非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.203958491395399739523033956179395438039550700.06
210.363979692398284439812680.06
单位质量响应值RSD%判断
387751.96384292.280.64数据可信
供试品溶液-4226A批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12100575-210057548.97539.9819.1248.9839.9819.12
21698424-169842439.59939.60
31721006-172100640.12640.13
41894640-189464044.17444.17
51754167-175416740.89940.90
61119726-111972626.10726.11
10min13643367-364336784.94681.345.3885.0581.425.39
23604021-360402184.02884.12
33499607-349960781.59481.68
43576730-357673083.39283.49
53480144-348014481.14081.23
63127182-312718272.91172.97
15min13966641-396664192.48391.682.2392.7891.952.25
24052258-405225894.47994.75
33936420-393642091.77892.05
43936137-393613791.77292.06
53919484-391948491.38491.65
63781978-378197888.17888.40
20min14102518-410251895.65195.591.2996.1596.071.30
24202763-420276397.98898.47
34081490-408149095.16195.64
44077750-407775095.07495.56
54084264-408426495.22595.70
64051785-405178594.46894.88
30min14200809-420080997.94398.491.2398.6699.171.22
24312383-4312383100.544101.25
34188511-418851197.65698.34
44175516-417551697.35398.05
54208640-420864098.12598.81
64259102-425910299.30299.93
45min14248621-424862199.05799.701.3899.99100.601.36
24360807-4360807101.673102.60
34234960-423496098.73999.64
44219348-421934898.37599.29
54254333-425433399.191100.09
64338642-4338642101.156102.00
60min14244087-424408798.95299.641.45100.11100.771.42
24338869-4338869101.162102.31
34220617-422061798.40599.53
44218261-421826198.35099.48
54258445-425844599.286100.41
64361561-4361561101.691102.76
极限14253715-425371599.17699.661.39100.55101.011.37
24353192-4353192101.496102.87
34237688-423768898.803100.14
44207514-420751498.09999.45
54252505-425250599.148100.49
64342889-4342889101.255102.55
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204015023402116940163884016995400879740156740.12
210.364038869403920040390340.01
单位质量响应值RSD%判断
393693.53389868.150.70数据可信
供试品溶液-4226A批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11992880-199288045.78240.1013.5245.7840.1013.52
21715891-171589139.41839.42
31878298-187829843.14943.15
41833168-183316842.11342.11
51743835-174383540.06040.06
61308490-130849030.05930.06
10min13587197-358719782.40780.305.3182.5180.395.32
23608694-360869482.90182.99
33515113-351511380.75180.85
43594189-359418982.56882.66
53544453-354445381.42581.51
63123829-312382971.76271.83
15min13969689-396968991.19490.951.2391.4891.221.23
24052493-405249393.09693.37
33934019-393401990.37590.65
43935103-393510390.39990.68
53920383-392038390.06190.33
63943586-394358690.59490.82
20min14077075-407707593.66194.081.1794.1594.551.17
24191683-419168396.29496.77
34091945-409194594.00394.48
44073823-407382393.58694.06
54068875-406887593.47393.94
64069774-406977493.49393.92
30min14169960-416996095.79596.581.2996.4997.261.29
24310149-431014999.01599.71
34188959-418895996.23196.92
44201936-420193696.52997.22
54161269-416126995.59596.27
64193545-419354596.33796.97
45min14183565-418356596.10797.201.2597.0298.101.24
24331658-433165899.509100.42
34210452-421045296.72597.62
44241331-424133197.43498.33
54214234-421423496.81297.70
64206734-420673496.64097.49
60min14191250-419125096.28497.441.1697.4198.551.16
24331583-433158399.508100.64
34219761-421976196.93998.05
44245172-424517297.52398.64
54248723-424872397.60498.71
64212285-421228596.76797.83
极限14207948-420794896.66797.191.1598.0098.511.14
24320322-432032299.249100.60
34204052-420405296.57897.91
44238965-423896597.38098.71
54182451-418245196.08297.40
64229939-422993997.17398.45
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