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%
110.043864038386143138671883873782386514938663180.13
210.173925062392800539265340.06
单位质量响应值RSD%判断
385091.43386089.870.19数据可信
供试品溶液-2024112521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%
5min11359463-135946331.73138.8716.8231.7338.8616.82
21257619-125761929.35429.35
31827548-182754842.65742.66
41816763-181676342.40542.40
51823407-182340742.56042.56
61906097-190609744.49044.49
10min13212316-321231674.97878.237.4675.0578.327.47
22921008-292100868.17968.24
33394632-339463279.23479.33
43456779-345677980.68480.78
53614912-361491284.37584.47
63511273-351127381.95682.05
15min13811797-381179788.97189.791.9689.2190.051.98
23781051-378105188.25388.47
33886535-388653590.71590.99
43758646-375864687.73088.00
53954620-395462092.30492.59
63889434-388943490.78391.06
20min14008946-400894693.57293.760.7194.0194.220.73
23973255-397325592.73993.15
34006893-400689393.52494.00
44046960-404696094.46094.93
54049119-404911994.51095.00
64016613-401661393.75194.23
30min14123074-412307496.23696.170.4496.8896.840.46
24092179-409217995.51596.13
34112905-411290595.99996.68
44142788-414278896.69697.37
54135674-413567496.53097.23
64115497-411549796.05996.75
45min14186757-418675797.72297.530.3998.5898.410.40
24157311-415731197.03597.87
34165203-416520397.21998.11
44197307-419730797.96998.86
54192078-419207897.84798.76
64172506-417250697.39098.29
60min14185738-418573897.69997.750.5498.7798.850.56
24153137-415313796.93897.98
34173204-417320497.40698.52
44211752-421175298.30699.42
54208813-420881398.23799.37
64194506-419450697.90399.02
极限14198615-419861597.99997.830.5099.2999.150.51
24166301-416630197.24598.51
34166582-416658297.25298.58
44216963-421696398.42899.76
54204708-420470898.14199.49
64195754-419575497.93299.27
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%
110.043869725386338738753333872301387864538718780.15
210.173957743395433939560410.07
单位质量响应值RSD%判断
385645.22388991.250.62数据可信
供试品溶液-2024112621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%
5min11750760-175076040.68339.232.3740.6839.232.37
21694185-169418539.36839.37
31646449-164644938.25938.26
41647708-164770838.28838.29
51711543-171154339.77139.77
61678095-167809538.99438.99
10min13173602-317360273.74573.423.6773.8473.513.67
23330781-333078177.39877.49
33005713-300571369.84469.93
43243970-324397075.38175.47
53096372-309637271.95172.04
63106415-310641572.18472.27
15min13768375-376837587.56688.020.9887.8288.260.99
23837458-383745889.17289.43
33738056-373805686.86287.10
43769186-376918687.58587.84
53822536-382253688.82589.07
63790470-379047088.08088.33
20min14027211-402721193.58193.080.8494.0393.530.85
24044473-404447393.98294.44
33972875-397287592.31892.75
43967625-396762592.19692.64
54034604-403460493.75394.20
63988437-398843792.68093.12
30min14167613-416761396.84396.260.8997.5096.910.89
24172876-417287696.96697.63
34107653-410765395.45096.09
44103012-410301295.34295.99
54185907-418590797.26997.92
64118461-411846195.70196.35
45min14237062-423706298.45797.900.8799.3398.760.87
24238582-423858298.49399.37
34179687-417968797.12497.97
44163750-416375096.75497.62
54255752-425575298.89299.76
64202404-420240497.65298.51
60min14248103-424810398.71498.210.8099.8099.290.80
24257042-425704298.921100.02
34200977-420097797.61998.69
44184339-418433997.23298.31
54262729-426272999.054100.14
64204353-420435397.69798.78
极限14281251-428125199.48498.631.00100.7999.941.00
24284520-428452099.560100.88
34209771-420977197.82399.11
44196191-419619197.50798.80
54282264-428226499.508100.82
64213896-421389697.91999.21
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%
110.043908639390955939053493903184389402939041520.16
210.173962631396729239649620.09
单位质量响应值RSD%判断
388859.76389868.440.19数据可信
供试品溶液-2024112721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%
5min11695497-169549739.19139.149.9139.1939.149.91
21846878-184687842.69042.69
31738504-173850440.18540.18
41372419-137241931.72331.72
51704813-170481339.40639.41
61801945-180194541.65141.65
10min13376698-337669878.05173.758.4878.1473.848.47
23497545-349754580.84580.94
32888101-288810166.75766.85
42834045-283404565.50865.58
53318598-331859876.70876.80
63228283-322828374.62174.71
15min13848155-384815588.94987.514.2789.2187.764.28
23965849-396584991.66991.94
33664722-366472284.70984.95
43524054-352405481.45781.67
53875613-387561389.58389.84
63835988-383598888.66888.93
20min14031900-403190093.19692.742.0893.6593.192.09
24138506-413850695.66096.14
33903652-390365290.23290.66
43938602-393860291.03991.44
54044931-404493193.49793.95
64016328-401632892.83693.29
30min14141350-414135095.72695.971.6296.3996.621.63
24259975-425997598.46899.16
34057001-405700193.77694.40
44151750-415175095.96696.57
54178362-417836296.58197.25
64121826-412182695.27595.94
45min14196990-419699097.01297.521.6897.8998.391.69
24326057-432605799.995100.90
34110635-411063595.01695.85
44226958-422695897.70598.52
54251477-425147798.27199.15
64202431-420243197.13898.01
60min14225802-422580297.67898.031.6498.7799.111.65
24342693-4342693100.380101.51
34134799-413479995.57496.62
44258426-425842698.43299.46
54272679-427267998.76199.86
64211124-421112497.33998.43
极限14232911-423291197.84298.221.7699.1599.521.77
24352920-4352920100.616101.97
34127455-412745595.40596.66
44275685-427568598.831100.08
54279214-427921498.913100.23
64228284-422828497.73599.04
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