非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.033903872390637739053543904253390272239045160.04
210.123912654392270739176800.19
单位质量响应值RSD%判断
389283.75387122.530.40数据可信
供试品溶液-20250401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%
5min11335467-133546730.96129.3125.2730.9629.3025.28
21679445-167944538.93638.94
31165292-116529227.01627.02
41006389-100638923.33223.33
51550714-155071435.95235.95
6846879-84687919.63419.63
10min13280955-328095576.06572.2212.2576.1272.2712.26
23504644-350464481.25181.32
33167094-316709473.42673.47
42884908-288490866.88366.92
53385968-338596878.50078.56
62467670-246767057.21057.24
15min13777839-377783987.58585.225.1487.7685.395.16
23846230-384623089.17189.37
33769586-376958687.39487.56
43563741-356374182.62182.77
53755570-375557087.06987.26
63342481-334248177.49277.62
20min13934535-393453591.21889.982.6291.5490.292.65
23985272-398527292.39492.74
33934885-393488591.22691.54
43836583-383658388.94789.24
53895663-389566390.31790.65
63700164-370016485.78486.04
30min14105756-410575695.18894.791.2195.6695.261.24
24145072-414507296.09996.60
34106067-410606795.19595.66
44080960-408096094.61395.05
54097352-409735294.99395.48
63997454-399745492.67793.08
45min14169059-416905996.65595.990.8697.2996.610.88
24176001-417600196.81697.48
34148698-414869896.18396.81
44152977-415297796.28296.88
54107775-410777595.23495.88
64086659-408665994.74595.30
60min14162199-416219996.49696.620.7797.2997.400.79
24208402-420840297.56798.39
34180742-418074296.92697.71
44190997-419099797.16497.92
54139368-413936895.96796.77
64123877-412387795.60896.32
极限14187977-418797797.09497.240.6598.0598.180.67
24236748-423674898.22499.21
34200435-420043597.38398.33
44209576-420957697.59498.51
54167270-416727096.61497.58
64164851-416485196.55897.43
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.033926499393408939314803927527392260139284390.12
210.123962547396836439654560.11
单位质量响应值RSD%判断
391668.89391843.480.04数据可信
供试品溶液-20250401批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1986046-98604622.65325.489.5322.6525.489.55
21165122-116512226.76726.77
31125398-112539825.85425.85
4990781-99078122.76222.76
51260819-126081928.96528.97
61126376-112637625.87725.88
10min12271354-227135452.18154.222.1852.2254.262.18
22404517-240451755.24055.28
32391878-239187854.95054.99
42337793-233779353.70753.75
52402590-240259055.19655.24
62353017-235301754.05754.10
15min12737584-273758462.89264.461.4263.0264.591.42
22840739-284073965.26265.40
32841501-284150165.27965.41
42795456-279545664.22164.35
52827341-282734164.95465.09
62791592-279159264.13364.27
20min12981035-298103568.48569.381.2668.7169.621.26
22972705-297270568.29368.54
33067240-306724070.46570.71
43024674-302467469.48769.72
53053821-305382170.15770.41
63021103-302110369.40569.65
30min13246403-324640374.58175.760.9574.9276.110.96
23313777-331377776.12976.49
33331693-333169376.54176.90
43285420-328542075.47875.83
53321567-332156776.30876.67
63286629-328662975.50575.86
45min13461466-346146679.52280.860.9179.9981.340.92
23532033-353203381.14381.63
33553626-355362681.63982.13
43525467-352546780.99281.47
53536387-353638781.24381.74
63508807-350880780.60981.09
60min13593190-359319082.54883.481.0083.1584.101.01
23659690-365969084.07684.70
33679078-367907884.52185.15
43603059-360305982.77583.39
53658703-365870384.05384.68
63608840-360884082.90883.52
极限13694214-369421484.86986.251.0185.6187.001.02
23782736-378273686.90387.66
33796197-379619787.21287.98
43738262-373826285.88186.63
53775529-377552986.73787.51
63737767-373776785.86986.62
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