培哚普利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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.734110541092411254110041133411110.05
29.694127841180412290.17
单位质量响应值RSD%判断
4225.184254.800.50数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148828-4882899.36598.101.9799.3798.101.97
248582-4858298.86598.86
348831-4883199.37199.37
446470-4647094.56794.57
548786-4878699.28099.28
647735-4773597.14197.14
10min148498-4849898.69499.550.6299.80100.640.61
249188-49188100.098101.20
348620-4862098.942100.05
448941-4894199.595100.65
549234-49234100.192101.29
649039-4903999.795100.87
15min148804-4880499.31698.201.37101.52100.401.36
249149-49149100.019102.23
348036-4803697.75499.96
447273-4727396.20198.36
548271-4827198.232100.45
648005-4800597.69099.88
20min146769-4676995.17596.301.2598.4899.591.22
247650-4765096.968100.29
347675-4767597.019100.31
446424-4642494.47397.70
547509-4750996.68199.99
647911-4791197.499100.77
30min147017-4701795.68095.771.58100.04100.131.55
247354-4735496.366100.77
347930-4793097.538101.91
445834-4583493.27297.55
546665-4666594.96499.35
647569-4756996.803101.16
45min146367-4636794.35794.721.4199.78100.141.37
247317-4731796.290101.76
346114-4611493.84299.29
445626-4562692.84998.16
546613-4661394.858100.29
647228-4722896.109101.54
极限145728-4572893.05793.640.9599.53100.110.93
246109-4610993.832100.37
345973-4597393.555100.05
445581-4558192.75899.10
545877-4587793.36099.85
646813-4681395.265101.77
培哚普利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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.513739737290372583734537367373310.16
213.473764337402375220.46
单位质量响应值RSD%判断
2763.212785.600.58数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18297-829718.88224.1327.9118.8824.1327.91
27772-777217.68717.69
310791-1079124.55824.56
414983-1498334.09834.10
513241-1324130.13330.13
68537-853719.42819.43
10min120105-2010545.75451.0010.9945.9651.2711.04
219743-1974344.93045.13
324775-2477556.38256.65
425863-2586358.85859.24
521983-2198350.02850.36
622003-2200350.07450.29
15min124132-2413254.91960.089.6455.6460.919.66
224198-2419855.06955.76
329891-2989168.02568.92
429119-2911966.26867.30
524743-2474356.30957.20
626316-2631659.88960.66
20min125327-2532757.63864.209.9258.9765.709.93
225891-2589158.92260.23
331851-3185172.48574.14
430922-3092270.37172.14
526197-2619759.61861.13
629081-2908166.18267.62
30min127376-2737662.30170.059.3464.2772.269.37
228549-2854964.97166.93
334159-3415977.73880.20
433826-3382676.98079.53
529028-2902866.06168.24
631746-3174672.24774.42
45min128363-2836364.54873.479.0667.2176.469.10
230765-3076570.01472.70
336105-3610582.16785.49
435276-3527680.28083.69
531067-3106770.70173.61
632122-3212273.10276.08
极限130328-3032869.01977.518.5572.4081.328.61
232492-3249273.94477.41
337854-3785486.14790.38
437064-3706484.34988.65
532467-3246773.88777.59
634144-3414477.70481.49
培哚普利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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.734100741029410194116441171410780.20
29.694104040985410120.10
单位质量响应值RSD%判断
4221.794232.400.18数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149073-49073100.167100.421.53100.17100.421.53
248849-4884999.71099.71
350161-50161102.388102.39
449963-49963101.984101.98
548998-48998100.014100.01
648135-4813598.25398.25
10min147678-4767897.32098.741.5098.4399.861.49
248890-4889099.794100.90
347654-4765497.27198.41
448875-4887599.763100.90
549292-49292100.614101.73
647859-4785997.68998.78
15min146799-4679995.52696.911.1597.7299.121.14
248031-4803198.040100.26
347334-4733496.61898.84
447582-4758297.12499.37
548128-4812898.238100.47
646977-4697795.88998.07
20min146408-4640894.72895.961.5397.9899.251.50
246900-4690095.73299.04
346132-4613294.16497.46
447764-4776497.495100.82
547927-4792797.828101.15
646937-4693795.80799.05
30min145898-4589893.68795.211.6197.9999.561.58
247157-4715796.256100.63
345820-4582093.52797.87
447253-4725396.452100.86
547515-4751596.987101.39
646218-4621894.34098.65
45min145594-4559493.06693.901.3998.4299.321.37
246669-4666995.260100.70
345409-4540992.68898.07
446535-4653594.987100.46
546529-4652994.975100.46
645294-4529492.45497.81
极限144495-4449590.82392.501.3297.2198.961.30
245481-4548192.83599.33
345016-4501691.88698.29
445594-4559493.06699.60
546241-4624194.387100.93
645080-4508092.01798.40
培哚普利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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.513747437332374533748437330374150.21
213.473739137379373850.03
单位质量响应值RSD%判断
2769.432775.430.16数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141754-4175495.08997.162.7395.0997.162.73
243550-4355099.17999.18
344334-44334100.964100.96
443076-4307698.09998.10
541828-4182895.25795.26
641443-4144394.38094.38
10min142621-4262197.06396.221.7598.1297.301.73
241007-4100793.38894.49
342765-4276597.39198.51
443051-4305198.04299.13
541900-4190095.42196.48
642166-4216696.02797.08
15min141170-4117093.75994.052.2095.8996.192.18
240162-4016291.46393.60
342597-4259797.00899.21
441825-4182595.25097.43
540428-4042892.06994.19
641594-4159494.72496.84
20min140893-4089393.12893.222.5896.3096.412.53
239091-3909189.02492.18
341522-4152294.56097.84
442224-4222496.15999.40
540655-4065592.58695.73
641206-4120693.84197.01
30min140666-4066692.61192.442.0696.8296.672.04
239514-3951489.98794.13
341125-4112593.65697.99
441739-4173995.05599.36
539770-3977090.57094.74
640733-4073392.76496.97
45min140348-4034891.88791.132.2797.1396.392.24
238890-3889088.56693.71
340573-4057392.39997.77
441284-4128494.01899.38
539116-3911689.08194.26
639887-3988790.83796.08
极限139277-3927789.44889.722.2995.7195.992.25
237846-3784686.18992.32
340291-4029191.75798.16
440243-4024391.64898.05
539123-3912389.09795.26
639597-3959790.17696.43
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-07-23 15:12:51 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-07-23 15:13:06 完成)
Current page cost:55 ms