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%
111.099885498784986689870398837987690.09
211.069974099636996880.08
单位质量响应值RSD%判断
8906.139013.380.85数据可信
供试品溶液-2025051221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%
5min119401-1940119.44425.5612.4719.4425.5612.48
226593-2659326.65226.65
328173-2817328.23528.24
427668-2766827.72927.73
525222-2522225.27825.28
625972-2597226.03026.03
10min145476-4547645.57751.886.6145.7952.166.64
253690-5369053.80954.11
355357-5535755.48055.79
451232-5123251.34651.65
553200-5320053.31853.60
651644-5164451.75952.05
15min161082-6108261.21763.963.0961.9464.823.15
263856-6385663.99864.89
367121-6712167.27068.20
463610-6361063.75164.63
564266-6426664.40865.28
662951-6295163.09163.95
20min167309-6730967.45869.963.9868.8671.533.98
268423-6842368.57570.18
373713-7371373.87675.55
470870-7087071.02772.61
571862-7186272.02173.61
666679-6667966.82768.39
30min175652-7565275.82077.464.3977.9779.814.35
276157-7615776.32678.69
380586-8058680.76583.26
479194-7919479.37081.75
580322-8032280.50082.89
671834-7183471.99374.30
45min180667-8066780.84683.385.2783.8486.595.19
281901-8190182.08385.30
385411-8541185.60089.00
487156-8715687.34990.61
587712-8771287.90691.19
676338-7633876.50779.62
60min185822-8582286.01286.505.1489.9190.645.05
284988-8498885.17689.30
389287-8928789.48593.83
489615-8961589.81494.04
589846-8984690.04594.31
678318-7831878.49282.45
90min189274-8927489.47289.374.5394.3294.464.48
286860-8686087.05392.13
392334-9233492.53997.88
492524-9252492.72997.96
591789-9178991.99397.25
682239-8223982.42187.25
120min189913-8991390.11288.903.4295.9694.993.40
287481-8748187.67593.72
390886-9088691.08897.46
491161-9116191.36397.62
589639-8963989.83896.12
683115-8311583.29989.05
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191331-9133191.53391.850.4998.3898.930.71
291824-9182492.02899.04
391667-9166791.87099.25
492133-9213392.33799.61
592002-9200292.20699.49
690939-9093991.14197.81
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%
111.099900398890988379894399148989640.13
211.069825897952981050.23
单位质量响应值RSD%判断
8923.728870.250.43数据可信
供试品溶液-2025051221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%
5min156170-5617056.69056.1913.5156.6956.1913.51
265030-6503065.63265.63
350110-5011050.57450.57
447581-4758148.02248.02
550839-5083951.31051.31
664332-6433264.92864.93
10min176914-7691477.62682.175.1978.2682.805.23
287152-8715287.95988.69
377192-7719277.90778.47
480272-8027281.01581.55
581441-8144182.19582.77
685525-8552586.31787.04
15min184787-8478785.57290.543.4487.0692.073.47
291911-9191192.76294.47
387031-8703187.83789.26
490542-9054291.38192.81
591595-9159592.44393.93
692360-9236093.21594.90
20min187773-8777388.58693.573.0791.0396.123.10
295304-9530496.18798.92
391085-9108591.92994.33
493089-9308993.95196.40
594558-9455895.43497.94
694478-9447895.35398.07
30min191063-9106391.90695.702.3695.3399.282.36
295280-9528096.16299.97
393333-9333394.19797.62
496965-9696597.863101.36
596572-9657297.466101.04
695701-9570196.587100.36
45min193784-9378494.65395.671.5099.10100.321.53
295027-9502795.907100.78
392653-9265393.51197.98
496733-9673397.629102.21
595079-9507995.960100.61
695500-9550096.384101.23
60min193133-9313393.99695.682.0099.50101.391.99
294636-9463695.512101.45
392195-9219593.04998.56
496556-9655697.450103.12
597028-9702897.927103.65
695278-9527896.160102.08
90min193816-9381694.68595.201.30101.23101.981.28
294379-9437995.253102.25
393151-9315194.014100.56
496675-9667597.570104.32
593769-9376994.637101.45
694185-9418595.057102.05
120min192498-9249893.35593.952.14100.95101.782.00
291710-9171092.559100.62
391083-9108391.92799.52
496409-9640997.302105.13
594477-9447795.352103.21
692374-9237493.229101.27
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192595-9259593.45393.151.86102.09102.031.73
291534-9153492.382101.47
390434-9043491.27299.88
495256-9525696.138105.05
592856-9285693.716102.64
691110-9111091.954101.03
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)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%
111.099826298633987399859998340985150.21
211.069933998980991600.26
单位质量响应值RSD%判断
8883.238965.640.66数据可信
供试品溶液-2025051221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%
5min113636-1363613.72026.9830.8013.7226.9830.80
224514-2451424.66524.67
323708-2370823.85423.85
435425-3542535.64435.64
535575-3557535.79435.79
628054-2805428.22728.23
10min137399-3739937.63052.0918.5237.7852.3818.58
246255-4625546.54046.81
348374-4837448.67248.94
461900-6190062.28262.68
561635-6163562.01562.41
655041-5504155.38155.69
15min152406-5240652.72965.2312.8853.3066.1113.01
259212-5921259.57760.37
361982-6198262.36463.17
473543-7354373.99775.08
572427-7242772.87473.96
669405-6940569.83370.76
20min162049-6204962.43272.9710.3563.5974.5810.51
266512-6651266.92268.38
369729-6972970.15971.66
480236-8023680.73182.64
579160-7916079.64881.54
677464-7746477.94279.65
30min172272-7227272.71881.507.4074.5783.917.60
275718-7571876.18578.38
380522-8052281.01983.30
485442-8544285.96988.78
584388-8438884.90987.69
687632-8763288.17390.74
45min182658-8265883.16886.934.0485.8390.254.19
283188-8318883.70186.74
387720-8772088.26191.44
485085-8508585.61089.37
587744-8774488.28592.01
691985-9198592.55296.10
60min184637-8463785.15988.503.4888.7492.793.55
286161-8616186.69390.67
390830-9083091.39095.55
487281-8728187.81992.53
586311-8631186.84391.55
692541-9254193.11297.69
90min186240-8624086.77289.312.6791.3094.582.65
290546-9054691.10596.04
389889-8988990.44495.62
488918-8891889.46795.16
585580-8558086.10891.78
691419-9141991.98397.60
120min191762-9176292.32889.913.3397.8296.182.83
291855-9185592.42298.37
389209-8920989.75995.94
486989-8698987.52694.21
584735-8473585.25891.89
691617-9161792.18298.82
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193141-9314193.71693.121.25100.23100.381.08
292571-9257193.142100.12
393175-9317593.750100.93
490526-9052691.08498.74
592088-9208892.656100.23
693802-9380294.381102.04
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