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N877-220209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%
110.562047649204751220483302047227204555220472540.06
210.602060450206114820607990.03
单位质量响应值RSD%判断
193868.75194415.000.20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%
5min17256-72560.3360.3611.180.340.3611.07
26896-68960.3190.32
37132-71320.3300.33
48333-83330.3860.39
58466-84660.3920.39
69038-90380.4190.42
10min125366-253661.1751.206.271.181.206.44
224997-249971.1581.16
324472-244721.1331.13
424909-249091.1541.15
527112-271121.2561.26
628645-286451.3271.33
15min136132-361321.6731.665.241.681.665.41
236251-362511.6791.68
336155-361551.6741.68
432854-328541.5221.52
534797-347971.6121.61
638551-385511.7851.79
20min138656-386561.7901.824.791.801.824.75
240554-405541.8781.88
340391-403911.8711.88
436640-366401.6971.70
537909-379091.7561.76
641644-416441.9291.93
30min142983-429831.9911.925.252.001.935.37
243166-431661.9992.01
342282-422821.9581.97
437918-379181.7561.76
539553-395531.8321.84
642710-427101.9781.99
45min145213-452132.0941.996.722.112.006.68
245016-450162.0852.10
344040-440402.0402.05
438627-386271.7891.80
539816-398161.8441.86
644475-444752.0602.07
60min145898-458982.1261.986.992.141.996.92
244791-447912.0742.09
344569-445692.0642.08
439195-391951.8151.83
538955-389551.8041.82
642925-429251.9882.00
90min144293-442932.0511.968.052.071.978.14
246644-466442.1602.18
341780-417801.9351.95
436880-368801.7081.72
540295-402951.8661.88
643407-434072.0102.03
120min145926-459262.1271.987.632.152.007.61
245625-456252.1132.14
343778-437782.0272.05
438208-382081.7691.79
539235-392351.8171.84
643499-434992.0152.04
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143832-438322.0301.945.762.061.965.76
242371-423711.9621.99
344301-443012.0522.08
438559-385591.7861.81
539175-391751.8141.84
642682-426821.9772.00
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N877-220209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%
110.562059288205926720576132056701205741520580570.06
210.602059715206330920615120.13
单位质量响应值RSD%判断
194891.76194482.260.15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%
5min19619-96190.4440.5323.590.440.5323.99
26984-69840.3230.32
311766-117660.5430.54
413995-139950.6460.65
513663-136630.6310.63
612866-128660.5940.59
10min127268-272681.2591.298.241.261.308.25
224838-248381.1471.15
326127-261271.2071.21
430625-306251.4141.42
530030-300301.3871.39
629268-292681.3521.35
15min135579-355791.6431.666.161.651.666.10
234242-342421.5811.58
332628-326281.5071.51
437222-372221.7191.72
538772-387721.7911.79
636795-367951.6991.70
20min140322-403221.8621.815.391.871.825.33
239480-394801.8231.83
335130-351301.6221.63
441007-410071.8941.90
540228-402281.8581.86
639057-390571.8041.81
30min142277-422771.9521.924.741.961.924.67
241576-415761.9201.93
337639-376391.7381.75
442026-420261.9411.95
543265-432651.9982.01
642074-420741.9431.95
45min141970-419701.9381.966.541.951.976.52
244285-442852.0452.06
337351-373511.7251.74
444725-447252.0652.08
544263-442632.0442.06
641828-418281.9321.94
60min142937-429371.9831.975.082.001.985.08
242993-429931.9852.00
338280-382801.7681.78
443889-438892.0272.04
543689-436892.0182.03
643874-438742.0262.04
90min141489-414891.9161.955.891.931.975.95
243908-439082.0282.05
337610-376101.7371.75
443151-431511.9932.01
544502-445022.0552.07
642596-425961.9671.99
120min139244-392441.8121.907.131.831.927.14
242730-427301.9731.99
341103-411031.8981.92
443049-430491.9882.01
544082-440822.0362.06
636199-361991.6721.69
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140174-401741.8551.935.211.881.955.20
241906-419061.9351.96
338214-382141.7651.79
442623-426231.9681.99
544147-441472.0392.07
643193-431931.9952.02
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