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101278-202405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%
110.173923119392264939223333917920392319239218430.06
210.063916729392256239196460.11
单位质量响应值RSD%判断
385628.61389626.840.73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%
5min12943668-294366868.28053.7723.5368.2853.7723.53
22422721-242272156.19656.20
32665834-266583461.83561.84
41452657-145265733.69533.70
51901349-190134944.10344.10
62522043-252204358.50058.50
10min13794976-379497688.02784.863.6988.1884.983.71
23732080-373208086.56886.69
33756775-375677587.14087.28
43442689-344268979.85579.93
53556977-355697782.50682.60
63666455-366645585.04585.18
15min14021002-402100293.26991.621.0393.6291.931.06
23923101-392310190.99891.32
33969006-396900692.06392.39
43917286-391728690.86491.12
53917630-391763090.87291.15
63951252-395125291.65191.97
20min14115508-411550895.46194.001.3696.0294.511.36
24056534-405653494.09494.61
34088197-408819794.82895.36
44068440-406844094.37094.82
54028709-402870993.44893.93
63957978-395797891.80792.33
30min14186629-418662997.11196.421.0397.8897.141.04
24195085-419508597.30798.04
34191098-419109897.21597.96
44146847-414684796.18896.85
54133226-413322695.87296.56
64087231-408723194.80695.53
45min14221875-422187597.92996.591.1398.9197.531.14
24136668-413666895.95296.90
34208075-420807597.60998.57
44178448-417844896.92197.80
54098776-409877695.07395.98
64141888-414188896.07397.01
60min14213930-421393097.74496.910.8398.9498.060.86
24198255-419825597.38198.54
34211590-421159097.69098.87
44164591-416459196.60097.69
54137649-413764995.97597.09
64140920-414092096.05197.20
极限14193539-419353997.27196.581.0198.6997.941.02
24194335-419433597.29098.66
34204963-420496397.53698.93
44160160-416016096.49797.80
54126312-412631295.71297.04
64102262-410226295.15496.52
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101278-202405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%
110.173952506394208939479883939933394052539446080.14
210.063920437391408739172620.12
单位质量响应值RSD%判断
387867.06389389.860.28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%
5min12705757-270575762.59853.8717.0562.6053.8717.05
22237007-223700751.75451.75
32566084-256608459.36759.37
41644703-164470338.05138.05
52632885-263288560.91360.91
62185115-218511550.55350.55
10min13596120-359612083.19783.010.5083.3483.120.53
23581885-358188582.86882.98
33602453-360245383.34483.48
43555130-355513082.24982.33
53601662-360166283.32683.46
63589693-358969383.04983.16
15min13879472-387947289.75389.760.4690.0890.060.45
23876751-387675189.69089.99
33892081-389208190.04490.36
43879456-387945689.75290.02
53849089-384908989.05089.37
63900674-390067490.24390.54
20min14008861-400886192.74692.451.3493.2792.951.33
23996525-399652592.46192.96
34016377-401637792.92093.44
44021201-402120193.03293.50
53891246-389124690.02590.54
64041345-404134593.49894.00
30min14113829-411382995.17595.240.8195.9095.940.80
24109434-410943495.07395.78
34134304-413430495.64896.37
44104116-410411694.95095.62
54068791-406879194.13394.85
64168299-416829996.43597.14
45min14157946-415794696.19596.210.7297.1497.130.71
24152805-415280596.07696.99
34160460-416046096.25397.19
44159348-415934896.22897.11
54113470-411347095.16696.09
64206587-420658797.32198.24
60min14150845-415084596.03196.130.8197.1997.270.80
24160082-416008296.24597.37
34165468-416546896.36997.52
44167733-416773396.42297.52
54093376-409337694.70195.84
64194042-419404297.03098.17
极限14141292-414129295.81095.910.8097.1897.260.78
24158673-415867396.21297.55
34155491-415549196.13997.50
44154256-415425696.11097.42
54083684-408368494.47795.83
64180309-418030996.71398.06
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