.64929.86
328967-2896729.26129.48
429559-2955929.85930.07
529425-2942529.72429.94
631198-3119831.51531.73
20min133249-3324933.58734.232.2633.9634.612.25
232766-3276633.09933.47
334335-3433534.68435.06
434665-3466535.01735.40
534550-3455034.90135.28
633764-3376434.10734.50
30min139925-3992540.33139.624.6240.8940.194.55
238228-3822838.61639.17
340323-4032340.73341.30
439563-3956339.96540.54
536116-3611636.48337.06
641196-4119641.61542.20
45min143718-4371844.16246.525.0644.9547.314.99
243228-4322843.66744.44
347326-4732647.80748.60
449332-4933249.83350.63
547105-4710547.58448.36
645613-4561346.07646.89
60min151743-5174352.26953.051.9553.3054.101.94
251426-5142651.94952.96
352726-5272653.26254.32
454207-5420754.75855.83
553004-5300453.54354.59
651974-5197452.50253.57
90min159019-5901959.61961.232.9360.9462.582.90
259285-5928559.88761.19
359754-5975460.36161.72
463841-6384164.49065.87
561107-6110761.72863.07
660685-6068561.30262.66
120min164885-6488565.54466.531.8667.2068.211.86
264794-6479465.45267.09
366529-6652967.20568.90
467833-6783368.52270.26
564910-6491065.57067.25
666195-6619566.86868.57
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169349-6934970.05470.903.4672.0772.953.42
267013-6701367.69469.69
371660-7166072.38874.45
474068-7406874.82176.94
568999-6899969.70071.75
670030-7003070.74272.81
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