玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.089854798760990699904098619988070.25
211.169977499816997950.03
单位质量响应值RSD%判断
8917.608942.200.20数据可信
供试品溶液-N0001N04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%
5min113874-1387413.95111.9628.6813.9511.9628.68
27716-77167.7597.76
316434-1643416.52516.52
411502-1150211.56611.57
58258-82588.3048.30
613563-1356313.63813.64
10min130585-3058530.75426.8313.6830.9126.9613.75
222911-2291123.03823.12
330479-3047930.64830.83
424919-2491925.05725.19
522663-2266322.78822.88
628549-2854928.70728.86
15min137070-3707037.27535.446.2437.7735.876.35
234508-3450834.69935.04
337409-3740937.61638.14
433067-3306733.25033.66
532443-3244332.62332.97
636976-3697637.18137.65
20min139341-3934139.55939.323.9240.4740.144.01
239395-3939539.61340.34
340490-4049040.71441.66
436828-3682837.03237.81
537782-3778237.99138.70
640763-4076340.98941.87
30min143698-4369843.94043.382.6545.2944.642.72
243420-4342043.66044.83
343858-4385844.10145.50
440878-4087841.10442.29
543151-4315143.39044.52
643847-4384744.09045.43
45min144496-4449644.74246.302.4546.5848.042.40
246704-4670446.96248.62
347780-4778048.04449.93
445467-4546745.71947.36
546162-4616246.41748.03
645660-4566045.91347.74
60min147225-4722547.48647.321.9749.8249.581.76
248129-4812948.39550.57
345445-4544545.69648.11
446651-4665146.90949.06
547396-4739647.65849.79
647507-4750747.77050.11
90min147993-4799348.25948.761.1451.1251.540.94
248848-4884849.11851.83
348442-4844248.71051.64
448387-4838748.65551.33
549379-4937949.65252.31
647904-4790448.16951.04
120min148437-4843748.70549.231.1952.1052.561.23
249077-4907749.34952.61
349334-4933449.60753.07
448216-4821648.48351.70
548912-4891249.18352.39
649801-4980150.07753.48
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149089-4908949.36150.231.3953.3054.101.26
250591-5059150.87154.68
350233-5023350.51154.53
449279-4927949.55253.30
550778-5077851.05954.81
649772-4977250.04754.01
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.089918499254994079919599085992250.12
211.169979899830998140.03
单位质量响应值RSD%判断
8955.328943.910.10数据可信
供试品溶液-N0001N04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%
5min18505-85058.53312.7125.658.5312.7125.67
29611-96119.6439.64
314429-1442914.47714.48
411532-1153211.57011.57
515877-1587715.93015.93
616045-1604516.09816.10
10min125896-2589625.98227.967.1426.0828.107.23
225647-2564725.73225.84
329228-2922829.32529.49
426747-2674726.83626.96
529750-2975029.84930.03
629936-2993630.03530.21
15min135298-3529835.41536.204.0135.8036.664.11
233963-3396334.07634.47
336739-3673936.86137.35
435394-3539435.51135.94
537302-3730237.42637.93
637802-3780237.92738.44
20min139925-3992540.05740.162.0040.8341.022.10
238882-3888239.01139.78
340889-4088941.02541.92
439444-3944439.57540.40
540908-4090841.04441.97
640128-4012840.26141.20
30min144573-4457344.72144.762.1145.9446.062.20
243425-4342543.56944.77
345009-4500945.15846.51
443610-4361043.75545.02
545256-4525645.40646.79
645801-4580145.95347.33
45min146812-4681246.96747.341.1548.6949.141.21
246642-4664246.79748.49
346705-4670546.86048.71
447697-4769747.85549.60
547352-4735247.50949.39
647902-4790248.06149.95
60min146942-4694247.09848.111.8449.3450.431.88
248093-4809348.25350.46
347372-4737247.52949.90
447337-4733747.49449.77
549129-4912949.29251.70
648815-4881548.97751.40
90min149282-4928249.44549.221.0952.2152.081.00
249012-4901249.17551.92
349689-4968949.85452.76
449068-4906849.23152.04
548081-4808148.24051.20
649193-4919349.35652.33
120min148004-4800448.16349.631.5751.4853.031.56
249527-4952749.69152.98
349348-4934849.51252.97
450163-5016350.32953.68
549741-4974149.90653.40
649997-4999750.16353.68
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148836-4883648.99849.792.7552.8553.742.67
249087-4908749.25053.09
349526-4952649.69053.70
448771-4877148.93352.85
549160-4916049.32353.37
652343-5234352.51756.59
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081003871003981002281000721000931002360.16
211.169971499641996780.06
单位质量响应值RSD%判断
9046.578931.720.91数据可信
供试品溶液-N0001N04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%
5min19420-94209.41014.1821.239.4114.1821.22
212736-1273612.72312.72
317271-1727117.25317.25
415169-1516915.15315.15
513322-1332213.30813.31
617237-1723717.21917.22
10min127463-2746327.43429.133.7127.5429.283.79
228343-2834328.31328.45
330285-3028530.25330.44
429146-2914629.11529.28
529715-2971529.68429.83
629997-2999729.96530.16
15min134835-3483534.79835.892.1835.2136.372.25
235097-3509735.06035.52
336694-3669436.65537.18
435999-3599935.96136.45
536466-3646636.42836.91
636455-3645536.41736.94
20min138481-3848138.44039.151.1639.2440.031.24
238950-3895038.90939.75
339100-3910039.05939.99
439449-3944939.40740.30
539382-3938239.34040.22
639788-3978839.74640.67
30min141740-4174041.69642.411.3042.9243.721.35
242689-4268942.64443.92
342781-4278142.73644.10
441934-4193441.89043.22
542369-4236942.32443.64
643207-4320743.16144.53
45min143795-4379543.74943.881.2345.4445.671.27
243513-4351343.46745.22
344229-4422944.18246.03
443689-4368943.64345.44
543466-4346643.42045.21
644876-4487644.82946.68
60min144170-4417044.12344.710.9346.3046.990.98
244971-4497144.92447.16
344587-4458744.54046.87
444597-4459744.55046.83
544848-4484844.80147.07
645393-4539345.34547.69
90min145947-4594745.89945.692.4148.5648.462.33
243576-4357643.53046.26
346388-4638846.33949.17
445761-4576145.71348.49
546611-4661146.56249.33
646152-4615246.10348.96
120min145944-4594445.89645.750.4449.0749.020.49
245463-4546345.41548.63
345928-4592845.88049.22
445637-4563745.58948.87
545870-4587045.82249.11
645934-4593445.88649.25
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145188-4518845.14045.671.4448.8249.451.39
245016-4501644.96948.69
346102-4610246.05349.91
446630-4663046.58150.37
546117-4611746.06849.86
645236-4523645.18849.06
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