氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.011821491821201819441821421819181820550.07
214.091821991817551819770.18
单位质量响应值RSD%判断
12994.6512915.330.44数据可信
供试品溶液-2733947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%
2min112043-120436.6085.6730.486.615.6730.49
214863-148638.1568.16
311495-114956.3086.31
49361-93615.1375.14
55885-58853.2293.23
68329-83294.5704.57
5min151147-5114728.06526.6122.3728.0826.6222.38
267092-6709236.81536.83
352699-5269928.91728.93
439526-3952621.68921.70
539760-3976021.81721.82
640707-4070722.33722.34
10min186099-8609947.24444.1411.0147.3044.2011.00
283549-8354945.84545.92
377784-7778442.68242.74
470474-7047438.67138.72
571517-7151739.24339.28
693247-9324751.16751.21
15min1100150-10015054.95551.279.6155.0951.409.60
294205-9420551.69251.84
389079-8907948.88049.01
480674-8067444.26844.38
590231-9023149.51249.62
6106263-10626358.30958.44
20min1106797-10679758.60255.458.7158.8355.668.71
2102261-10226156.11356.35
395159-9515952.21652.43
489951-8995149.35849.54
597547-9754753.52653.72
6114557-11455762.86063.09
30min1117327-11732764.38062.165.7364.7162.465.72
2107817-10781759.16259.49
3105207-10520757.72958.03
4110621-11062160.70060.97
5116305-11630563.81964.10
6122365-12236567.14467.48
45min1134236-13423673.65871.704.4074.0972.114.40
2127448-12744869.93470.36
3122960-12296067.47167.87
4126588-12658869.46269.83
5135687-13568774.45474.84
6137051-13705175.20375.65
60min1148534-14853481.50478.693.3682.0679.223.36
2140433-14043377.05977.60
3137532-13753275.46775.97
4139630-13963076.61877.10
5148519-14851981.49682.00
6145818-14581880.01480.58
90min1153548-15354884.25583.301.2984.9583.971.29
2150499-15049982.58283.26
3152017-15201783.41584.05
4149121-14912181.82682.44
5154418-15441884.73385.38
6151291-15129183.01783.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1156144-15614485.68085.331.0986.5186.121.11
2154339-15433984.68985.50
3154814-15481484.95085.72
4153261-15326184.09884.84
5157971-15797186.68287.47
6156487-15648785.86886.71
极限1154614-15461484.84086.072.3185.8287.012.28
2150563-15056382.61783.57
3160257-16025787.93788.85
4158180-15818086.79787.68
5158213-15821386.81587.75
6159264-15926487.39288.38
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