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)0
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%
111.059919098795985679847398732987510.29
211.119874898765987560.02
单位质量响应值RSD%判断
8936.748888.930.38数据可信
中间条件6月-供试品溶液-2025051221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%
5min118432-1843218.57023.6524.3918.5723.6524.38
220781-2078120.93620.94
316077-1607716.19716.20
428490-2849028.70328.70
528247-2824728.45828.46
628809-2880929.02429.02
10min131455-3145531.69035.0510.1431.9035.3210.25
232843-3284333.08833.32
330656-3065630.88531.06
437841-3784138.12338.44
538452-3845238.73939.06
637522-3752237.80238.12
15min138530-3853038.81840.374.4439.3841.024.62
238837-3883739.12739.73
338023-3802338.30738.83
441609-4160941.92042.66
541599-4159941.91042.66
641809-4180942.12142.86
20min142068-4206842.38243.593.7243.3744.693.90
241797-4179742.10943.14
341623-4162341.93442.88
445188-4518845.52546.73
544670-4467045.00346.22
644256-4425644.58645.80
30min144781-4478145.11546.441.9246.5848.032.11
245427-4542745.76647.27
345917-4591746.26047.67
447098-4709847.45049.16
546666-4666647.01448.73
646697-4669747.04648.75
45min149472-4947249.84149.540.8651.8051.650.87
248433-4843348.79550.81
349481-4948149.85051.78
449537-4953749.90752.15
549098-4909849.46451.70
649046-4904649.41251.64
60min149110-4911049.47750.421.0951.9953.071.10
250790-5079051.16953.72
350173-5017350.54853.03
450202-5020250.57753.37
550063-5006350.43753.22
649931-4993150.30453.08
90min150491-5049150.86851.681.8653.9354.891.77
252773-5277353.16756.29
351065-5106551.44654.49
451856-5185652.24355.60
550150-5015050.52453.87
651455-5145551.83955.18
120min152321-5232152.71252.451.1456.3456.241.08
252669-5266953.06256.77
351573-5157351.95855.57
452752-5275253.14657.08
551398-5139851.78255.69
651668-5166852.05455.97
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152151-5215152.54052.820.6256.7657.190.66
252408-5240852.79957.10
352657-5265753.05057.24
452945-5294553.34057.87
552267-5226752.65757.14
652125-5212552.51457.01
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)0
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%
111.059916299409992659951299905994510.29
211.119969899778997380.06
单位质量响应值RSD%判断
9000.098977.320.18数据可信
中间条件6月-供试品溶液-2025051221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%
5min127948-2794827.91923.5323.2227.9223.5323.22
218831-1883118.81118.81
316212-1621216.19516.20
428757-2875728.72728.73
521334-2133421.31221.31
628245-2824528.21528.22
10min138429-3842938.38934.939.7438.7035.199.83
231981-3198131.94832.16
330723-3072330.69130.87
437715-3771537.67637.99
533148-3314833.11333.35
637819-3781937.77938.09
15min141368-4136841.32540.034.1242.0640.684.30
238685-3868538.64539.21
338022-3802237.98238.50
441568-4156841.52542.26
539084-3908439.04339.65
641677-4167741.63342.37
20min144843-4484344.79643.353.6645.9944.443.83
242233-4223342.18943.18
341710-4171041.66642.61
444852-4485244.80546.00
541920-4192041.87642.91
644811-4481144.76445.96
30min146456-4645646.40746.012.0148.1047.592.18
244793-4479344.74646.21
345809-4580945.76147.17
446813-4681346.76448.46
545303-4530345.25646.76
647199-4719947.15048.84
45min149575-4957549.52349.060.8051.7351.150.86
249002-4900248.95150.91
349434-4943449.38251.30
448851-4885148.80051.02
548534-4853448.48350.49
649264-4926449.21351.43
60min150215-5021550.16349.851.4952.9252.481.51
248476-4847648.42550.93
350172-5017250.12052.58
449798-4979849.74652.50
550591-5059150.53853.08
650136-5013650.08452.85
90min150361-5036150.30851.411.7153.6354.601.66
250742-5074250.68953.73
351127-5112751.07454.09
451660-5166051.60654.92
552546-5254652.49155.60
652346-5234652.29155.61
120min152563-5256352.50851.990.9356.3855.750.83
251748-5174851.69455.30
352359-5235952.30455.89
451855-5185551.80155.69
552437-5243752.38256.07
651320-5132051.26655.17
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152089-5208952.03552.410.5856.4956.740.48
252330-5233052.27556.45
352679-5267952.62456.79
452197-5219752.14256.60
552855-5285552.80057.07
652615-5261552.56057.03
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)0
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%
111.059829998457985439817898583984120.18
211.119938699302993440.06
单位质量响应值RSD%判断
8906.068941.850.29数据可信
中间条件6月-供试品溶液-2025051421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%
5min116055-1605516.15521.3121.1716.1521.3121.18
222805-2280522.94722.95
315378-1537815.47315.47
422002-2200222.13922.14
524598-2459824.75124.75
626237-2623726.40026.40
10min131488-3148831.68333.488.2431.8633.728.33
233864-3386434.07434.33
329467-2946729.65029.82
432365-3236532.56632.81
535421-3542135.64135.92
637028-3702837.25837.55
15min138586-3858638.82539.684.4739.3640.304.59
239646-3964639.89240.53
336491-3649136.71737.22
439562-3956239.80840.42
541270-4127041.52642.20
641081-4108141.33642.04
20min142567-4256742.83143.253.1243.7944.303.25
243453-4345343.72344.80
340857-4085741.11142.02
442833-4283343.09944.15
543219-4321943.48744.62
644971-4497145.25046.42
30min147344-4734447.63847.351.5649.0848.881.62
247871-4787148.16849.73
345870-4587046.15547.52
447183-4718347.47649.00
547534-4753447.82949.44
646525-4652546.81448.48
45min148028-4802848.32649.241.6250.2951.301.63
250075-5007550.38652.48
348754-4875449.05750.94
449111-4911149.41651.47
549504-4950449.81151.96
648144-4814448.44350.63
60min150469-5046950.78250.671.2853.2953.271.18
251018-5101851.33553.99
350218-5021850.53052.95
450927-5092751.24353.85
550260-5026050.57253.27
649237-4923749.54352.27
90min148996-4899649.30050.351.3852.3753.511.37
250512-5051250.82554.05
350463-5046350.77653.76
449715-4971550.02453.20
549677-4967749.98553.25
650846-5084651.16254.44
120min151506-5150651.82651.980.8555.4455.710.68
251295-5129551.61355.41
352492-5249252.81856.37
451439-5143951.75855.49
551477-5147751.79655.61
651764-5176452.08555.93
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151120-5112051.43751.520.9255.6355.820.70
251079-5107951.39655.76
352145-5214552.46956.61
450997-5099751.31355.62
550895-5089551.21155.60
650991-5099151.30755.73
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)0
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%
111.059894098925987929883498491987960.19
211.119836698453984100.07
单位质量响应值RSD%判断
8940.818857.790.66数据可信
中间条件6月-供试品溶液-2025051321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%
5min118738-1873818.90722.2113.6818.9122.2113.68
220568-2056820.75320.75
319769-1976919.94719.95
423854-2385424.06924.07
526916-2691627.15927.16
622210-2221022.41022.41
10min132258-3225832.54934.055.0332.7634.295.09
233414-3341433.71533.95
331747-3174732.03332.25
435433-3543335.75236.02
536024-3602436.34936.65
633577-3357733.88034.13
15min137900-3790038.24239.243.1438.8139.873.22
238083-3808338.42639.03
337888-3788838.22938.81
439827-3982740.18640.85
540864-4086441.23241.94
638782-3878239.13139.76
20min140897-4089741.26642.411.8642.2643.471.95
241897-4189742.27543.31
341760-4176042.13643.14
443049-4304943.43744.55
542793-4279343.17944.34
641803-4180342.18043.24
30min144216-4421644.61445.521.3046.0747.061.39
244912-4491245.31746.82
345191-4519145.59847.07
445125-4512545.53247.13
546033-4603346.44848.09
645212-4521245.61947.15
45min148558-4855848.99648.911.2350.9550.951.11
248559-4855948.99751.00
349518-4951849.96451.94
448092-4809248.52550.63
548351-4835148.78750.95
647770-4777048.20050.24
60min148827-4882749.26749.450.2851.7652.030.33
249186-4918649.62952.18
348985-4898549.42651.96
448895-4889549.33651.97
549060-4906049.50252.20
649108-4910849.55152.12
90min148943-4894349.38450.371.0452.4353.501.04
249980-4998050.43053.53
350439-5043950.89453.98
449886-4988650.33653.52
550145-5014550.59753.85
650140-5014050.59253.71
120min151649-5164952.11451.630.7155.7155.320.57
251152-5115251.61355.27
351547-5154752.01255.66
450821-5082151.27955.03
550999-5099951.45955.27
650821-5082151.27954.96
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151711-5171152.17751.761.0356.3556.030.92
250634-5063451.09055.33
351122-5112251.58355.81
451843-5184352.31056.63
550782-5078251.24055.63
651713-5171352.17956.43
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)0
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%
111.059842298435985249863598479984990.09
211.119794398051979970.08
单位质量响应值RSD%判断
8913.948820.610.75数据可信
中间条件6月-供试品溶液-2025051321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%
5min122391-2239122.67523.508.3722.6723.508.37
223730-2373024.03024.03
320676-2067620.93820.94
423603-2360323.90223.90
526464-2646426.79926.80
622343-2234322.62622.63
10min133349-3334933.77135.093.5334.0235.353.51
233708-3370834.13534.40
336103-3610336.56036.79
435402-3540235.85036.12
535732-3573236.18436.48
633634-3363434.06034.31
15min137749-3774938.22739.313.1538.8539.963.16
237939-3793938.41939.07
337960-3796038.44139.08
439962-3996240.46841.13
540675-4067541.19041.89
638598-3859839.08739.72
20min140757-4075741.27342.632.0242.3243.722.05
242155-4215542.68943.76
341703-4170342.23143.30
443255-4325543.80344.92
542649-4264943.18944.35
642056-4205642.58843.65
30min144136-4413644.69545.721.4746.2147.281.51
244827-4482745.39546.94
345179-4517945.75147.29
445406-4540645.98147.58
546149-4614946.73348.37
645179-4517945.75147.29
45min148530-4853049.14448.991.4051.1551.061.33
248307-4830748.91950.97
349534-4953450.16152.20
448040-4804048.64850.76
548392-4839249.00551.16
647485-4748548.08650.13
60min148712-4871249.32949.480.4251.8852.090.46
249044-4904449.66552.26
348583-4858349.19851.80
449128-4912849.75052.40
548892-4889249.51152.21
648804-4880449.42252.00
90min149183-4918349.80650.550.9752.9153.710.91
250357-5035750.99554.14
350170-5017050.80553.95
449737-4973750.36753.57
549633-4963350.26153.51
650422-5042251.06054.19
120min151526-5152652.17851.740.7455.8355.460.70
250719-5071951.36155.08
351119-5111951.76655.48
450738-5073851.38055.14
551559-5155952.21256.02
650898-5089851.54255.24
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151480-5148052.13251.970.9756.3756.260.91
252085-5208552.74457.03
350799-5079951.44255.73
451357-5135752.00756.34
551433-5143352.08456.47
650742-5074251.38455.65
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)0
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%
111.059853998478985219833198360984460.10
211.119819198180981860.01
单位质量响应值RSD%判断
8909.148837.620.57数据可信
中间条件6月-供试品溶液-2025051421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%
5min121994-2199422.25721.3420.7722.2621.3420.77
215297-1529715.48015.48
325814-2581426.12326.12
416172-1617216.36516.37
524675-2467524.97024.97
622556-2255622.82622.83
10min132179-3217932.56433.498.2132.8133.728.29
229342-2934229.69329.86
336439-3643936.87537.16
431252-3125231.62631.81
535773-3577336.20136.48
633570-3357033.97134.22
15min139211-3921139.68039.704.2340.2940.314.35
236399-3639936.83437.34
340667-4066741.15341.85
438497-3849738.95739.49
540952-4095241.44242.12
639659-3965940.13340.76
20min141907-4190742.40842.922.3343.4643.972.47
240811-4081141.29942.21
343710-4371044.23245.39
442396-4239642.90343.87
542752-4275243.26344.40
642917-4291743.43044.51
30min147023-4702347.58547.541.5149.1149.071.54
245882-4588246.43047.80
346386-4638646.94048.59
447496-4749648.06449.51
547450-4745048.01749.64
647644-4764448.21349.77
45min148621-4862149.20249.191.4051.2551.251.39
248612-4861249.19351.08
347798-4779848.36950.54
447926-4792648.49950.48
549224-4922449.81251.97
649496-4949650.08852.18
60min150919-5091951.52850.691.1454.1253.291.11
249684-4968450.27852.71
349338-4933849.92852.64
449973-4997350.57053.09
550137-5013750.73653.44
650505-5050551.10953.76
90min149356-4935649.94650.211.3653.1253.381.31
250264-5026450.86553.86
350218-5021850.81854.08
448616-4861649.19752.27
549159-4915949.74753.02
650077-5007750.67653.90
120min152139-5213952.76252.471.1756.4956.191.21
251570-5157052.18655.74
352165-5216552.78956.62
451036-5103651.64655.27
551460-5146052.07555.90
652717-5271753.34757.13
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152190-5219052.81451.531.2857.1255.831.24
250671-5067151.27755.41
350774-5077451.38155.79
450366-5036650.96855.17
550944-5094451.55355.96
650574-5057451.17955.55
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