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%
111.038140881580815528125981364814330.17
211.228185581517816860.30
单位质量响应值RSD%判断
7382.867280.390.99数据可信
供试品溶液-25090901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%
10min129147-2914735.60242.6820.1435.6042.6820.14
230367-3036737.09337.09
335049-3504942.81242.81
428323-2832334.59634.60
545227-4522755.24455.24
641533-4153350.73250.73
15min164589-6458978.89479.161.9479.2979.642.01
263946-6394678.10978.52
366227-6622780.89581.37
462895-6289576.82577.21
565348-6534879.82180.44
665852-6585280.43781.00
20min167383-6738382.30783.991.5883.5885.341.59
268603-6860383.79785.08
368503-6850383.67585.05
469767-6976785.21986.46
570279-7027985.84487.35
668010-6801083.07384.53
30min169547-6954784.95086.591.5687.1488.881.60
271604-7160487.46389.67
371157-7115786.91789.22
470058-7005885.57487.76
572549-7254988.61791.07
670430-7043086.02988.41
45min173234-7323489.45489.241.0892.5892.491.00
272429-7242988.47191.65
373818-7381890.16793.44
473458-7345889.72792.86
571793-7179387.69491.13
673617-7361789.92293.26
60min172261-7226188.26588.340.6092.3992.580.60
271937-7193787.87092.04
371974-7197487.91592.19
472894-7289489.03993.17
572825-7282588.95493.37
672034-7203487.98892.32
极限170682-7068286.33787.160.9391.4492.390.87
271068-7106886.80891.95
372089-7208988.05593.30
472288-7228888.29893.42
571065-7106586.80492.21
670969-7096986.68792.00
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%
111.038144081448813978158481198814130.18
211.228181581925818700.10
单位质量响应值RSD%判断
7381.057296.790.82数据可信
供试品溶液-25090901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%
10min145245-4524555.21041.3927.1255.2141.3927.11
235905-3590543.81343.81
319666-1966623.99724.00
441740-4174050.93350.93
531609-3160938.57138.57
629343-2934335.80635.81
15min163726-6372677.76177.231.9878.3777.692.09
263961-6396178.04878.54
362036-6203675.69975.97
465028-6502879.35079.92
563279-6327977.21677.64
661695-6169575.28375.68
20min171560-7156087.32185.202.6588.8086.522.70
271129-7112986.79588.15
370194-7019485.65486.76
470705-7070586.27887.73
568724-6872483.86085.15
666624-6662481.29882.53
30min175105-7510591.64788.472.3194.0990.732.33
272868-7286888.91791.24
373168-7316889.28391.34
471836-7183687.65890.06
571941-7194187.78690.00
670094-7009485.53287.67
45min175236-7523691.80690.522.0995.2793.772.11
276023-7602392.76796.07
374819-7481991.29894.35
474044-7404490.35293.73
573282-7328289.42292.62
671682-7168287.47090.56
60min171262-7126286.95786.151.4891.4490.411.55
271951-7195187.79892.14
369744-6974485.10589.17
470427-7042785.93890.32
571097-7109786.75690.94
669141-6914184.36988.43
极限174057-7405790.36887.992.3095.8293.202.36
273695-7369589.92695.24
371225-7122586.91291.92
472860-7286088.90794.25
570685-7068586.25391.40
670108-7010885.54990.55
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