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%
111.331004691005191008161004331003601005190.18
211.341006971006051006510.07
单位质量响应值RSD%判断
8871.938875.750.04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%
5min126571-2657126.88727.363.5426.8927.363.54
226839-2683927.15827.16
328461-2846128.79928.80
427179-2717927.50227.50
525621-2562125.92525.93
627554-2755427.88127.88
10min136469-3646936.90236.892.2737.2037.202.28
236934-3693437.37337.67
337436-3743637.88138.20
435852-3585236.27836.58
535166-3516635.58435.87
636899-3689937.33837.65
15min140691-4069141.17541.181.1541.8841.891.16
240620-4062041.10341.82
340875-4087541.36142.10
440977-4097741.46442.17
539836-3983640.30940.99
641169-4116941.65842.38
20min142907-4290743.41743.001.4344.5844.181.44
242480-4248042.98544.16
343343-4334343.85845.06
442313-4231342.81643.99
541544-4154442.03843.17
642412-4241242.91644.10
30min143626-4362644.14444.541.1045.7946.181.06
243678-4367844.19745.85
343860-4386044.38146.07
444934-4493445.46847.11
543893-4389344.41546.01
644093-4409344.61746.28
45min146649-4664947.20346.611.2549.3448.751.18
245228-4522845.76647.91
346200-4620046.74948.93
445480-4548046.02048.17
546469-4646947.02149.11
646332-4633246.88349.04
60min145951-4595146.49746.990.9049.1649.650.86
247120-4712047.68050.33
346731-4673147.28649.99
446274-4627446.82449.49
546268-4626846.81849.43
646287-4628746.83749.52
90min147055-4705547.61447.981.0950.7951.161.01
247126-4712647.68650.87
347998-4799848.56851.79
447670-4767048.23751.42
547895-4789548.46451.60
646730-4673047.28550.49
120min148468-4846849.04448.481.5352.7552.201.45
247856-4785648.42552.14
348916-4891649.49753.26
446770-4677047.32651.04
547701-4770148.26851.94
647778-4777848.34652.07
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147376-4737647.93947.960.8052.1952.220.69
247375-4737547.93852.19
346778-4677847.33451.65
447373-4737347.93652.18
547564-4756448.12952.34
647936-4793648.50652.77
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%
111.33100379100390999961002011000791002090.18
211.341012361013981013170.12
单位质量响应值RSD%判断
8844.578934.480.72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%
5min125870-2587026.13228.036.3326.1328.026.33
227480-2748027.75827.76
326443-2644326.71126.71
429181-2918129.47629.48
527011-2701127.28427.28
630485-3048530.79430.79
10min136264-3626436.63137.532.8136.9237.842.83
237143-3714337.51937.83
336092-3609236.45736.75
438084-3808438.47038.80
536663-3666337.03437.34
638698-3869839.09039.43
15min140320-4032040.72841.071.2641.4341.801.30
240425-4042540.83441.56
340469-4046940.87941.58
440512-4051240.92241.68
540552-4055240.96341.68
641693-4169342.11542.89
20min141820-4182042.24342.950.9943.3944.141.00
242784-4278443.21744.40
342607-4260743.03844.19
443065-4306543.50144.71
542425-4242542.85544.02
642430-4243042.86044.10
30min143204-4320443.64144.962.6545.2646.622.58
243772-4377244.21545.87
344648-4464845.10046.73
446394-4639446.86448.56
545259-4525945.71747.36
643761-4376144.20445.92
45min146556-4655647.02746.550.7749.1348.710.71
245630-4563046.09248.24
345887-4588746.35248.49
446237-4623746.70548.92
546337-4633746.80648.96
645840-4584046.30448.52
60min145755-4575546.21846.941.9948.8449.621.96
245543-4554346.00448.67
346286-4628646.75549.41
448030-4803048.51651.25
546159-4615946.62649.30
647023-4702347.49950.23
90min147728-4772848.21148.061.3351.3551.261.20
247935-4793548.42051.59
347191-4719147.66950.84
447111-4711147.58850.86
548588-4858849.08052.27
646898-4689847.37350.63
120min146187-4618746.65547.581.1150.3351.321.09
247232-4723247.71051.42
347242-4724247.72051.42
447657-4765748.14051.94
547448-4744847.92851.67
646870-4687047.34551.12
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147730-4773048.21348.031.1752.4152.291.06
247388-4738847.86852.11
347308-4730847.78752.02
447589-4758948.07152.41
548465-4846548.95653.23
646797-4679747.27151.58
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%
111.331015431015421015551016401016031015770.05
211.341005551004861005200.05
单位质量响应值RSD%判断
8965.318864.200.81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%
5min127188-2718827.38625.876.8527.3925.876.86
226128-2612826.31826.32
323223-2322323.39223.39
427665-2766527.86627.87
525942-2594226.13126.13
623966-2396624.14024.14
10min137405-3740537.67736.243.1037.9836.533.13
236290-3629036.55436.85
334761-3476135.01435.27
436587-3658736.85337.16
536302-3630236.56636.86
634524-3452434.77535.04
15min140116-4011640.40840.422.2041.1341.112.23
240393-4039340.68741.39
339066-3906639.35040.00
441037-4103741.33542.05
541034-4103441.33242.03
639115-3911539.39940.05
20min142938-4293843.25042.681.7244.4243.821.76
242730-4273043.04144.19
341106-4110641.40542.49
443073-4307343.38644.56
542372-4237242.68043.84
642036-4203642.34243.43
30min144225-4422544.54744.770.5346.2046.390.49
244708-4470845.03346.66
344737-4473745.06246.61
444493-4449344.81746.48
544237-4423744.55946.19
644296-4429644.61846.18
45min144745-4474545.07046.111.4547.2248.221.39
245528-4552845.85947.99
345519-4551945.85047.90
446505-4650546.84349.00
546442-4644246.78048.90
645899-4589946.23348.29
60min147630-4763047.97647.011.1450.6249.631.10
246488-4648846.82649.46
346704-4670447.04449.60
446215-4621546.55149.23
546785-4678547.12549.77
646196-4619646.53249.10
90min146240-4624046.57647.401.3149.7650.551.20
247275-4727547.61950.78
347960-4796048.30951.39
447327-4732747.67150.87
547032-4703247.37450.54
646537-4653746.87549.96
120min148874-4887449.22948.551.4552.9352.221.31
247418-4741847.76351.45
349132-4913249.48953.11
447503-4750347.84851.57
548086-4808648.43652.13
648170-4817048.52052.13
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147441-4744147.78648.061.1852.0352.271.11
246993-4699347.33551.55
347819-4781948.16752.33
448101-4810148.45152.71
548546-4854648.89953.13
647362-4736247.70651.86
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