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%
111.331009121017891010501012581011601012340.34
211.341011621012871012240.09
单位质量响应值RSD%判断
8935.048926.280.07数据可信
供试品溶液-2025051521批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min128748-2874828.90525.359.0428.9025.359.03
224640-2464024.77424.77
322914-2291423.03923.04
425598-2559825.73725.74
526588-2658826.73326.73
622807-2280722.93122.93
10min136463-3646336.66236.102.7936.9836.382.81
234247-3424734.43434.71
335343-3534335.53635.79
436918-3691837.11937.41
536670-3667036.87037.17
635776-3577635.97136.23
15min141419-4141941.64540.621.7042.3741.301.73
240094-4009440.31240.97
339630-3963039.84640.50
440053-4005340.27140.97
541047-4104741.27141.98
640141-4014140.36041.01
20min145420-4542045.66743.502.8046.8644.642.79
242128-4212842.35743.46
342925-4292543.15944.25
442235-4223542.46543.61
543173-4317343.40844.57
643719-4371943.95745.06
30min147838-4783848.09946.492.5949.8048.112.56
244726-4472644.97046.55
345692-4569245.94147.51
446285-4628546.53748.15
545464-4546445.71247.36
647424-4742447.68249.27
45min147134-4713447.39148.281.3849.6250.421.30
248097-4809748.35950.44
347319-4731947.57749.66
448345-4834548.60850.74
548809-4880949.07551.23
648432-4843248.69650.82
60min148601-4860148.86649.661.2851.6352.331.18
249492-4949249.76252.37
348889-4888949.15551.77
450207-5020750.48053.16
549166-4916649.43452.13
650006-5000650.27852.94
90min150097-5009750.37051.042.2453.6754.272.04
252557-5255752.84356.01
350992-5099251.27054.43
449173-4917349.44152.68
550615-5061550.89154.14
651175-5117551.45454.67
120min150372-5037250.64651.221.6454.5155.011.51
250469-5046950.74454.50
351559-5155951.84055.57
452050-5205052.33456.12
551343-5134351.62355.44
649864-4986450.13653.93
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150629-5062950.90551.560.9155.3355.920.77
251486-5148651.76656.08
351847-5184752.12956.43
451502-5150251.78356.15
550801-5080151.07855.47
651423-5142351.70356.05
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%
111.331018741014591013291012991008921013710.35
211.341035301034041034670.09
单位质量响应值RSD%判断
8947.139124.071.39数据可信
供试品溶液-2025051622批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min126593-2659326.43024.316.1726.4324.326.16
223109-2310922.96722.97
323864-2386423.71823.72
422817-2281722.67722.68
524551-2455124.40024.40
625850-2585025.69125.69
10min136453-3645336.22934.722.4136.5234.992.44
234386-3438634.17534.43
334602-3460234.39034.65
434326-3432634.11534.37
534447-3444734.23634.51
635403-3540335.18635.47
15min140857-4085740.60640.061.2641.3040.711.25
239596-3959639.35339.99
340569-4056940.32040.97
440784-4078440.53441.16
540029-4002939.78340.43
640003-4000339.75840.43
20min143264-4326442.99942.451.2444.1543.551.25
242295-4229542.03543.11
343401-4340143.13544.23
442120-4212041.86242.94
542760-4276042.49843.59
642426-4242642.16643.28
30min145790-4579045.50945.710.7047.1347.280.66
245610-4561045.33046.87
346073-4607345.79047.36
446341-4634146.05747.60
546368-4636846.08347.65
645765-4576545.48447.07
45min146868-4686846.58047.211.7448.7149.291.66
246479-4647946.19448.24
348751-4875148.45250.53
448111-4811147.81649.87
547436-4743647.14549.22
647384-4738447.09349.19
60min148570-4857048.27248.093.1950.9250.703.01
248608-4860848.31050.87
346848-4684846.56149.18
451152-5115250.83853.43
547088-4708846.79949.40
648075-4807547.78050.40
90min150395-5039550.08649.732.2153.2752.862.09
250178-5017849.87052.96
348028-4802847.73350.87
451383-5138351.06854.22
549934-4993449.62852.75
650277-5027749.96953.11
120min150281-5028149.97251.241.7953.7154.941.66
252022-5202251.70355.35
351968-5196851.64955.32
452873-5287352.54956.27
550888-5088850.57654.25
651322-5132251.00754.71
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150019-5001949.71250.491.3354.0154.751.18
251547-5154751.23155.45
351695-5169551.37855.62
450438-5043850.12954.43
550648-5064850.33754.57
650444-5044450.13454.40
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