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101278-202003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%
19.533554758354174935671703571905356482335600810.34
29.643622757360956936161630.26
单位质量响应值RSD%判断
373565.69375120.640.30数据可信
供试品溶液-2024112621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%
5min11124484-112448427.03520.6129.8327.0420.6229.83
2467553-46755311.24111.24
3781776-78177618.79618.80
41078979-107897925.94125.94
5690021-69002116.59016.59
61001802-100180224.08624.09
10min12024011-202401148.66249.069.5848.7249.109.59
22003518-200351848.16948.19
31749022-174902242.05042.09
42270789-227078954.59554.65
51948056-194805646.83646.87
62247173-224717354.02754.08
15min12526986-252698660.75462.995.2260.9263.155.24
22553812-255381261.39961.53
32482635-248263559.68859.82
42830090-283009068.04268.22
52581354-258135462.06162.20
62746218-274621866.02566.20
20min12855592-285559268.65570.242.3568.9670.542.37
22879778-287977869.23669.50
32869159-286915968.98169.25
43017553-301755372.54972.88
52912716-291271670.02870.31
62994611-299461171.99772.32
30min13261185-326118578.40678.581.1978.8679.031.21
23220582-322058277.43077.85
33234077-323407777.75478.18
43284621-328462178.97079.46
53282025-328202578.90779.34
63327578-332757880.00280.48
45min13503745-350374584.23884.180.9584.8784.800.96
23463332-346333283.26683.86
33476486-347648683.58284.18
43537965-353796585.06185.73
53542671-354267185.17485.78
63482661-348266183.73184.39
60min13610026-361002686.79387.141.0287.6187.961.02
23569334-356933485.81586.59
33637120-363712087.44488.22
43651940-365194087.80188.66
53672472-367247288.29489.09
63606921-360692186.71887.56
极限13727087-372708789.60789.560.8490.6290.560.84
23683823-368382388.56789.54
33722194-372219489.49090.46
43748069-374806990.11291.16
53769516-376951690.62891.62
63699708-369970888.94989.99
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101278-202003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%
19.533592346358958335936473592236358812335911870.07
29.643641415363340936374120.16
单位质量响应值RSD%判断
376829.70377324.900.10数据可信
供试品溶液-2024112621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%
5min1998388-99838823.82922.538.8223.8322.538.83
2950506-95050622.68622.69
3838322-83832220.00920.01
4867447-86744720.70420.70
51064918-106491825.41725.42
6943411-94341122.51722.52
10min12111922-211192250.40750.857.9350.4650.907.93
22144816-214481651.19251.24
31866986-186698644.56144.61
42049929-204992948.92748.97
52355643-235564356.22456.28
62254341-225434153.80653.86
15min12633574-263357462.85864.183.5263.0264.343.53
22700269-270026964.44964.61
32566397-256639761.25461.40
42638208-263820862.96863.12
52806441-280644166.98467.16
62789777-278977766.58666.76
20min12941554-294155470.20871.222.0770.5171.522.08
22996427-299642771.51871.83
32908972-290897269.43169.71
42949709-294970970.40370.70
53035971-303597172.46272.79
63070217-307021773.27973.60
30min13269358-326935878.03278.351.3178.4978.821.32
23284943-328494378.40478.87
33238266-323826677.29077.72
43243990-324399077.42777.88
53308506-330850678.96779.46
63351942-335194280.00380.48
45min13483340-348334083.14083.761.3783.7784.401.37
23505092-350509283.65984.30
33490149-349014983.30283.91
43504328-350432883.64184.26
53470210-347021082.82683.49
63603847-360384786.01686.67
60min13621164-362116486.42986.910.9787.2587.740.97
23616117-361611786.30987.14
33617631-361763186.34587.14
43650876-365087687.13887.95
53635322-363532286.76787.62
63707623-370762388.49389.34
极限13701602-370160288.34989.011.0289.3690.021.03
23734611-373461189.13790.16
33699032-369903288.28889.27
43720911-372091188.81089.81
53717302-371730288.72489.77
63801510-380151090.73491.78
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101278-202003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%
19.533573902359350136078043596772359685535937670.35
29.643592120359519135936560.07
单位质量响应值RSD%判断
377100.42372785.890.82数据可信
供试品溶液-2024112721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%
5min1908392-90839221.80526.4316.9121.8126.4316.90
21019733-101973324.47824.48
31082369-108236925.98225.98
4941885-94188522.60922.61
51299009-129900931.18231.18
61355152-135515232.53032.53
10min11986645-198664547.68853.417.1147.7453.477.12
22166262-216626252.00052.05
32210760-221076053.06853.13
42182497-218249752.39052.44
52393739-239373957.46057.53
62410292-241029257.85857.93
15min12506284-250628460.16264.974.0660.3265.144.07
22745940-274594065.91566.08
32693030-269303064.64564.82
42692882-269288264.64164.81
52784200-278420066.83367.03
62816555-281655567.61067.81
20min12917357-291735770.03071.881.7270.3272.201.73
23027508-302750872.67472.99
32958416-295841671.01571.33
43009396-300939672.23972.55
52992486-299248671.83372.18
63062335-306233573.51073.86
30min13247718-324771877.96078.831.2378.4079.311.24
23332339-333233979.99180.47
33244827-324482777.89078.37
43309884-330988479.45279.92
53250403-325040378.02478.53
63317980-331798079.64680.16
45min13470564-347056483.30983.941.2183.9384.601.20
23566274-356627485.60686.26
33473095-347309583.37084.02
43522862-352286284.56485.21
53450559-345055982.82983.51
63498406-349840683.97784.67
60min13621055-362105586.92186.931.2987.7287.771.28
23687579-368757988.51889.36
33581538-358153885.97386.81
43652814-365281487.68488.52
53558992-355899285.43286.29
63625604-362560487.03187.91
极限13709316-370931689.04089.261.0990.0490.301.08
23783936-378393690.83191.87
33676451-367645188.25189.28
43740105-374010589.77990.81
53678703-367870388.30589.36
63721946-372194689.34390.41
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101278-202003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%
19.533599996359931236045933619950361272536073150.25
29.643654526365567636551010.03
单位质量响应值RSD%判断
378522.04379159.850.12数据可信
供试品溶液-2024112721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%
5min1837964-83796419.90724.1414.3419.9124.1414.33
21050000-105000024.94524.94
3844240-84424020.05620.06
41086824-108682425.81925.82
51203949-120394928.60228.60
61074207-107420725.52025.52
10min12150294-215029451.08451.123.8351.1351.173.83
22250698-225069853.46953.52
32035424-203542448.35548.40
42229713-222971352.97153.03
52085605-208560549.54749.61
62157969-215796951.26651.32
15min12682883-268288363.73664.152.6163.8964.312.61
22753590-275359065.41665.59
32637723-263772362.66462.82
42786418-278641866.19666.37
52604921-260492161.88462.06
62735075-273507564.97665.15
20min12966160-296616070.46671.301.8570.7771.611.85
23058342-305834272.65672.98
32923643-292364369.45669.75
43058393-305839372.65772.98
52973044-297304470.63070.94
63027342-302734271.92072.23
30min13267107-326710777.61678.301.3478.0778.771.35
23346936-334693679.51279.99
33232727-323272776.79977.24
43336254-333625479.25879.74
53279674-327967477.91478.38
63313356-331335678.71479.19
45min13469715-346971582.42983.811.5283.0684.451.53
23583336-358333685.12885.79
33462532-346253282.25882.87
43568406-356840684.77485.43
53513310-351331083.46584.11
63569290-356929084.79585.44
60min13596660-359666085.44586.961.4586.2687.791.46
23714807-371480788.25289.10
33597944-359794485.47586.27
43693783-369378387.75288.60
53654968-365496886.83087.66
63704135-370413587.99888.84
极限13706932-370693288.06489.431.5689.0790.461.57
23833589-383358991.07392.12
33689217-368921787.64488.63
43811066-381106690.53891.58
53750049-375004989.08990.11
63796433-379643390.19191.22
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