布瑞哌唑口服混悬液项目信息
介质体积(ml)900.取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
111.058026380208803998036480132802730.14
211.088037880395803860.02
单位质量响应值RSD%判断
7264.527255.050.10数据可信
供试品溶液-2821374批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min137877-3787746.72250.756.9546.7250.756.95
245843-4584356.54856.55
342476-4247652.39452.39
441753-4175351.50351.50
539094-3909448.22348.22
639832-3983249.13349.13
15min167213-6721382.90884.484.7583.4385.054.73
272570-7257089.51690.14
369604-6960485.85786.44
462914-6291477.60578.18
569921-6992186.24886.78
668725-6872584.77385.32
20min169863-6986386.17788.572.0387.6290.082.04
273862-7386291.10992.73
371262-7126287.90289.44
472729-7272989.71291.15
572365-7236589.26390.76
670758-7075887.28188.77
30min172350-7235089.24492.732.4591.6495.222.48
278070-7807096.30098.94
375729-7572993.41295.93
474967-7496792.47294.90
575261-7526192.83595.32
674694-7469492.13694.59
45min174469-7446991.85893.431.8995.2596.951.89
277643-7764395.77399.48
375126-7512692.66896.22
477244-7724495.28198.74
575765-7576593.45796.97
674228-7422891.56195.04
60min175024-7502492.54395.092.0996.9599.652.10
279847-7984798.492103.26
376983-7698394.95999.54
476591-7659194.47698.99
576440-7644094.28998.85
677665-7766595.800100.30
极限163902-6390278.82492.697.7484.2698.307.41
280713-8071399.560105.42
375766-7576693.45899.09
476554-7655494.430100.00
578066-7806696.295101.90
675866-7586693.58199.14
布瑞哌唑口服混悬液项目信息
介质体积(ml)900.取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2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%
111.058019079886803688013480149801450.22
211.088041780761805890.31
单位质量响应值RSD%判断
7252.947273.380.20数据可信
供试品溶液-2810778批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min138677-3867747.68647.649.1647.6947.659.16
238649-3864947.65247.65
336350-3635044.81744.82
443325-4332553.41753.42
533401-3340141.18141.18
641458-4145851.11551.12
15min168500-6850084.45685.193.5784.9985.723.59
266635-6663582.15782.69
367451-6745183.16383.66
473410-7341090.51091.10
568155-6815584.03184.49
670398-7039886.79687.36
20min170665-7066587.12688.012.4288.5989.492.40
272931-7293189.91991.36
368376-6837684.30385.73
471442-7144288.08389.68
571860-7186088.59989.99
673025-7302590.03591.57
30min175169-7516992.67992.213.3395.1194.663.32
273142-7314290.17992.62
370802-7080287.29489.65
477248-7724895.24297.82
575119-7511992.61794.99
677230-7723095.22097.75
45min175990-7599093.69193.593.2497.1697.073.16
273300-7330090.37493.82
373343-7334390.42793.76
476949-7694994.87398.51
579876-7987698.482101.89
675982-7598293.68197.27
60min176566-7656694.40195.815.6498.91100.335.48
273702-7370290.87095.32
374358-7435891.67996.01
479743-7974398.318103.01
576365-7636594.15398.65
685538-85538105.463110.09
极限176226-7622693.98293.553.0499.5499.133.03
273366-7336690.45695.91
372716-7271689.65495.01
477733-7773395.840101.62
576986-7698694.919100.46
678208-7820896.426102.23
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