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%
1 11.088385683656839858393383847838550.15
2 10.968341083625835180.19
单位质量响应值RSD%判断
7568.147620.260.49数据可信
供试品溶液-2810778批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min129244-2924434.48529.8714.9034.4829.8714.89
225570-2557030.15230.15
326020-2602030.68330.68
428844-2884434.01334.01
523139-2313927.28627.29
619155-1915522.58822.59
15min144238-4423852.16650.476.9552.3650.646.96
246566-4656654.91155.08
340230-4023047.43947.61
445488-4548853.64053.83
539976-3997647.14047.29
640324-4032447.55047.68
30min152999-5299962.49760.603.7462.9861.043.77
252907-5290762.38862.86
349362-4936258.20858.64
453354-5335462.91563.40
550514-5051459.56659.98
649201-4920158.01858.41
45min160613-6061371.47568.793.1772.3069.583.19
259655-5965570.34571.16
356732-5673266.89967.66
459701-5970170.40071.24
556474-5647466.59467.34
656863-5686367.05367.77
60min164512-6451276.07374.421.6077.3075.581.61
263775-6377575.20476.41
362062-6206273.18474.31
462511-6251173.71374.94
562159-6215973.29874.41
663637-6363775.04176.13
90min169232-6923281.63981.231.5483.2982.811.57
268488-6848880.76182.39
368800-6880081.12982.66
470820-7082083.51185.15
568019-6801980.20881.73
667972-6797280.15381.65
120min174265-7426587.57486.001.3489.6888.031.37
272558-7255885.56187.64
371833-7183384.70686.69
473948-7394887.20089.30
572170-7217085.10387.07
672791-7279185.83587.78
极限176249-7624989.91387.391.8692.5089.901.86
273473-7347386.64089.19
372751-7275185.78888.25
474888-7488888.30890.89
572754-7275485.79288.23
674565-7456587.92790.35
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%
1 11.088395183552840818406783672838650.29
2 10.968455983488840240.91
单位质量响应值RSD%判断
7569.047666.420.91数据可信
供试品溶液-2810778批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min15081-50815.9736.278.445.976.278.45
24806-48065.6505.65
36031-60317.0907.09
45300-53006.2316.23
55090-50905.9845.98
65685-56856.6836.68
30min17484-74848.7989.228.288.839.268.28
26801-68017.9958.03
38529-852910.02710.07
48306-83069.7649.80
57669-76699.0169.05
68262-82629.7139.75
45min19457-945711.11811.2112.0611.2011.3012.01
29527-952711.20011.28
310389-1038912.21312.31
410448-1044812.28312.37
57350-73508.6418.72
610052-1005211.81711.91
60min110318-1031812.13012.907.5612.2713.047.56
210218-1021812.01212.15
312120-1212014.24814.41
411600-1160013.63713.79
510215-1021512.00912.14
611359-1135913.35413.51
90min112949-1294915.22315.034.7315.4315.254.75
211915-1191514.00714.21
312861-1286115.11915.36
413097-1309715.39715.63
512286-1228614.44314.64
613615-1361516.00616.24
120min113363-1336315.70916.255.7016.0116.555.70
212721-1272114.95515.24
314753-1475317.34417.67
414300-1430016.81117.13
513354-1335415.69915.98
614422-1442216.95417.27
极限114237-1423716.73717.227.9517.1217.627.89
212827-1282715.07915.45
315952-1595218.75319.18
415845-1584518.62719.04
514278-1427816.78517.15
614774-1477417.36817.78
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