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(%)99.9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%
110.652074346207627920764972076699207488320757410.06
210.772071189207804620746180.24
单位质量响应值RSD%判断
194905.26192629.340.84数据可信
供试品溶液-250602批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18174-81740.3790.5019.860.380.5020.04
211112-111120.5160.52
38389-83890.3890.39
413687-136870.6350.64
511076-110760.5140.51
612028-120280.5580.56
10min148678-486782.2591.5025.732.261.5025.79
229278-292781.3591.36
325649-256491.1901.19
430887-308871.4331.43
528060-280601.3021.30
630850-308501.4321.43
15min136203-362031.6801.735.801.681.745.83
238090-380901.7671.77
333986-339861.5771.58
439425-394251.8291.83
536745-367451.7051.71
639709-397091.8431.85
20min139380-393801.8271.884.751.831.894.90
242723-427231.9821.99
337480-374801.7391.74
441385-413851.9201.93
540476-404761.8781.88
642082-420821.9531.96
30min141939-419391.9461.973.361.961.983.33
242891-428911.9902.00
339914-399141.8521.86
443760-437602.0312.04
542976-429761.9942.00
643573-435732.0222.03
45min145209-452092.0982.034.192.112.044.17
245104-451042.0932.11
340207-402071.8661.88
444207-442072.0512.06
544060-440602.0442.06
643765-437652.0312.04
60min145683-456832.1202.043.812.142.063.94
245927-459272.1312.15
341355-413551.9191.93
443462-434622.0172.03
543643-436432.0252.04
644291-442912.0552.07
90min144603-446032.0702.033.972.092.053.96
245608-456082.1162.14
340934-409341.8991.92
442703-427031.9822.00
543609-436092.0242.04
645094-450942.0922.11
120min151194-511942.3762.165.322.402.185.34
245680-456802.1202.14
345508-455082.1122.13
447637-476372.2102.23
544867-448672.0822.10
644733-447332.0762.10
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限144793-447932.0792.072.922.112.102.86
245436-454362.1082.14
345373-453732.1052.13
442019-420191.9501.98
544918-449182.0842.11
645256-452562.1002.13
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