氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.191800341800681800421801531804581801510.10
214.301785261782011783640.13
单位质量响应值RSD%判断
12695.6312473.011.26数据可信
供试品溶液-2011707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%
2min151957-5195729.20629.2511.8129.2129.2511.82
256672-5667231.85631.86
349573-4957327.86527.87
453370-5337030.00030.00
559057-5905733.19733.20
641545-4154523.35323.35
5min1108880-10888061.20363.543.4661.2063.543.46
2117627-11762766.11966.12
3115546-11554664.95064.95
4111410-11141062.62562.62
5116107-11610765.26565.26
6108626-10862661.06061.06
10min1124532-12453270.00172.632.6570.0072.632.65
2127337-12733771.57771.58
3132685-13268574.58474.58
4127043-12704371.41271.41
5132996-13299674.75874.76
6130637-13063773.43273.43
15min1131498-13149873.91676.381.9373.9276.381.93
2134582-13458275.65075.65
3138637-13863777.92977.93
4136361-13636176.65076.65
5135984-13598476.43876.44
6138214-13821477.69177.69
20min1134220-13422075.44678.012.6775.4578.012.67
2137602-13760277.34777.35
3142200-14220079.93279.93
4138629-13862977.92577.92
5143973-14397380.92980.93
6136043-13604376.47176.47
30min1143805-14380580.83480.013.1380.8380.013.13
2135787-13578776.32776.33
3143098-14309880.43780.44
4145801-14580181.95681.96
5138231-13823177.70177.70
6147303-14730382.80182.80
45min1146877-14687782.56182.271.5982.5682.271.59
2142961-14296180.36080.36
3147191-14719182.73882.74
4149420-14942083.99083.99
5144344-14434481.13781.14
6147397-14739782.85382.85
60min1141579-14157979.58382.712.3779.5882.712.37
2149208-14920883.87183.87
3146659-14665982.43982.44
4144879-14487981.43881.44
5149833-14983384.22384.22
6150736-15073684.73084.73
90min1148731-14873183.60384.330.7783.6084.320.77
2148732-14873283.60483.60
3151307-15130785.05185.05
4149670-14967084.13184.13
5150604-15060484.65684.66
6151059-15105984.91284.91
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1149211-14921183.87383.901.6183.8783.901.61
2146508-14650882.35482.35
3146515-14651582.35882.36
4151963-15196385.42085.42
5149652-14965284.12184.12
6151719-15171985.28385.28
极限1144790-14479081.38882.472.0381.3982.472.03
2145383-14538381.72181.72
3149635-14963584.11184.11
4142898-14289880.32480.32
5146961-14696182.60882.61
6150658-15065884.68684.69
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.191787941787631787141786031790701787890.10
214.301790671787451789060.13
单位质量响应值RSD%判断
12599.6512510.910.50数据可信
供试品溶液-2011707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%
2min166280-6628037.34037.933.2237.3437.933.22
263828-6382835.95935.96
369632-6963239.22939.23
467463-6746338.00738.01
569496-6949639.15239.15
667274-6727437.90037.90
5min1108549-10854961.15463.973.3261.1563.963.32
2115325-11532564.97164.97
3110235-11023562.10362.10
4118045-11804566.50366.50
5116736-11673665.76665.77
6112362-11236263.30263.30
10min1132145-13214574.44774.972.8474.4574.982.84
2126677-12667771.36671.37
3134130-13413075.56575.57
4135663-13566376.42976.43
5137652-13765277.54977.55
6132201-13220174.47974.48
15min1142178-14217880.09979.771.6980.1079.771.69
2137529-13752977.48077.48
3142825-14282580.46480.46
4140189-14018978.97978.98
5144324-14432481.30881.31
6142476-14247680.26780.27
20min1141055-14105579.46781.833.6979.4781.833.69
2143803-14380381.01581.01
3148501-14850183.66183.66
4150601-15060184.84584.84
5150123-15012384.57584.58
6137453-13745377.43777.44
30min1139713-13971378.71185.384.0378.7185.384.03
2152210-15221085.75185.75
3152659-15265986.00486.00
4154254-15425486.90386.90
5157423-15742388.68888.69
6153049-15304986.22486.22
45min1154754-15475487.18487.901.9187.1887.901.91
2158447-15844789.26589.26
3158769-15876989.44689.45
4157182-15718288.55288.55
5156278-15627888.04388.04
6150760-15076084.93484.93
60min1152608-15260885.97587.702.7085.9887.702.70
2149790-14979084.38884.39
3157718-15771888.85488.85
4159832-15983290.04590.05
5160111-16011190.20290.20
6153953-15395386.73386.73
90min1151987-15198785.62588.602.0685.6388.602.05
2155779-15577987.76287.76
3157234-15723488.58188.58
4159243-15924389.71389.71
5161459-16145990.96290.96
6157952-15795288.98688.99
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1155854-15585487.80487.453.4687.8087.453.47
2155565-15556587.64187.64
3158921-15892189.53289.53
4154427-15442787.00087.00
5161094-16109490.75690.76
6145489-14548981.96581.96
极限1151326-15132685.25387.112.0985.2587.112.10
2149865-14986584.43084.43
3155626-15562687.67687.68
4157300-15730088.61988.62
5157486-15748688.72388.72
6156151-15615187.97187.97
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