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%
111.169824498207978239789798194980730.21
211.179766897388975280.21
单位质量响应值RSD%判断
8787.908731.240.46数据可信
供试品溶液-02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%
5min118854-1885419.32720.0911.4819.3320.0911.49
221733-2173322.27822.28
316437-1643716.84916.85
421723-2172322.26822.27
517745-1774518.19018.19
621097-2109721.62621.63
10min138105-3810539.06139.526.5739.2839.746.59
239783-3978340.78141.03
334777-3477735.65035.84
441915-4191542.96743.21
536842-3684237.76737.97
639903-3990340.90441.14
15min149736-4973650.98451.723.4951.6352.393.55
251736-5173653.03453.73
348183-4818349.39249.98
452910-5291054.23854.96
549124-4912450.35750.98
651061-5106152.34253.04
20min155015-5501556.39656.801.7057.6158.041.77
256059-5605957.46658.76
355024-5502456.40557.54
456933-5693358.36259.69
554257-5425755.61956.80
655180-5518056.56557.84
30min163914-6391465.51865.151.9167.3667.011.97
264761-6476166.38668.31
361555-6155563.10064.86
464651-6465166.27368.25
562807-6280764.38366.18
663620-6362065.21767.12
45min169742-6974271.49272.160.8974.0674.750.94
270907-7090772.68675.35
370635-7063572.40874.87
471130-7113072.91575.63
569586-6958671.33273.85
670340-7034072.10574.73
60min170380-7038072.14675.052.1375.5178.442.08
274196-7419676.05879.53
374157-7415776.01879.28
474051-7405175.90979.43
572360-7236074.17677.48
674107-7410775.96779.40
90min175935-7593577.84179.211.7882.0183.441.77
278542-7854280.51384.83
378258-7825880.22284.33
478433-7843380.40184.77
575354-7535477.24581.38
677084-7708479.01883.29
极限179624-7962481.62281.501.9086.6586.611.82
281544-8154483.59088.80
380658-8065882.68287.68
479587-7958781.58486.84
578070-7807080.02985.02
677547-7754779.49384.65
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)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%
111.169755897409973859735597836975090.21
211.179813497936980350.15
单位质量响应值RSD%判断
8737.378776.630.32数据可信
供试品溶液-02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%
5min121795-2179522.34821.5911.5322.3521.5911.54
224615-2461525.24025.24
321453-2145321.99822.00
421446-2144621.99121.99
519749-1974920.25020.25
617284-1728417.72317.72
10min140320-4032041.34440.524.4141.5940.764.45
241923-4192342.98743.27
339790-3979040.80041.04
439614-3961440.62040.86
538762-3876239.74639.97
636681-3668137.61237.81
15min149852-4985251.11850.582.3551.8351.272.40
251045-5104552.34153.10
349538-4953850.79651.49
448472-4847249.70350.40
549368-4936850.62151.29
647684-4768448.89549.51
20min155439-5543956.84757.141.1058.1258.391.06
256029-5602957.45258.79
355515-5551556.92558.19
455983-5598357.40458.65
554807-5480756.19957.43
656586-5658658.02359.18
30min160363-6036361.89662.621.3563.8064.501.24
260481-6048162.01763.99
360324-6032461.85663.75
461346-6134662.90464.79
561520-6152063.08264.94
662362-6236263.94565.75
45min166307-6630767.99168.891.9670.5971.471.87
266715-6671568.40971.08
367242-6724268.94971.53
468508-6850870.24772.83
565444-6544467.10669.66
668877-6887770.62673.14
60min170370-7037072.15773.851.9975.5177.201.88
271232-7123273.04176.47
372010-7201073.83877.19
472356-7235674.19377.56
571582-7158273.40076.70
674584-7458476.47879.78
90min171933-7193373.75976.072.0377.9180.241.92
272723-7272374.56978.81
375291-7529177.20381.37
475668-7566877.58981.78
574676-7467676.57280.69
674848-7484876.74880.90
极限175356-7535677.26978.791.6682.2483.801.58
277350-7735079.31484.38
376069-7606978.00083.03
477515-7751579.48384.53
575938-7593877.86682.83
678780-7878080.78085.78
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%
111.169758297309974609743897200973980.16
211.179802798009980180.02
单位质量响应值RSD%判断
8727.428775.110.39数据可信
供试品溶液-02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%
5min118858-1885819.35021.266.8619.3521.266.87
221651-2165122.21522.22
322908-2290823.50523.51
419957-1995720.47720.48
520100-2010020.62420.62
620835-2083521.37821.38
10min136596-3659637.55039.452.4637.7639.692.48
239263-3926340.28640.53
338849-3884939.86240.12
438493-3849339.49639.72
538678-3867839.68639.92
638819-3881939.83140.07
15min145152-4515246.32947.642.1846.9648.312.17
247069-4706948.29648.99
345501-4550146.68747.39
447340-4734048.57449.24
547517-4751748.75649.43
645983-4598347.18247.86
20min151510-5151052.85353.482.2854.0054.682.25
252761-5276154.13655.37
351299-5129952.63653.86
450838-5083852.16353.37
554108-5410855.51856.73
652191-5219153.55154.76
30min158832-5883260.36561.021.1962.1062.821.16
259754-5975461.31163.14
359322-5932260.86862.68
460727-6072762.31064.10
558875-5887560.41062.24
659303-5930360.84962.65
45min164334-6433466.01167.201.3368.4269.681.32
265466-6546667.17269.69
365081-6508166.77769.26
465192-6519266.89169.37
566848-6684868.59071.09
666056-6605667.77870.25
60min168300-6830070.08070.881.1773.2274.101.15
270206-7020672.03675.30
368262-6826270.04173.27
469550-6955071.36374.58
568600-6860070.38873.65
669568-6956871.38174.61
90min171700-7170073.56975.401.3277.4979.411.31
274529-7452976.47280.53
373267-7326775.17779.18
473979-7397975.90779.92
573708-7370875.62979.67
673729-7372975.65179.67
极限174846-7484676.79776.052.5981.5380.902.42
271376-7137673.23678.15
372567-7256774.45879.30
473916-7391675.84380.70
576610-7661078.60783.49
675394-7539477.35982.22
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