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%
111.159838498523983529821098391983720.12
211.029845498461984580.01
单位质量响应值RSD%判断
8822.608934.480.90数据可信
加速6月-供试品溶液-2025051321批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123392-2339223.65831.3915.2823.6631.3915.28
237066-3706637.48837.49
334639-3463935.03335.03
430762-3076231.11231.11
531410-3141031.76831.77
628947-2894729.27729.28
10min150576-5057651.15260.419.0751.4160.769.11
264002-6400264.73165.15
365411-6541166.15666.55
458631-5863159.29959.64
562240-6224062.94963.30
657528-5752858.18358.51
15min165503-6550366.24973.855.9767.0874.876.03
274852-7485275.70476.84
378579-7857979.47480.60
471687-7168772.50373.51
574557-7455775.40676.46
672907-7290773.73774.71
20min174921-7492175.77481.104.0077.3482.944.10
280885-8088581.80683.78
384173-8417385.13287.14
479723-7972380.63182.44
582507-8250783.44785.34
678887-7888779.78581.58
30min185586-8558686.56187.040.8188.9789.780.91
287333-8733388.32891.21
385765-8576586.74289.70
486239-8623987.22189.93
586041-8604187.02189.84
685389-8538986.36189.04
45min188707-8870789.71789.341.0993.0993.051.04
287125-8712588.11791.98
388671-8867189.68193.60
489164-8916490.17993.85
589213-8921390.22994.01
687146-8714688.13891.78
60min188561-8856189.57089.601.5093.9494.301.46
288458-8845889.46594.31
388459-8845989.46694.38
490611-9061191.64396.32
588973-8897389.98694.77
686474-8647487.45992.08
90min185571-8557186.54688.411.4491.9194.111.50
288669-8866989.67995.52
387186-8718688.17994.09
489008-8900890.02295.72
587148-8714888.14093.93
686902-8690287.89293.48
120min187245-8724588.23987.241.0994.5693.920.96
287191-8719188.18495.02
385327-8532786.29993.19
486811-8681187.80094.50
585697-8569786.67393.44
685244-8524486.21592.78
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188795-8879589.80690.421.5997.1198.071.56
290470-9047091.50099.32
391376-9137692.417100.26
488795-8879589.80697.48
587360-8736088.35596.08
689634-8963490.65598.18
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%
111.159814298446984829858198409984120.17
211.029930299298993000.01
单位质量响应值RSD%判断
8826.199010.891.47数据可信
加速6月-供试品溶液-2025051321批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131860-3186032.08032.5714.6532.0832.5714.65
229817-2981730.02330.02
335218-3521835.46235.46
438709-3870938.97738.98
524911-2491125.08325.08
633571-3357133.80333.80
10min161188-6118861.61161.317.0461.9761.677.08
256379-5637956.76957.10
365352-6535265.80466.20
465086-6508665.53665.97
555205-5520555.58755.87
662110-6211062.54062.92
15min174706-7470675.22374.623.0376.2675.663.09
271390-7139071.88472.85
377855-7785578.39479.52
474454-7445474.96976.13
572309-7230972.80973.71
673907-7390774.41975.49
20min181591-8159182.15681.672.1284.0383.542.21
279905-7990580.45882.22
383099-8309983.67485.67
482771-8277183.34485.34
578653-7865379.19780.90
680627-8062781.18583.08
30min185828-8582886.42287.792.7089.2190.572.50
289445-8944590.06492.72
387325-8732587.92990.86
484348-8434884.93287.85
590425-9042591.05193.64
685728-8572886.32189.12
45min189173-8917389.79089.972.6193.5493.722.43
289177-8917789.79493.45
390215-9021590.83994.74
485431-8543186.02289.89
592654-9265493.29596.89
689443-8944390.06293.82
60min189331-8933189.94990.222.2994.7094.982.15
288818-8881889.43394.09
390941-9094191.57096.48
486614-8661487.21392.03
592673-9267393.31497.95
689230-8923089.84894.61
90min184540-8454085.12588.112.9590.8793.872.75
289115-8911589.73295.38
388825-8882589.44095.37
484671-8467185.25791.05
590947-9094791.57697.25
686947-8694787.54993.31
120min188589-8858989.20287.862.0495.8994.601.90
286804-8680487.40594.05
388138-8813888.74895.67
483959-8395984.54091.28
588690-8869089.30495.99
687362-8736287.96794.70
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190055-9005590.67890.061.6298.3697.771.51
288604-8860489.21796.83
389904-8990490.52698.44
491377-9137792.00999.68
589567-8956790.18797.87
687115-8711587.71895.43
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