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%
111.009710497041974979748197323972890.22
211.019695697005969800.04
单位质量响应值RSD%判断
8844.458808.360.29数据可信
中间条件3月-供试品溶液-2025051521批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147670-4767048.49643.6411.5448.5043.6411.54
243984-4398444.74644.75
344327-4432745.09545.10
433244-3324433.82033.82
544497-4449745.26845.27
643648-4364844.40444.40
10min170637-7063771.86167.948.2472.4068.438.26
269682-6968270.88971.39
366343-6634367.49367.99
456030-5603057.00157.38
567962-6796269.14069.64
670068-7006871.28271.78
15min178856-7885680.22278.194.3181.5679.424.38
279338-7933880.71382.00
376612-7661277.93979.19
470449-7044971.67072.68
578689-7868980.05281.32
677182-7718278.51979.80
20min182925-8292584.36282.952.5786.5985.062.68
283205-8320584.64786.83
380795-8079582.19584.31
477672-7767279.01880.82
582801-8280184.23686.40
681822-8182283.24085.40
30min184299-8429985.76087.801.2688.9390.831.20
287586-8758689.10492.23
386514-8651488.01391.04
486348-8634887.84490.53
586622-8662288.12391.22
686471-8647187.96991.05
45min187110-8711088.61990.611.4392.7494.611.28
290277-9027791.84195.95
389054-8905490.59794.61
490369-9036991.93595.59
588096-8809689.62293.70
689479-8947991.02995.09
60min186390-8639087.88790.612.2492.9995.622.04
291175-9117592.75597.89
388565-8856590.10095.11
491306-9130692.88897.57
589527-8952791.07896.15
687424-8742488.93994.01
90min185521-8552187.00388.321.4093.0894.341.26
288180-8818089.70895.87
385621-8562187.10593.12
488256-8825689.78595.50
586996-8699688.50394.59
686338-8633887.83493.89
120min185783-8578387.26989.801.5694.3296.801.40
289366-8936690.91498.07
387905-8790589.42896.41
489587-8958791.13997.85
588483-8848390.01697.08
688520-8852090.05497.09
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187557-8755789.07492.312.0797.09100.311.89
290763-9076392.336100.51
389820-8982091.37699.35
491823-9182393.414101.14
591551-9155193.137101.20
692903-9290394.513102.55
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%
111.009736097107972279708497243972040.12
211.019822397859980410.27
单位质量响应值RSD%判断
8836.738904.720.55数据可信
中间条件3月-供试品溶液-2025051621批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138732-3873239.20742.0810.2639.2142.0810.26
237620-3762038.08138.08
339820-3982040.30840.31
439933-3993340.42240.42
544504-4450445.04945.05
648843-4884349.44249.44
10min163600-6360064.37967.055.1364.8267.525.16
262645-6264563.41363.84
365507-6550766.31066.76
464836-6483665.63166.08
570591-7059171.45671.96
670267-7026771.12871.68
15min176280-7628077.21578.553.0478.3779.773.08
276149-7614977.08278.21
374928-7492875.84677.03
477479-7747978.42879.61
581143-8114382.13783.43
679642-7964280.61881.96
20min180587-8058781.57583.673.7883.5885.763.78
283505-8350584.52886.51
378067-7806779.02481.05
482189-8218983.19685.25
586944-8694488.00990.22
684648-8464885.68587.92
30min186879-8687987.94488.192.5990.8691.202.60
288195-8819589.27692.20
383317-8331784.33887.24
486564-8656487.62590.60
590141-9014191.24694.43
687615-8761588.68991.88
45min191414-9141492.53491.162.4496.4395.152.41
291142-9114292.25996.17
385976-8597687.03090.87
490242-9024291.34895.30
592072-9207293.20097.40
689485-8948590.58294.75
60min188442-8844289.52690.701.9894.4595.702.00
291489-9148992.61097.55
386995-8699588.06192.87
489046-8904690.13795.10
591406-9140692.52697.76
690214-9021491.32096.50
90min189562-8956290.66090.982.5496.5797.002.52
291771-9177192.89698.87
386526-8652687.58693.37
488992-8899290.08396.05
593051-9305194.191100.45
689367-8936790.46296.66
120min187605-8760588.67990.232.6895.6097.252.66
291608-9160892.73199.73
385560-8556086.60893.37
488372-8837289.45596.42
591497-9149792.61899.93
690168-9016891.27398.47
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189304-8930490.39892.061.4198.31100.101.49
291187-9118792.304100.34
389841-8984190.94298.67
490642-9064291.75399.71
592164-9216493.293101.63
692565-9256593.699101.91
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