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%
111.308336483324834118328983435833650.08
211.288340783737835720.28
单位质量响应值RSD%判断
7377.437408.870.31数据可信
供试品溶液-25090903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%
10min132689-3268939.59546.6710.4639.5946.6710.46
239611-3961147.97947.98
338405-3840546.51946.52
438321-3832146.41746.42
545120-4512054.65254.65
637018-3701844.83844.84
15min161994-6199475.09178.923.2675.5379.443.28
265563-6556379.41479.95
364100-6410077.64278.16
464379-6437977.98078.50
567301-6730181.51982.13
667593-6759381.87382.37
20min166046-6604679.99985.113.4181.2786.503.42
269083-6908383.67885.09
370856-7085685.82587.20
471449-7144986.54387.93
571288-7128886.34887.86
672855-7285588.24689.65
30min174052-7405289.69690.811.6091.8693.151.60
276419-7641992.56394.91
375765-7576591.77194.10
474614-7461490.37792.72
575714-7571491.70994.18
673257-7325788.73391.12
45min170474-7047485.36291.093.1688.5294.443.14
276094-7609492.17095.54
375294-7529491.20194.55
476784-7678493.00696.35
576473-7647392.62996.12
676085-7608592.15995.53
60min171800-7180086.96987.431.8291.0891.791.77
274322-7432290.02394.42
370482-7048285.37289.74
472867-7286788.26192.64
572146-7214687.38891.91
671454-7145486.55090.95
极限170496-7049685.38985.722.1590.4691.052.02
267964-6796482.32287.72
372247-7224787.51092.82
471297-7129786.35991.72
570747-7074785.69391.18
671849-7184987.02892.39
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%
111.308352483614834228345483524835080.09
211.288348283463834720.02
单位质量响应值RSD%判断
7390.097400.000.10数据可信
供试品溶液-25090903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%
10min143226-4322652.34449.9119.0652.3449.9119.06
244221-4422153.54953.55
352340-5234063.38163.38
433768-3376840.89140.89
543115-4311552.21052.21
630613-3061337.07137.07
15min164726-6472678.38080.312.9378.9680.862.95
264029-6402977.53678.13
368161-6816182.53983.24
465453-6545379.26079.71
568933-6893383.47484.05
666635-6663580.69181.10
20min173098-7309888.51885.662.5689.9787.112.58
271359-7135986.41287.87
371859-7185987.01788.64
470759-7075985.68587.02
569299-6929983.91785.42
668079-6807982.44083.75
30min175545-7554591.48190.571.7293.9292.971.78
275994-7599492.02594.44
376244-7624492.32794.92
474053-7405389.67491.96
573503-7350389.00891.45
673427-7342788.91691.14
45min179038-7903895.71192.983.7999.1696.393.68
281337-8133798.495101.93
374561-7456190.28993.90
476773-7677392.96896.25
575207-7520791.07294.50
673800-7380089.36892.58
60min176422-7642292.54387.973.2797.0692.413.22
274338-7433890.01994.55
372010-7201087.20091.82
470828-7082885.76990.09
572343-7234387.60492.04
669957-6995784.71488.92
极限169877-6987784.61786.331.3690.1691.741.23
271479-7147986.55792.09
371843-7184386.99892.58
472652-7265287.97893.25
570631-7063185.53090.94
671247-7124786.27691.42
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