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%
111.21100005100168998829999399774999640.15
211.279952899747996380.16
单位质量响应值RSD%判断
8917.408840.990.61数据可信
供试品溶液-25032501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%
5min133516-3351633.89434.371.4433.8934.371.44
233787-3378734.16934.17
333491-3349133.86933.87
434372-3437234.76034.76
534070-3407034.45534.45
634708-3470835.10035.10
10min142540-4254043.02042.301.5243.2142.491.52
241140-4114041.60541.79
341550-4155042.01942.21
442570-4257043.05143.24
541953-4195342.42742.62
641203-4120341.66841.86
15min145968-4596846.48746.141.4246.9146.571.40
246713-4671347.24147.66
345135-4513545.64546.07
445703-4570346.21946.65
545220-4522045.73146.16
645020-4502045.52845.95
20min147921-4792148.46247.861.8749.1548.541.85
247726-4772648.26548.95
345685-4568546.20146.88
447548-4754848.08548.77
546994-4699447.52548.21
648054-4805448.59749.28
30min147142-4714247.67448.572.0248.6349.521.97
246674-4667447.20148.15
349080-4908049.63450.57
447872-4787248.41349.37
548688-4868849.23850.18
648718-4871849.26850.22
45min149906-4990650.47050.331.5051.6951.551.47
248392-4839248.93850.15
349814-4981450.37751.58
450417-5041750.98652.21
549664-4966450.22551.44
650415-5041550.98452.21
60min149298-4929849.85549.741.9551.3551.231.90
247704-4770448.24349.73
348742-4874249.29250.78
449175-4917549.73051.24
550613-5061351.18552.68
649558-4955850.11851.62
90min149055-4905549.60950.831.7351.3952.611.69
249706-4970650.26752.02
350329-5032950.89752.66
451529-5152952.11153.90
550874-5087451.44953.23
650103-5010350.66952.45
120min151409-5140951.99052.141.7254.0454.201.63
252378-5237852.96955.00
352804-5280453.40055.44
450848-5084851.42253.50
551414-5141451.99554.06
650494-5049451.06453.13
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151876-5187652.46250.962.3254.8053.312.22
250134-5013450.70053.03
348955-4895549.50851.85
450978-5097851.55453.91
551220-5122051.79854.16
649201-4920149.75752.11
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%
111.219991299568997419948599617996650.17
211.271003931009321006620.38
单位质量响应值RSD%判断
8890.728931.850.33数据可信
供试品溶液-25032501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%
5min136883-3688337.16537.502.4837.1637.502.48
236110-3611036.38636.39
337986-3798638.27638.28
438629-3862938.92438.92
536704-3670436.98436.98
636974-3697437.25637.26
10min143246-4324643.57643.412.8243.7843.622.81
243911-4391144.24644.45
343342-4334243.67343.89
443169-4316943.49943.71
544078-4407844.41544.62
640725-4072541.03641.24
15min147025-4702547.38446.311.8947.8346.761.88
244804-4480445.14645.59
345883-4588346.23346.69
446387-4638746.74147.20
546567-4656746.92347.37
645111-4511145.45645.89
20min148258-4825848.62748.421.5349.3449.121.54
247332-4733247.69348.39
348705-4870549.07749.79
448737-4873749.10949.83
548306-4830648.67549.39
646968-4696847.32748.01
30min147809-4780948.17448.571.0149.1649.551.00
247464-4746447.82748.79
348180-4818048.54849.53
448662-4866249.03450.02
548456-4845648.82649.81
648658-4865849.03049.98
45min150076-5007650.45850.131.8951.7151.371.85
249090-4909049.46550.69
350709-5070951.09652.35
450714-5071451.10152.36
548354-4835448.72349.98
649531-4953149.90951.13
60min149926-4992650.30750.481.9251.8452.001.85
249983-4998350.36551.87
348328-4832848.69750.24
450916-5091651.30552.85
550739-5073951.12752.65
650696-5069651.08352.58
90min147374-4737447.73649.102.8649.5550.912.77
249848-4984850.22952.01
349191-4919149.56751.38
449790-4979050.17052.00
549583-4958349.96251.77
646609-4660946.96548.75
120min150496-5049650.88250.512.3552.9652.592.29
250106-5010650.48952.55
351233-5123351.62453.71
451341-5134151.73353.84
549327-4932749.70451.79
648267-4826748.63650.68
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152935-5293553.33951.562.1955.7053.922.09
251196-5119651.58753.93
349474-4947449.85252.22
450843-5084351.23153.63
551531-5153151.92554.29
651038-5103851.42853.74
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%
111.211004031001169984599934999661000530.22
211.271000751004181002460.25
单位质量响应值RSD%判断
8925.338894.940.25数据可信
供试品溶液-25032501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%
5min136103-3610336.38337.491.9736.3837.501.97
236780-3678037.06637.07
337316-3731637.60637.61
437052-3705237.34037.34
538070-3807038.36638.37
637910-3791038.20438.20
10min140819-4081941.13641.611.5441.3441.811.53
241625-4162541.94842.15
340755-4075541.07141.28
442367-4236742.69642.90
541336-4133641.65741.87
640813-4081341.13041.34
15min142514-4251442.84444.262.0943.2744.702.08
244796-4479645.14445.58
343140-4314043.47543.91
444776-4477645.12445.57
544131-4413144.47444.92
644139-4413944.48244.92
20min143227-4322743.56344.170.8244.2344.860.83
244285-4428544.62945.32
343692-4369244.03144.71
443948-4394844.28944.98
544030-4403044.37245.06
643820-4382044.16044.85
30min144400-4440044.74544.820.4845.6645.750.48
244696-4469645.04345.98
344163-4416344.50645.43
444347-4434744.69145.63
544520-4452044.86645.80
644708-4470845.05545.99
45min145239-4523945.59045.232.5246.7546.412.46
246332-4633246.69247.88
343956-4395644.29745.47
445917-4591746.27447.46
544380-4438044.72545.91
643475-4347543.81345.00
60min146198-4619846.55745.772.4247.9747.202.35
246217-4621746.57648.02
344781-4478145.12946.55
446594-4659446.95648.40
544944-4494445.29346.73
643762-4376244.10245.53
90min146128-4612846.48646.491.4448.1648.181.40
246145-4614546.50348.21
346819-4681947.18348.85
446825-4682547.18948.90
545796-4579646.15247.84
645070-4507045.42047.09
120min145342-4534245.69446.422.5447.6248.362.47
247658-4765848.02849.99
346418-4641846.77848.71
446575-4657546.93748.91
546154-4615446.51248.46
644229-4422944.57246.50
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147862-4786248.23447.943.3650.4250.143.21
247127-4712747.49349.72
348999-4899949.37951.57
448550-4855048.92751.16
544577-4457744.92347.13
648280-4828048.65550.83
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