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%
111.088431283696842218400383922840310.30
2 10.968370183794837480.08
单位质量响应值RSD%判断
7584.037641.240.54数据可信
供试品溶液-25062301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%
10min133972-3397239.96338.7111.0639.9638.7111.06
228142-2814233.10533.10
338845-3884545.69545.70
434018-3401840.01740.02
530887-3088736.33436.33
631597-3159737.16937.17
15min159891-5989170.45372.204.4470.6772.424.44
260109-6010970.70970.89
364816-6481676.24676.50
462765-6276573.83474.06
563276-6327674.43574.64
657402-5740267.52567.73
20min163962-6396275.24276.437.3975.8677.057.36
262741-6274173.80574.38
369947-6994782.28282.96
466004-6600477.64478.28
569904-6990482.23282.85
657299-5729967.40467.99
30min169479-6947981.73282.634.9782.7683.674.98
268880-6888081.02782.01
374512-7451287.65288.79
471278-7127883.84884.91
572776-7277685.61086.68
664532-6453275.91276.87
45min164765-6476576.18684.097.3277.6785.597.27
269609-6960981.88583.32
377034-7703490.61992.24
475148-7514888.40089.93
575848-7584889.22490.77
666512-6651278.24179.62
60min171687-7168784.32986.026.3186.2487.996.30
270842-7084283.33585.23
377374-7737491.01993.14
476709-7670990.23792.26
576531-7653190.02792.07
665598-6559877.16678.98
极限173944-7394486.98485.746.5489.3688.196.51
271151-7115183.69986.05
377750-7775091.46194.09
474683-7468387.85390.38
575585-7558588.91491.46
664216-6421675.54177.78
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%
111.088361083706834208347883481835390.14
2 10.968365483831837420.15
单位质量响应值RSD%判断
7539.627640.690.95数据可信
供试品溶液-25062301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%
10min135354-3535441.71339.395.1841.7139.395.19
231270-3127036.89536.89
335195-3519541.52641.53
434009-3400940.12640.13
532623-3262338.49138.49
631852-3185237.58137.58
15min162198-6219873.38672.283.1073.6272.503.10
261733-6173372.83773.04
363555-6355574.98775.22
461596-6159672.67572.90
560523-6052371.40971.62
657948-5794868.37168.58
20min164337-6433775.90978.472.4676.5579.102.45
266114-6611478.00678.62
369006-6900681.41882.07
467567-6756779.72080.35
565472-6547277.24877.86
666569-6656978.54379.13
30min171442-7144284.29284.581.8285.3585.641.81
269528-6952882.03483.08
372429-7242985.45786.56
473180-7318086.34387.41
572449-7244985.48086.52
671082-7108283.86884.89
45min173916-7391687.21186.991.8788.7488.521.87
271850-7185084.77486.27
374586-7458688.00289.58
475681-7568189.29490.84
573788-7378887.06088.57
672562-7256285.61487.10
60min173509-7350986.73188.162.4388.7490.172.40
272550-7255085.60087.57
376252-7625289.96792.03
475725-7572589.34691.39
576946-7694690.78692.78
673343-7334386.53588.50
极限173906-7390687.19987.142.7789.7089.642.73
270197-7019782.82385.27
374784-7478488.23590.80
476308-7630890.03492.58
574485-7448587.88390.39
673472-7347286.68789.13
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