玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.339967399720994749956599754996370.12
211.349920099349992740.11
单位质量响应值RSD%判断
8794.098754.320.33数据可信
供试品溶液-2025051521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%
5min127894-2789428.54627.147.7928.5527.147.79
224610-2461025.18525.19
323871-2387124.42924.43
425691-2569126.29226.29
528655-2865529.32529.32
628397-2839729.06129.06
10min136996-3699637.86137.412.5538.1837.712.58
236823-3682337.68437.96
334709-3470935.52135.79
436539-3653937.39337.69
537057-3705737.92338.25
637181-3718138.05038.37
15min140080-4008041.01741.251.4541.7541.971.48
240490-4049041.43742.14
339291-3929140.21040.88
440584-4058441.53342.24
541013-4101341.97242.72
640401-4040141.34642.09
20min142171-4217143.15743.641.4544.3544.821.45
243102-4310244.11045.27
341918-4191842.89844.01
442699-4269943.69744.87
542386-4238643.37744.59
643573-4357344.59245.80
30min143265-4326544.27745.061.4645.9546.721.41
244690-4469045.73547.38
343937-4393744.96446.55
443849-4384944.87446.53
543537-4353744.55546.25
644890-4489045.94047.64
45min145486-4548646.54946.360.7148.7148.510.65
245235-4523546.29348.45
345502-4550246.56648.65
445426-4542646.48848.64
544679-4467945.72447.91
645451-4545146.51448.72
60min146041-4604147.11746.751.5449.8049.431.44
246100-4610047.17849.85
345237-4523746.29548.90
446236-4623647.31749.99
546051-4605147.12849.83
644452-4445245.49148.22
90min145750-4575046.82047.381.7550.0350.581.63
245602-4560246.66849.86
346771-4677147.86550.99
446888-4688847.98451.18
545416-4541646.47849.70
647357-4735748.46451.70
120min146898-4689847.99448.260.7951.7251.980.77
247050-4705048.15051.86
346757-4675747.85051.50
447777-4777748.89452.62
547390-4739048.49852.24
647052-4705248.15251.92
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146999-4699948.09848.660.9252.3652.920.81
247852-4785248.97153.22
347897-4789749.01753.20
447992-4799249.11453.39
547080-4708048.18152.46
647478-4747848.58852.89
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.331001701003431003421001271000151001990.15
211.34998321001821000070.25
单位质量响应值RSD%判断
8843.698818.960.20数据可信
供试品溶液-2025051621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%
5min127338-2733827.79626.864.4227.8026.864.43
224783-2478325.19825.20
325438-2543825.86425.86
427609-2760928.07228.07
527290-2729027.74727.75
626027-2602726.46326.46
10min137769-3776938.40237.532.1538.7137.822.16
236609-3660937.22237.50
335736-3573636.33536.62
437640-3764038.27138.58
537284-3728437.90938.22
636404-3640437.01437.31
15min141106-4110641.79541.112.0242.5341.831.98
240158-4015840.83141.52
340990-4099041.67742.37
439174-3917439.83040.57
541241-4124141.93242.66
639932-3993240.60141.31
20min143128-4312843.85143.590.8645.0544.760.84
242954-4295443.67444.82
342515-4251543.22744.38
443172-4317243.89545.08
542316-4231643.02544.22
643152-4315243.87545.03
30min143293-4329344.01844.931.4445.7146.591.38
243529-4352944.25845.89
344701-4470145.45047.08
444273-4427345.01546.68
544806-4480645.55747.23
644548-4454845.29546.94
45min145319-4531946.07846.330.4548.2548.480.41
245635-4563546.40048.52
345553-4555346.31648.46
445433-4543346.19448.36
545548-4554846.31148.49
645910-4591046.67948.83
60min145135-4513545.89147.072.1048.5849.741.99
245741-4574146.50849.15
346575-4657547.35550.01
445549-4554946.31248.99
547312-4731248.10550.80
647473-4747348.26950.93
90min149305-4930550.13148.471.8453.3351.661.75
247108-4710847.89751.05
347229-4722948.02051.20
447646-4764648.44451.64
547856-4785648.65851.89
646880-4688047.66650.87
120min145766-4576646.53347.611.2250.2951.351.12
247121-4712147.91151.60
346710-4671047.49351.21
446839-4683947.62451.36
547191-4719147.98251.75
647348-4734848.14151.87
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147192-4719247.98348.330.6252.2552.600.54
247974-4797448.77853.00
347498-4749848.29452.54
447782-4778248.58352.85
547428-4742848.22352.53
647341-4734148.13452.40
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.331014791017691014441015261016041015640.13
211.341010341009111009720.09
单位质量响应值RSD%判断
8964.178904.060.48数据可信
供试品溶液-2025051622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%
5min123929-2392924.05025.166.1824.0525.166.18
226112-2611226.24426.24
324555-2455524.67924.68
422923-2292323.03923.04
525448-2544825.57725.58
627206-2720627.34427.34
10min136240-3624036.42436.092.2736.6936.372.30
236402-3640236.58736.88
335544-3554435.72436.00
434473-3447334.64834.90
536017-3601736.20036.48
636782-3678236.96837.27
15min139467-3946739.66740.002.4940.3440.682.50
239781-3978139.98340.68
339936-3993640.13840.81
438095-3809538.28838.93
540710-4071040.91641.60
640814-4081441.02141.74
20min142287-4228742.50142.340.8643.6143.470.90
242586-4258642.80243.94
341885-4188542.09743.21
441605-4160541.81642.88
542035-4203542.24843.39
642384-4238442.59943.77
30min143504-4350443.72544.541.0445.3146.141.02
244275-4427544.49946.12
344126-4412644.35045.93
444718-4471844.94546.48
544629-4462944.85546.47
644632-4463244.85846.50
45min144879-4487945.10746.082.7447.1848.172.62
245004-4500445.23247.34
348136-4813648.38050.46
445765-4576545.99748.03
544970-4497045.19847.31
646318-4631846.55348.69
60min145967-4596746.20046.740.7848.7749.340.74
246587-4658746.82349.44
346955-4695547.19349.81
446720-4672046.95749.50
546590-4659046.82649.44
646198-4619846.43249.09
90min145225-4522545.45446.731.8948.5449.861.78
246623-4662346.85949.99
345720-4572045.95249.09
447583-4758347.82450.89
546744-4674446.98150.11
647095-4709547.33450.51
120min148392-4839248.63747.971.0052.2351.610.89
247428-4742847.66851.32
347081-4708147.32050.97
448070-4807048.31451.91
547540-4754047.78151.43
647881-4788148.12451.82
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149536-4953649.78748.221.9353.9252.391.72
247189-4718947.42851.61
348440-4844048.68652.86
447886-4788648.12952.26
547777-4777748.01952.20
647011-4701147.24951.49
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