XXYYYY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
120min143413-4341344.14746.272.3546.0348.222.32
246170-4617046.95148.91
345791-4579146.56548.52
445446-4544646.21548.18
546329-4632947.11249.08
645838-4583846.61348.58
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142892-4289243.61746.132.9445.7548.342.87
246294-4629447.07749.29
346113-4611346.89349.11
445759-4575946.53348.75
546298-4629847.08149.31
644834-4483445.59247.82
XXYYYY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%
110.779620396584963119642496600964240.18
210.829569695849957720.12
单位质量响应值RSD%判断
8953.028851.390.81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%
5min136694-3669437.01339.023.3737.0139.023.38
237647-3764737.97437.97
339126-3912639.46639.47
438741-3874139.07839.08
539943-3994340.29040.29
639973-3997340.32140.32
10min142898-4289843.27144.371.6243.4844.591.62
243944-4394444.32644.54
345009-4500945.40045.62
444172-4417244.55644.77
543595-4359543.97444.20
644321-4432144.70644.93
15min143466-4346643.84444.711.3744.2945.181.37
243679-4367944.05944.52
344613-4461345.00145.47
444807-4480745.19745.66
544901-4490145.29145.76
644491-4449144.87845.35
20min144772-4477245.16145.151.3145.8545.861.27
245367-4536745.76146.46
343863-4386344.24444.97
445024-4502445.41546.13
544301-4430144.68645.41
645258-4525845.65146.37
30min145397-4539745.79245.551.0546.7346.511.02
245700-4570046.09747.05
344685-4468545.07346.04
444568-4456844.95545.92
545574-4557445.97046.94
644994-4499445.38546.36
45min146358-4635846.76146.531.3647.9647.751.33
245374-4537445.76846.98
345754-4575446.15247.37
446901-4690147.30948.53
545661-4566146.05847.28
646748-4674847.15448.38
60min147022-4702247.43147.051.1548.8948.521.10
246727-4672747.13348.60
347382-4738247.79449.27
446295-4629546.69748.18
545871-4587146.27047.75
646554-4655446.95948.45
90min148507-4850748.92947.981.0350.6549.720.98
247279-4727947.69049.42
347619-4761948.03349.77
447481-4748147.89449.63
547375-4737547.78749.52
647160-4716047.57049.32
120min150059-5005950.49448.492.5252.4850.502.41
248888-4888849.31351.31
348051-4805148.46950.48
447102-4710247.51149.52
546902-4690247.31049.31
647441-4744147.85349.87
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149879-4987950.31348.762.4252.5851.032.30
248689-4868949.11251.38
347136-4713647.54649.82
449374-4937449.80352.07
547094-4709447.50349.77
647866-4786648.28250.56
XXYYYY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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