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%
110.043887331388657438863183883989387814038844700.10
210.173950478393917939448280.21
单位质量响应值RSD%判断
386899.40387888.690.19数据可信
供试品溶液-2024112521批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12729879-272987963.42152.6914.8463.4252.6914.83
22540602-254060259.02459.02
32279217-227921752.95152.95
42268573-226857352.70452.70
51907922-190792244.32544.33
61882899-188289943.74443.74
10min14046969-404696994.02094.172.2194.1694.292.20
24063975-406397594.41594.55
33923111-392311191.14291.26
44090200-409020095.02495.14
54005166-400516693.04993.15
64191464-419146497.37797.47
15min14242481-424248198.56299.481.0898.9199.811.08
24317241-4317241100.299100.64
34320571-4320571100.376100.70
44270249-427024999.20799.54
54216363-421636397.95598.26
64325065-4325065100.481100.79
20min14261421-426142199.00299.960.9699.57100.510.96
24328509-4328509100.561101.12
34346129-4346129100.970101.51
44288943-428894399.642100.19
54251363-425136398.76999.29
64340031-4340031100.828101.37
30min14269315-426931599.186100.030.8999.97100.800.89
24320911-4320911100.384101.17
34345320-4345320100.951101.72
44289802-428980299.662100.43
54260511-426051198.98199.72
64349242-4349242101.042101.80
45min14279148-427914899.414100.140.93100.42101.130.93
24329617-4329617100.587101.60
34362356-4362356101.347102.34
44302457-430245799.956100.95
54253454-425345498.81799.78
64334199-4334199100.693101.68
60min14276858-427685899.361100.061.00100.59101.271.00
24333674-4333674100.681101.91
34346114-4346114100.970102.19
44293681-429368199.752100.97
54242099-424209998.55399.74
64348202-4348202101.018102.23
极限14271551-427155199.238100.350.94100.69101.790.93
24323771-4323771100.451101.91
34360245-4360245101.298102.74
44310083-4310083100.133101.57
54280502-428050299.445100.85
64370317-4370317101.532102.97
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%
110.043922247391232439317573926960391442939215430.21
210.173950860395548439531720.09
单位质量响应值RSD%判断
390591.93388709.140.35数据可信
供试品溶液-2024112621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12579117-257911759.57257.7210.6159.5757.7210.62
22150141-215014149.66349.66
32491475-249147557.54757.55
42678078-267807861.85861.86
52242795-224279551.80451.80
62853368-285336865.90665.91
10min13766687-376668787.00288.728.0687.1388.858.06
23285702-328570275.89276.00
33812962-381296288.07188.20
44046824-404682493.47393.61
53969528-396952891.68791.80
64164581-416458196.19296.34
15min14281143-428114398.88598.123.7199.2198.453.72
23939090-393909090.98491.26
34250797-425079798.18498.51
44328162-432816299.971100.32
54376974-4376974101.098101.42
64312096-431209699.60099.96
20min14293579-429357999.172100.471.2299.72101.011.21
24369429-4369429100.924101.41
34296687-429668799.24499.79
44364127-4364127100.802101.37
54434903-4434903102.436102.98
64338713-4338713100.215100.80
30min14301623-430162399.358100.711.36100.12101.471.34
24412880-4412880101.928102.63
34299237-429923799.303100.07
44380240-4380240101.174101.97
54437754-4437754102.502103.27
64328139-432813999.970100.77
45min14292119-429211999.138100.581.42100.12101.571.40
24395576-4395576101.528102.46
34287883-428788399.040100.02
44380779-4380779101.186102.20
54441887-4441887102.598103.60
64329634-4329634100.005101.03
60min14296314-429631499.235100.511.26100.44101.721.25
24367260-4367260100.874102.03
34301309-430130999.351100.55
44369111-4369111100.917102.16
54442756-4442756102.618103.84
64331584-4331584100.050101.30
极限14289222-428922299.071100.251.35100.50101.691.33
24379363-4379363101.153102.54
34276653-427665398.781100.20
44352075-4352075100.523101.99
54430035-4430035102.324103.78
64314516-431451699.656101.13
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%
110.043916593390952939087633895807389343339048250.26
210.173956178396029039582340.08
单位质量响应值RSD%判断
388926.79389206.880.06数据可信
供试品溶液-2024112721批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12916964-291696467.47653.6218.8667.4853.6218.86
21915549-191554944.31144.31
31830864-183086442.35242.35
42110906-211090648.83048.83
52445643-244564356.57356.57
62689049-268904962.20462.20
10min14147483-414748395.94191.364.1196.0991.484.12
23868755-386875589.49389.59
33863893-386389389.38189.47
43833713-383371388.68388.79
53816724-381672488.29088.42
64166469-416646996.38096.52
15min14197541-419754197.09997.730.8997.4698.060.90
24169913-416991396.46096.76
34231404-423140497.88298.17
44221001-422100197.64197.95
54263172-426317298.61798.94
64266684-426668498.69899.05
20min14200789-420078997.17498.040.9897.7598.580.98
24183655-418365596.77797.29
34240714-424071498.09798.61
44239022-423902298.05898.58
54292583-429258399.29799.84
64271742-427174298.81599.39
30min14197554-419755497.09997.970.9797.8998.720.97
24181925-418192596.73797.46
34245458-424545898.20798.94
44231258-423125897.87998.62
54292127-429212799.287100.05
64262390-426239098.59999.39
45min14192688-419268896.98697.931.0098.0098.911.00
24181073-418107396.71897.66
34235863-423586397.98598.93
44238901-423890198.05599.01
54295101-429510199.355100.34
64258259-425825998.50399.51
60min14187866-418786696.87597.611.1298.1098.801.12
24162470-416247096.28797.44
34197454-419745497.09798.26
44226206-422620697.76298.94
54292339-429233999.292100.49
64250534-425053498.32599.55
极限14178111-417811196.64997.390.9298.0998.800.92
24158738-415873896.20197.57
34217402-421740297.55898.94
44206567-420656797.30798.70
54265439-426543998.669100.09
64234032-423403297.94399.39
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