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%
110.779550395806953739521995201954200.27
210.829520295237952200.03
单位质量响应值RSD%判断
8859.808800.370.48数据可信
供试品溶液-25021701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%
5min134201-3420134.77936.342.7234.7836.342.72
234995-3499535.58735.59
336146-3614636.75736.76
435986-3598636.59536.59
536905-3690537.52937.53
636182-3618236.79436.79
10min140337-4033741.01942.371.6941.2142.581.69
242434-4243443.15243.35
341739-4173942.44542.65
441746-4174642.45242.66
541908-4190842.61742.83
641842-4184242.55042.75
15min143344-4334444.07744.601.3644.5045.041.36
243516-4351644.25244.69
345025-4502545.78646.23
443744-4374444.48444.92
543773-4377344.51344.96
643740-4374044.48044.92
20min142811-4281143.53544.651.3344.2045.331.33
243869-4386944.61145.29
344065-4406544.81045.50
444445-4444545.19745.88
543929-4392944.67245.36
644333-4433345.08345.77
30min142507-4250743.22645.192.3944.1346.122.37
244142-4414244.88845.82
344406-4440645.15746.10
445475-4547546.24447.18
544952-4495245.71246.65
645123-4512345.88646.82
45min143267-4326743.99945.651.8845.1546.841.87
245323-4532346.08947.27
345497-4549746.26647.46
444927-4492745.68746.88
544843-4484345.60146.80
645497-4549746.26647.46
60min142948-4294843.67445.582.7745.0747.022.71
246390-4639047.17448.61
343916-4391644.65946.11
444974-4497445.73547.18
544964-4496445.72447.17
645742-4574246.51647.97
90min144732-4473245.48846.501.2947.1248.191.29
245609-4560946.38048.08
345919-4591946.69648.39
446236-4623647.01848.72
546342-4634247.12648.83
645518-4551846.28848.00
120min143413-4341344.14745.683.1346.0347.633.03
246170-4617046.95148.91
345791-4579146.56548.52
445446-4544646.21548.18
545838-4583846.61348.58
642892-4289243.61745.58
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146294-4629447.07723.45109.5549.2125.65100.09
245759-4575946.53348.75
346298-4629847.08149.30
4-0.0002.22
5-0.0002.22
6-0.0002.21
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%
110.779620396424963140.17
210.829569695849957720.12
单位质量响应值RSD%判断
8942.808851.390.73数据可信
供试品溶液-25021702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%
5min136694-3669437.03439.935.1337.0339.935.13
239126-3912639.48939.49
338741-3874139.10039.10
439943-3994340.31340.31
539973-3997340.34340.34
642898-4289843.29543.30
10min143944-4394444.35144.491.2744.5644.721.26
245009-4500945.42645.65
344172-4417244.58144.80
443595-4359543.99944.22
544321-4432144.73244.96
643466-4346643.86944.11
15min143679-4367944.08444.961.0144.5445.431.02
244613-4461345.02645.50
344807-4480745.22245.69
444901-4490145.31745.79
544491-4449144.90345.38
644772-4477245.18745.67
20min145367-4536745.78745.281.4346.4846.001.40
243863-4386344.26944.99
345024-4502445.44146.16
444301-4430144.71145.43
545258-4525845.67746.40
645397-4539745.81846.55
30min145700-4570046.12345.731.5247.0746.701.50
244685-4468545.09946.07
344568-4456844.98145.95
445574-4557445.99646.96
544994-4499445.41146.39
646358-4635846.78847.78
45min145374-4537445.79446.671.5747.0047.901.55
245754-4575446.17847.40
346901-4690147.33648.55
445661-4566146.08447.31
546748-4674847.18148.41
647022-4702247.45848.71
60min146727-4672747.16047.322.0048.6248.811.96
247382-4738247.82149.30
346295-4629546.72448.21
445871-4587146.29647.78
546554-4655446.98548.48
648507-4850748.95650.47
90min147279-4727947.71748.272.3149.4450.022.27
247619-4761948.06049.80
347481-4748147.92149.66
447375-4737547.81449.55
547160-4716047.59749.35
650059-5005950.52352.31
120min148888-4888849.34148.492.4051.3350.502.34
248051-4805148.49650.50
347102-4710247.53849.55
446902-4690247.33749.34
547441-4744147.88149.90
649879-4987950.34152.41
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148689-4868949.14040.4049.0551.4042.6846.34
247136-4713647.57349.85
349374-4937449.83252.10
447094-4709447.53049.80
547866-4786648.31050.59
6-0.0002.35
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%
110.779662996372964619652596585965140.11
210.829528395297952900.02
单位质量响应值RSD%判断
8961.378806.841.23数据可信
供试品溶液-4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%
5min136606-3660637.00137.112.2137.0037.112.22
235638-3563836.02336.02
336070-3607036.45936.46
437734-3773438.14138.14
536713-3671337.10937.11
637531-3753137.93637.94
10min142718-4271843.17942.850.9743.3843.060.97
242068-4206842.52242.72
342149-4214942.60442.81
441930-4193042.38242.59
542554-4255443.01343.22
642962-4296243.42643.64
15min142901-4290143.36443.851.1943.8144.291.17
244123-4412344.59945.04
343543-4354344.01344.45
442786-4278643.24843.70
543184-4318443.65044.10
643736-4373644.20844.66
20min143509-4350943.97944.731.0544.6645.411.04
243988-4398844.46345.15
344332-4433244.81045.49
444613-4461345.09445.78
544232-4423244.70945.40
644813-4481345.29745.99
30min142300-4230042.75644.111.7643.6945.051.73
243515-4351543.98544.92
343839-4383944.31245.24
444273-4427344.75145.69
543469-4346943.93844.87
644452-4445244.93245.88
45min142727-4272743.18845.543.2944.3646.723.23
244707-4470745.18946.36
344717-4471745.20046.38
445787-4578746.28147.47
545136-4513645.62346.80
647237-4723747.74748.95
60min143562-4356244.03245.251.5945.4446.681.58
244782-4478245.26546.69
344815-4481545.29946.73
445027-4502745.51346.96
544641-4464145.12346.56
645753-4575346.24747.71
90min143398-4339843.86645.121.8745.5246.811.83
243796-4379644.26945.95
345386-4538645.87647.56
445086-4508645.57347.27
545244-4524445.73247.42
644944-4494445.42947.15
120min143409-4340943.87745.812.2445.7747.742.18
246400-4640046.90148.82
345511-4551146.00247.94
445786-4578646.28048.23
545517-4551746.00847.95
645275-4527545.76447.74
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144295-4429544.77345.671.3646.9147.861.34
244721-4472145.20447.39
346051-4605146.54848.74
445296-4529645.78547.99
545234-4523445.72247.92
645492-4549245.98348.21
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