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%
111.211011841012711009491010931013021011600.15
211.201017891010931014410.49
单位质量响应值RSD%判断
9024.099057.230.26数据可信
供试品溶液-B2022B01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%
5min137753-3775337.49739.443.9137.5039.443.90
239262-3926238.99639.00
341943-4194341.65841.66
440839-4083940.56240.56
538439-3843938.17838.18
640034-4003439.76239.76
10min146503-4650346.18845.731.5246.4045.951.51
247045-4704546.72646.94
345871-4587145.56045.79
444973-4497344.66844.89
545822-4582245.51145.72
646050-4605045.73845.96
15min146377-4637746.06247.271.4946.5347.741.48
247710-4771047.38647.86
348343-4834348.01548.50
448162-4816247.83548.31
547274-4727446.95347.42
647666-4766647.34347.82
20min150243-5024349.90249.390.9850.6250.120.98
249671-4967149.33450.07
350204-5020449.86350.61
449584-4958449.24849.99
548910-4891048.57849.30
649764-4976449.42650.16
30min150145-5014549.80550.171.3050.8051.181.27
250647-5064750.30351.32
350192-5019249.85250.88
449682-4968249.34550.36
550845-5084550.50051.50
651558-5155851.20852.22
45min153550-5355053.18752.302.0554.4653.592.00
251074-5107450.72852.02
354135-5413553.76855.07
452199-5219951.84553.13
552652-5265252.29553.57
652326-5232651.97153.27
60min152953-5295352.59452.381.7054.1653.961.65
252286-5228651.93153.51
352192-5219251.83853.44
451690-5169051.33952.91
553069-5306952.70954.28
654231-5423153.86355.45
90min154585-5458554.21553.941.4356.0855.821.39
253098-5309852.73854.60
355021-5502154.64856.54
453922-5392253.55655.42
555166-5516654.79256.65
654087-5408753.72055.61
120min151872-5187251.52052.841.2753.6855.001.23
253312-5331252.95055.11
353663-5366353.29955.49
453686-5368653.32255.48
553352-5335252.99055.15
653294-5329452.93255.12
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152749-5274952.39153.170.9254.8455.630.88
253581-5358153.21855.67
353849-5384953.48455.98
453814-5381453.44955.90
554038-5403853.67156.13
653164-5316452.80355.28
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%
111.211013141011641012981013711015111013320.13
211.201007481009271008380.13
单位质量响应值RSD%判断
9039.439003.390.29数据可信
供试品溶液-B2022B01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%
5min136982-3698236.81038.482.5136.8138.482.51
239147-3914738.96438.96
339136-3913638.95338.95
439284-3928439.10139.10
539413-3941339.22939.23
637985-3798537.80837.81
10min147306-4730647.08545.302.2147.2945.512.20
245506-4550645.29445.51
345669-4566945.45645.67
444371-4437144.16444.38
545409-4540945.19745.42
644811-4481144.60244.81
15min147628-4762847.40647.791.0547.8748.261.04
248706-4870648.47948.95
348101-4810147.87748.35
447729-4772947.50647.97
548470-4847048.24448.71
647439-4743947.21847.68
20min149404-4940449.17449.971.2649.9050.701.25
250817-5081750.58051.32
349769-4976949.53750.27
450594-5059450.35851.08
550865-5086550.62851.36
649775-4977549.54350.26
30min148630-4863048.40350.342.1149.4151.352.06
251233-5123350.99452.01
350167-5016749.93350.94
451237-5123750.99852.00
550743-5074350.50651.52
651472-5147251.23252.23
45min151625-5162551.38452.582.0552.6653.872.01
252258-5225852.01453.32
353703-5370353.45354.74
452108-5210851.86553.15
554495-5449554.24155.54
652783-5278352.53753.82
60min153410-5341053.16151.921.8354.7253.501.76
252981-5298152.73454.32
351249-5124951.01052.59
451048-5104850.81052.39
551823-5182351.58153.18
652464-5246452.21953.79
90min153344-5334453.09552.961.8854.9554.831.82
254428-5442854.17456.06
352077-5207751.83453.70
452373-5237352.12953.99
552708-5270852.46254.35
654316-5431654.06355.92
120min152210-5221051.96652.511.2154.1154.671.15
251834-5183451.59253.78
353405-5340553.15655.31
453263-5326353.01555.16
553166-5316652.91855.10
652657-5265752.41154.57
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151873-5187351.63153.091.9654.0755.551.88
252663-5266352.41754.89
354496-5449654.24256.69
453064-5306452.81755.26
554526-5452654.27256.74
653439-5343953.19055.64
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%
111.211014071016061012091009651012831012940.24
211.201020061017141018600.21
单位质量响应值RSD%判断
9036.049094.640.46数据可信
供试品溶液-B2022B01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%
5min136268-3626835.92437.082.5635.9237.082.56
237369-3736937.01537.01
338980-3898038.61038.61
436862-3686236.51336.51
538044-3804437.68337.68
637093-3709336.74136.74
10min142931-4293142.52442.461.8842.7242.661.87
243054-4305442.64642.85
341915-4191541.51841.73
442093-4209341.69441.90
544156-4415643.73743.95
643049-4304942.64142.84
15min144933-4493344.50744.700.7544.9445.140.76
244898-4489844.47244.91
344995-4499544.56845.01
445179-4517944.75145.19
545784-4578445.35045.80
644960-4496044.53444.97
20min145922-4592245.48745.461.4046.1746.161.39
245306-4530644.87645.57
345354-4535444.92445.62
445620-4562045.18745.87
547011-4701146.56547.27
646178-4617845.74046.43
30min146717-4671746.27446.611.0847.2147.551.07
246676-4667646.23347.17
346621-4662146.17947.12
447095-4709546.64847.58
547261-4726146.81347.78
647949-4794947.49448.44
45min146710-4671046.26747.382.6247.4648.582.55
247638-4763847.18648.38
350186-5018649.71050.91
448098-4809847.64248.84
547311-4731146.86248.09
647040-4704046.59447.80
60min148066-4806647.61047.371.5549.0648.841.48
248536-4853648.07649.53
348346-4834647.88849.36
448189-4818947.73249.19
546709-4670946.26647.75
647107-4710746.66048.13
90min146716-4671646.27347.071.8647.9948.801.79
248126-4812647.67049.39
346811-4681146.36748.11
449011-4901148.54650.27
547180-4718046.73348.47
647296-4729646.84848.57
120min147151-4715146.70447.401.1848.6849.391.14
248230-4823047.77349.76
348618-4861848.15750.16
448092-4809247.63649.63
547674-4767447.22249.22
647343-4734346.89448.88
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146957-4695746.51247.282.0648.7449.531.99
246882-4688246.43848.69
348114-4811447.65849.92
449517-4951749.04851.31
547342-4734246.89349.16
647573-4757347.12249.37
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