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101278-202104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500
标示量(mg)20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%
110.153901011389722938997083898711389821438989750.04
210.193944172394563039449010.03
单位质量响应值RSD%判断
384135.47387134.540.55数据可信
供试品溶液-2024091313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%
5min1833803-83380319.46021.7717.3919.4621.7717.38
2966926-96692622.56722.57
3958575-95857522.37222.37
41020389-102038923.81423.81
5672613-67261315.69815.70
61143735-114373526.69326.69
10min12169896-216989650.64250.249.2950.6950.299.29
22306791-230679153.83753.89
32083530-208353048.62648.68
42255132-225513252.63152.68
51786590-178659041.69641.73
62314927-231492754.02754.09
15min12795643-279564365.24665.755.9165.4065.915.92
22972182-297218269.36669.54
32804991-280499165.46465.62
42861926-286192666.79366.96
52513251-251325158.65558.78
62956232-295623268.99469.17
20min13146514-314651473.43574.093.0973.7474.403.11
23251992-325199275.89776.22
33188965-318896574.42674.73
43203320-320332074.76175.08
52994787-299478769.89470.15
63262694-326269476.14676.48
30min13516156-351615682.06282.281.6082.5382.751.62
23537686-353768682.56483.06
33543284-354328482.69583.16
43569152-356915283.29983.78
53418776-341877679.78980.20
63568907-356890783.29383.79
45min13779088-377908888.19888.241.2188.8488.891.24
23778823-377882388.19288.87
33791576-379157688.49089.14
43820925-382092589.17589.84
53695603-369560386.25086.84
63819129-381912989.13389.82
60min13930221-393022191.72591.531.2292.5792.381.24
23908139-390813991.21092.08
33953535-395353592.27093.12
43955893-395589392.32593.19
53832450-383245089.44490.23
63951648-395164892.22593.11
极限14060424-406042494.76494.171.1995.8195.231.21
24013155-401315593.66194.74
34056484-405648494.67295.73
44066083-406608394.89695.97
53946651-394665192.10993.09
64067695-406769594.93496.02
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101278-202104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500
标示量(mg)20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%
110.153912545390783639079543908239390523539083620.07
210.193999907400242440011660.05
单位质量响应值RSD%判断
385060.30392656.131.39数据可信
供试品溶液-2024091313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%
5min11015369-101536923.50322.1412.3423.5022.1412.33
2721428-72142816.69916.70
31003607-100360723.23023.23
41004160-100416023.24323.24
5958868-95886822.19522.19
61036502-103650223.99223.99
10min12141506-214150649.56950.575.6649.6250.625.66
21956831-195683145.29545.33
32225058-222505851.50351.55
42303462-230346253.31853.37
52227320-222732051.55651.60
62254586-225458652.18752.24
15min12861253-286125366.22966.242.7866.3966.402.79
22720597-272059762.97363.11
32873312-287331266.50866.67
42967831-296783168.69668.87
52872301-287230166.48566.65
62874925-287492566.54666.71
20min13192719-319271973.90273.921.1174.2174.221.12
23150134-315013472.91673.19
33187851-318785173.78974.10
43257824-325782475.40875.73
53183278-318327873.68373.99
63188069-318806973.79474.11
30min13514689-351468981.35481.460.5881.8381.940.58
23524271-352427181.57682.02
33511779-351177981.28781.76
43556246-355624682.31682.81
53496810-349681080.94081.42
63511913-351191381.29081.77
45min13752230-375223086.85286.890.4487.5187.550.44
23767950-376795087.21687.84
33751225-375122586.82987.49
43776768-377676887.42088.09
53730408-373040886.34787.00
63745819-374581986.70487.37
60min13880986-388098689.83389.910.3890.6890.750.37
23900221-390022190.27891.09
33886051-388605189.95090.80
43900922-390092290.29491.16
53865006-386500689.46390.31
63871572-387157289.61590.47
极限13991057-399105792.38192.320.3193.4393.360.31
23996798-399679892.51393.53
33999372-399937292.57393.62
43994293-399429392.45593.52
53966569-396656991.81492.86
63982097-398209792.17393.23
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