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%
111.089835298624983489841898315984110.13
211.169902398580988020.32
单位质量响应值RSD%判断
8881.868853.230.23数据可信
供试品溶液-2025032021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%
5min115776-1577615.97522.2340.1915.9722.2340.19
217807-1780718.03118.03
320673-2067320.93420.93
436418-3641836.87736.88
512814-1281412.97612.98
628216-2821628.57228.57
10min142550-4255043.08653.3618.5743.2653.6018.66
246472-4647247.05847.26
351695-5169552.34752.58
466741-6674167.58267.99
546182-4618246.76446.91
662508-6250863.29663.61
15min161616-6161662.39370.238.7663.0571.088.93
264526-6452665.33966.06
370487-7048771.37672.19
477469-7746978.44679.61
567264-6726468.11268.78
674797-7479775.74076.76
20min171951-7195172.85877.785.2474.2179.415.44
273075-7307573.99675.45
376164-7616477.12478.73
481332-8133282.35784.39
576839-7683977.80879.23
681536-8153682.56484.43
30min180713-8071381.73084.393.1883.8986.883.43
280468-8046881.48283.75
382726-8272683.76986.23
486172-8617287.25890.21
583241-8324184.29086.58
686732-8673287.82590.60
45min187047-8704788.14487.621.7891.2191.041.94
283988-8398885.04788.22
385325-8532586.40189.80
487667-8766788.77292.69
587223-8722388.32391.54
687909-8790989.01792.77
60min183214-8321484.26386.082.0388.3190.472.19
283181-8318184.23088.35
384552-8455285.61889.97
485218-8521886.29291.20
586422-8642287.51191.71
687450-8745088.55293.30
90min183827-8382784.88486.201.8789.8791.551.95
283344-8334484.39589.45
385487-8548786.56591.87
484280-8428085.34291.20
586464-8646487.55492.73
687374-8737488.47594.20
120min183196-8319684.24585.021.8490.1791.332.02
281823-8182382.85488.85
382980-8298084.02690.29
484730-8473085.79892.61
585086-8508686.15992.31
685944-8594487.02793.74
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184183-8418385.24487.522.1192.1194.782.22
285996-8599687.08094.00
388086-8808689.19696.40
486244-8624487.33195.09
585082-8508286.15593.26
689022-8902290.14497.82
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%
111.089848198413984989825898283983870.12
211.169812598316982200.14
单位质量响应值RSD%判断
8879.698801.080.63数据可信
供试品溶液-2025032021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%
5min116534-1653416.79416.179.6516.7916.179.65
216896-1689617.16217.16
314388-1438814.61414.61
413694-1369413.90913.91
516380-1638016.63816.64
617633-1763317.91017.91
10min152550-5255053.37749.518.4053.5649.698.39
251494-5149452.30452.49
345384-4538446.09846.26
444055-4405544.74844.90
545815-4581546.53646.72
653188-5318854.02554.22
15min172408-7240873.54768.816.3574.3369.546.37
270268-7026871.37472.15
365763-6576366.79867.47
461819-6181962.79263.44
564565-6456565.58166.28
671637-7163772.76473.56
20min176618-7661877.82376.394.2579.4277.884.29
277872-7787279.09780.66
374834-7483476.01177.43
471500-7150072.62573.97
571475-7147572.60074.03
678946-7894680.18881.80
30min184467-8446785.79684.222.6988.2686.562.75
283684-8368485.00187.44
384392-8439285.72087.98
479988-7998881.24783.40
580184-8018481.44683.68
684794-8479486.12888.63
45min184929-8492986.26587.601.2389.6890.871.20
285829-8582987.17990.57
386736-8673688.10191.31
486865-8686588.23291.29
585338-8533886.68189.82
687733-8773389.11392.57
60min185436-8543686.78087.001.7591.1591.251.74
285094-8509486.43390.79
387876-8787689.25993.45
484976-8497686.31390.35
583669-8366984.98589.09
686853-8685388.22092.67
90min185359-8535986.70286.962.0492.0492.182.03
284429-8442985.75791.07
386925-8692588.29393.48
485241-8524186.58291.58
583423-8342384.73689.79
688271-8827189.66095.09
120min185056-8505686.39486.022.1192.7092.212.04
283794-8379485.11291.38
386022-8602287.37593.54
486009-8600987.36293.32
581495-8149582.77788.77
685777-8577787.12793.55
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185209-8520986.55086.991.0593.8194.140.86
286018-8601887.37194.59
386228-8622887.58594.72
486841-8684188.20795.14
585253-8525386.59493.51
684332-8433285.65993.05
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