玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40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%
111.189798398379985519849698402983620.23
211.239834098130982350.16
单位质量响应值RSD%判断
8798.038747.550.41数据可信
供试品溶液-2025062621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%
5min134383-3438335.19335.461.5335.1935.461.53
235376-3537636.20936.21
335038-3503835.86335.86
434160-3416034.96434.96
534851-3485135.67235.67
634048-3404834.85034.85
10min140527-4052741.48141.191.0841.6841.391.09
240199-4019941.14641.35
340757-4075741.71741.92
440033-4003340.97641.17
540408-4040841.36041.56
639518-3951840.44940.64
15min143036-4303644.04943.811.0644.4844.241.06
242849-4284943.85844.29
342949-4294943.96044.39
442507-4250743.50843.93
543382-4338244.40444.83
642081-4208143.07243.49
20min144911-4491145.96944.742.2046.6445.412.17
244207-4420745.24845.92
344052-4405245.08945.76
442184-4218443.17743.84
543047-4304744.06144.74
643863-4386344.89645.55
30min145336-4533646.40447.041.0647.3347.961.03
245337-4533746.40547.33
346226-4622647.31548.24
446370-4637047.46248.37
546308-4630847.39848.32
646145-4614547.23248.14
45min146726-4672647.82648.480.8649.0149.660.83
247628-4762848.75049.93
347256-4725648.36949.56
447344-4734448.45949.63
547278-4727848.39149.57
647931-4793149.06050.23
60min148170-4817049.30449.101.2050.7550.551.15
248394-4839449.53450.99
347429-4742948.54650.00
448181-4818149.31650.75
547106-4710648.21549.67
648549-4854949.69251.13
90min146760-4676047.86149.412.0849.5851.132.01
248589-4858949.73351.46
347274-4727448.38750.11
449036-4903650.19151.90
548914-4891450.06651.79
649063-4906350.21851.94
120min148058-4805849.19049.660.7751.1851.650.74
248614-4861449.75951.76
349161-4916150.31952.31
448475-4847549.61651.61
548483-4848349.62551.62
648298-4829849.43551.43
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148706-4870649.85350.411.6052.1252.681.53
248793-4879349.94252.22
349045-4904550.20052.48
449013-4901350.16752.43
550823-5082352.02054.29
649115-4911550.27252.54
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40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%
111.189826398720987789876298880986810.25
211.239841398812986120.29
单位质量响应值RSD%判断
8826.578781.120.37数据可信
供试品溶液-2025062621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%
5min132683-3268333.33533.952.2333.3333.952.23
232513-3251333.16133.16
332820-3282033.47433.47
433403-3340334.06934.07
534319-3431935.00335.00
633986-3398634.66434.66
10min139312-3931240.09639.621.4340.2839.811.42
239094-3909439.87340.06
338194-3819438.95539.14
438852-3885239.62739.82
538166-3816638.92739.12
639449-3944940.23540.43
15min140957-4095741.77442.011.4242.1842.421.42
240813-4081341.62742.03
340849-4084941.66342.07
440691-4069141.50241.91
541665-4166542.49642.91
642140-4214042.98043.40
20min143193-4319344.05444.682.3344.6945.322.31
242616-4261643.46644.10
343997-4399744.87445.51
443560-4356044.42845.07
545625-4562546.53547.18
643865-4386544.74045.39
30min144142-4414245.02246.241.4745.9147.121.45
245172-4517246.07346.95
345460-4546046.36647.25
445605-4560546.51447.40
545471-4547146.37847.28
646139-4613947.05947.96
45min146732-4673247.66448.011.4148.8049.161.38
246241-4624147.16348.30
347744-4774448.69649.84
447912-4791248.86750.01
547211-4721148.15249.32
646615-4661547.54448.71
60min147545-4754548.49349.381.1249.8950.791.09
248982-4898249.95951.35
349006-4900649.98351.39
448283-4828349.24650.66
548307-4830749.27050.70
648342-4834249.30650.73
90min147246-4724648.18849.692.9949.8651.382.91
247462-4746248.40850.08
349723-4972350.71452.40
448837-4883749.81151.50
548030-4803048.98850.69
651029-5102952.04653.75
120min148751-4875149.72350.231.0351.6652.191.01
248887-4888749.86251.80
350132-5013251.13153.10
448970-4897049.94651.91
549412-4941250.39752.37
649345-4934550.32952.32
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148813-4881349.78650.031.7252.0052.281.65
248877-4887749.85152.07
347691-4769148.64250.90
450139-5013951.13953.38
549698-4969850.68952.95
649113-4911350.09252.36
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40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%
111.189833698412983819865298248984060.16
211.239870999136989220.31
单位质量响应值RSD%判断
8801.978808.730.06数据可信
供试品溶液-2025062721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%
5min133819-3381934.48735.572.8034.4935.572.79
233680-3368034.34534.35
335533-3553336.23536.23
435195-3519535.89035.89
534908-3490835.59835.60
636165-3616536.87936.88
10min140247-4024741.04241.231.2341.2341.431.23
240596-4059641.39841.59
339645-3964540.42840.63
440425-4042541.22441.42
540527-4052741.32841.53
641158-4115841.97142.18
15min142849-4284943.69643.930.9844.1244.360.98
243179-4317944.03244.45
342639-4263943.48143.91
443029-4302943.87944.31
542910-4291043.75844.19
643855-4385544.72145.16
20min144755-4475545.63945.821.7146.3046.491.68
246314-4631447.22947.89
344634-4463445.51646.18
444573-4457345.45446.13
544095-4409544.96645.64
645196-4519646.08946.78
30min144410-4441045.28746.332.0246.2047.251.99
245104-4510445.99546.92
345304-4530446.19947.12
447093-4709348.02348.95
544994-4499445.88346.80
645686-4568646.58947.53
45min145823-4582346.72847.281.0347.9048.461.03
245961-4596146.86948.05
346165-4616547.07748.25
446557-4655747.47748.67
546538-4653847.45748.63
647123-4712348.05449.26
60min146708-4670847.63148.281.6049.0649.731.56
247768-4776848.71250.16
347327-4732748.26249.70
448643-4864349.60451.06
546714-4671447.63749.08
646937-4693747.86449.33
90min147701-4770148.64349.692.1250.3451.402.05
248241-4824149.19450.91
348287-4828749.24150.95
448243-4824349.19650.93
550519-5051951.51753.22
649351-4935150.32652.06
120min147259-4725948.19349.481.8850.1551.471.84
247556-4755648.49550.48
349313-4931350.28752.27
449416-4941650.39252.40
548655-4865549.61651.61
648949-4894949.91651.93
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148385-4838549.34149.961.7551.5752.221.70
247988-4798848.93651.19
348692-4869249.65451.91
449787-4978750.77153.05
550229-5022951.22153.49
648843-4884349.80852.10
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