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%
111.209923610006099915100226100175999220.41
211.169988499758998210.09
单位质量响应值RSD%判断
8921.618944.530.19数据可信
供试品溶液-2025062721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%
5min133091-3309133.26234.493.4933.2634.493.49
232744-3274432.91432.91
334137-3413734.31434.31
435401-3540135.58435.58
535578-3557835.76235.76
634944-3494435.12535.12
10min139476-3947639.68039.141.4439.8739.341.42
238833-3883339.03439.22
339777-3977739.98340.17
438380-3838038.57938.78
538564-3856438.76438.96
638620-3862038.82039.02
15min140201-4020140.40941.391.5540.8141.801.54
241891-4189142.10842.51
341731-4173141.94742.36
441455-4145541.67042.08
540997-4099741.20941.62
640803-4080341.01441.43
20min141112-4111241.32542.331.2841.9542.961.27
242537-4253742.75743.39
342288-4228842.50743.15
442576-4257642.79643.44
542019-4201942.23742.88
642114-4211442.33242.97
30min142734-4273442.95543.501.8443.8144.381.81
241999-4199942.21643.09
344240-4424044.46945.35
443450-4345043.67544.56
543656-4365643.88244.76
643605-4360543.83144.70
45min143810-4381044.03744.061.2945.1345.171.27
243260-4326043.48444.59
343816-4381644.04345.17
444903-4490345.13546.26
543639-4363943.86544.99
643545-4354543.77044.89
60min144046-4404644.27444.221.1045.6245.581.05
244759-4475944.99146.34
344055-4405544.28345.66
443840-4384044.06745.44
543262-4326243.48644.85
643963-4396344.19145.55
90min144422-4442244.65245.110.9146.2446.710.90
244833-4483345.06546.66
345566-4556645.80247.42
444926-4492645.15946.78
544981-4498145.21446.82
644509-4450944.73946.35
120min143305-4330543.52944.641.4645.3746.491.43
244005-4400544.23346.08
344884-4488445.11646.99
444650-4465044.88146.75
544546-4454644.77746.63
645048-4504845.28147.14
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144682-4468244.91345.291.1546.9947.401.12
244910-4491045.14247.24
345124-4512445.35847.48
445571-4557145.80747.93
544352-4435244.58246.69
645696-4569645.93348.04
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%
111.2010007999463990999947099339994900.37
211.161008301005791007040.18
单位质量响应值RSD%判断
8883.049023.661.12数据可信
供试品溶液-2025062821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%
5min133534-3353433.63334.012.2333.6334.012.24
233890-3389033.99033.99
332937-3293733.03533.03
433772-3377233.87233.87
534123-3412334.22434.22
635215-3521535.31935.32
10min137783-3778337.89538.611.8238.0838.801.82
239281-3928139.39739.59
337661-3766137.77337.96
438357-3835738.47138.66
538668-3866838.78238.97
639249-3924939.36539.56
15min139686-3968639.80340.841.9140.2041.241.90
241205-4120541.32741.73
340711-4071140.83241.22
441380-4138041.50341.90
539879-3987939.99740.40
641470-4147041.59342.01
20min143013-4301343.14042.471.2543.7643.101.23
242363-4236342.48843.13
341516-4151641.63942.26
442453-4245342.57943.21
542713-4271342.83943.47
642015-4201542.13942.79
30min142186-4218642.31142.761.1943.1743.631.17
243096-4309643.22444.10
343206-4320643.33444.19
442961-4296143.08843.96
542222-4222242.34743.21
642129-4212942.25443.13
45min144527-4452744.65944.841.4445.7545.941.42
245298-4529845.43246.55
344431-4443144.56345.65
444669-4466944.80145.91
543758-4375843.88844.99
645537-4553745.67246.79
60min142980-4298043.10743.941.5544.4545.291.52
243688-4368843.81745.18
344061-4406144.19145.53
444553-4455344.68546.04
543087-4308743.21544.56
644489-4448944.62145.99
90min144465-4446544.59744.993.2646.1846.583.17
244330-4433044.46146.07
343899-4389944.02945.61
444316-4431644.44746.05
544312-4431244.44346.03
647815-4781547.95749.57
120min145183-4518345.31745.151.1647.1547.001.12
244845-4484544.97846.83
345204-4520445.33847.17
445685-4568545.82047.67
544122-4412244.25346.08
645071-4507145.20447.09
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145098-4509845.23245.101.3547.3147.201.31
244436-4443644.56846.67
344538-4453844.67046.75
444633-4463344.76546.87
545037-4503745.17047.25
646074-4607446.21048.34
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%
111.201004551001521005921000221007461003930.31
211.169989698708993020.85
单位质量响应值RSD%判断
8963.668898.030.52数据可信
供试品溶液-2025062821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%
5min131125-3112531.29433.603.6431.2933.603.64
233270-3327033.45133.45
333938-3393834.12334.12
434555-3455534.74334.74
533507-3350733.68933.69
634140-3414034.32634.33
10min138219-3821938.42738.981.5438.6039.161.55
238576-3857638.78638.97
339611-3961139.82640.02
438199-3819938.40738.60
538607-3860738.81739.00
639385-3938539.59939.79
15min139399-3939939.61340.751.5140.0041.151.51
240642-4064240.86341.26
341068-4106841.29141.70
440782-4078241.00441.41
540936-4093641.15941.56
640332-4033240.55140.96
20min141843-4184342.07141.841.2342.6842.481.22
240655-4065540.87641.50
341500-4150041.72642.37
441901-4190142.12942.76
541719-4171941.94642.58
642091-4209142.32042.96
30min142828-4282843.06143.060.7443.9043.930.73
242393-4239342.62443.48
343357-4335743.59344.46
442739-4273942.97143.84
542743-4274342.97543.84
642931-4293143.16544.04
45min144440-4444044.68244.431.4945.7645.531.45
244345-4434544.58645.68
344524-4452444.76645.88
445029-4502945.27446.38
543274-4327443.50944.61
643539-4353943.77644.89
60min143079-4307943.31344.361.8244.6445.711.79
243943-4394344.18245.52
344726-4472644.96946.33
444492-4449244.73446.09
543373-4337343.60944.95
645129-4512945.37446.73
90min145143-4514345.38944.681.2346.9646.281.17
244805-4480545.04946.63
344602-4460244.84546.46
443613-4361343.85045.46
544068-4406844.30845.89
644426-4442644.66846.27
120min143936-4393644.17543.923.0446.0045.772.91
242919-4291943.15244.99
341662-4166241.88943.75
443644-4364443.88145.73
544375-4437544.61646.45
645575-4557545.82347.68
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144419-4441944.66145.883.1646.7347.963.04
246134-4613446.38548.46
343678-4367843.91646.01
447585-4758547.84449.94
545352-4535245.59947.68
646612-4661246.86648.97
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