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%
111.219953499534995769948199541995330.04
211.209966199750997060.07
单位质量响应值RSD%判断
8878.958902.320.19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%
5min139780-3978040.17739.980.8440.1839.980.84
239222-3922239.61339.61
339988-3998840.38740.39
439208-3920839.59939.60
539820-3982040.21740.22
639467-3946739.86139.86
10min145413-4541345.86645.582.8146.0945.802.80
246115-4611546.57546.80
346944-4694447.41247.64
444486-4448644.93045.15
543546-4354643.98044.20
644277-4427744.71944.94
15min146921-4692147.38947.902.2347.8748.382.22
247266-4726647.73748.22
349477-4947749.97150.46
446434-4643446.89747.37
547255-4725547.72648.19
647209-4720947.68048.15
20min149020-4902049.50949.721.4350.2550.461.43
249326-4932649.81850.56
350544-5054451.04851.81
449172-4917249.66250.39
548551-4855149.03549.77
648755-4875549.24149.98
30min148981-4898149.47050.512.2450.4951.522.22
250838-5083851.34552.37
351788-5178852.30553.35
449001-4900149.49050.50
549993-4999350.49251.50
649439-4943949.93250.94
45min151110-5111051.62051.732.2352.9153.032.21
250806-5080651.31352.62
353486-5348654.02055.36
450947-5094751.45552.74
550468-5046850.97152.26
650478-5047850.98252.27
60min149706-4970650.20252.413.5751.7854.003.51
252405-5240552.92854.52
355210-5521055.76157.40
451098-5109851.60853.17
551731-5173152.24753.82
651228-5122851.73953.31
90min153050-5305053.57953.312.8455.4455.192.80
252376-5237652.89854.78
355639-5563956.19458.14
452284-5228452.80654.66
551409-5140951.92253.78
651970-5197052.48854.34
120min150685-5068551.19153.053.1353.3555.223.06
251342-5134251.85454.03
355420-5542055.97358.23
452665-5266553.19055.34
552164-5216452.68454.83
652863-5286353.39055.54
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151883-5188352.40153.926.2254.8456.396.04
252690-5269053.21655.68
360099-6009960.69863.27
452067-5206752.58655.03
551333-5133351.84554.29
652246-5224652.76755.21
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%
111.219954899594998019992499764997260.16
211.209969499822997580.10
单位质量响应值RSD%判断
8896.168906.960.09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%
5min135647-3564735.95837.232.2535.9637.242.25
236944-3694437.26737.27
337897-3789738.22838.23
437114-3711437.43837.44
537569-3756937.89737.90
636299-3629936.61636.62
10min143340-4334043.71844.421.3043.9244.621.30
243798-4379844.18044.39
344931-4493145.32345.54
443916-4391644.30044.51
544464-4446444.85245.06
643746-4374644.12844.33
15min145324-4532445.72047.381.8846.1647.841.87
246956-4695647.36647.82
347172-4717247.58448.05
446950-4695047.36047.81
547738-4773848.15548.61
647703-4770348.12048.57
20min147866-4786648.28449.551.7848.9850.271.77
248432-4843248.85549.57
350194-5019450.63251.36
449586-4958650.01950.74
549709-4970950.14350.87
648965-4896549.39350.11
30min149442-4944249.87450.420.9650.8451.420.96
250042-5004250.47951.47
350716-5071651.15952.17
449509-4950949.94150.94
550246-5024650.68551.69
649963-4996350.39951.39
45min149905-4990550.34151.301.7251.5852.571.70
250502-5050250.94352.21
351016-5101651.46252.76
450316-5031650.75552.03
552412-5241252.87054.16
650982-5098251.42752.70
60min150979-5097951.42451.600.6352.9553.160.64
251031-5103151.47753.03
351724-5172452.17653.76
451101-5110151.54753.10
551262-5126251.71053.29
650802-5080251.24652.80
90min151556-5155652.00652.321.1953.8154.161.16
252973-5297353.43655.27
352090-5209052.54554.41
451292-5129251.74053.58
551890-5189052.34354.21
651421-5142151.87053.71
120min150989-5098951.43452.302.1853.5354.432.12
251638-5163852.08954.22
354090-5409054.56256.72
451636-5163652.08754.22
551371-5137151.82053.98
651332-5133251.78053.91
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151039-5103951.48552.391.1053.8754.811.09
251928-5192852.38154.80
352276-5227652.73355.20
452080-5208052.53554.95
552683-5268353.14355.59
651601-5160152.05254.47
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%
111.211005031005951004681005971004711005270.07
211.201002251003411002830.09
单位质量响应值RSD%判断
8967.628953.840.11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%
5min136218-3621836.29337.743.8036.2937.743.80
236844-3684436.92036.92
340207-4020740.29040.29
437817-3781737.89537.90
536795-3679536.87136.87
638119-3811938.19838.20
10min141944-4194442.03141.690.8542.2341.900.85
241727-4172741.81442.02
341463-4146341.54941.77
441059-4105941.14441.35
541429-4142941.51541.72
641983-4198342.07042.28
15min141773-4177341.86042.941.5642.2943.381.56
242633-4263342.72143.16
343395-4339543.48543.94
443610-4361043.70044.14
543131-4313143.22043.66
642579-4257942.66743.11
20min142203-4220342.29044.052.0142.9644.731.99
244294-4429444.38645.06
344131-4413144.22244.92
444089-4408944.18044.86
544571-4457144.66345.34
644470-4447044.56245.25
30min145205-4520545.29944.554.3946.2045.474.29
246028-4602846.12347.04
341111-4111141.19642.14
445963-4596346.05846.99
543119-4311943.20844.13
645319-4531945.41346.34
45min145106-4510645.20045.521.1346.3546.691.13
246242-4624246.33847.52
345304-4530445.39846.57
445678-4567845.77346.96
544745-4474544.83846.00
645465-4546545.55946.74
60min146153-4615346.24945.941.5347.6547.361.47
246204-4620446.30047.73
346135-4613546.23147.65
446240-4624046.33647.77
545908-4590846.00347.42
644443-4444344.53545.97
90min147087-4708747.18546.790.6148.8548.480.57
246610-4661046.70748.40
346574-4657446.67148.35
446655-4665546.75248.45
546953-4695347.05048.72
646301-4630146.39748.08
120min147951-4795148.05047.411.3049.9749.351.24
247874-4787447.97349.92
347438-4743847.53649.48
446945-4694547.04249.00
547345-4734547.44349.37
646314-4631446.41048.35
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147324-4732447.42247.150.5349.6149.360.50
246791-4679146.88849.11
346955-4695547.05249.26
447355-4735547.45349.67
547115-4711547.21349.41
646804-4680446.90149.10
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