布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
111.158471684725850468479984718848010.17
211.128425784101841790.14
单位质量响应值RSD%判断
7605.477570.050.34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%
10min152799-5279962.31364.693.9862.3164.693.98
254540-5454064.36864.37
355881-5588165.95165.95
451806-5180661.14161.14
556413-5641366.57866.58
657439-5743967.78967.79
15min169351-6935181.84880.122.8482.1980.482.83
266429-6642978.39978.76
366954-6695479.01979.39
465779-6577977.63277.97
567940-6794080.18380.55
670870-7087083.64184.02
20min171009-7100983.80583.182.1184.6183.982.12
270165-7016582.80883.60
369324-6932481.81682.62
468788-6878881.18381.95
570558-7055883.27284.09
673021-7302186.17987.02
30min173507-7350786.75385.912.6488.0287.172.63
272838-7283885.96387.22
369683-6968382.24083.50
471716-7171684.63985.86
573709-7370986.99188.27
675287-7528788.85390.17
45min172430-7243085.48287.643.2887.2389.383.25
275093-7509388.62490.36
371277-7127784.12185.84
472963-7296386.11187.80
576169-7616989.89491.66
677613-7761391.59993.41
60min172936-7293686.07988.712.3388.3090.942.32
274729-7472988.19590.42
374503-7450387.92890.11
474838-7483888.32490.49
575827-7582789.49191.75
678178-7817892.26594.59
极限175608-7560889.23290.522.7091.9393.242.69
277091-7709190.98393.70
374226-7422687.60190.27
475482-7548289.08491.74
577744-7774491.75394.51
680057-8005794.48397.32
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