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430038-202402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%
110.654231894423014842183604205819419152842155500.41
210.774187592418796341877780.01
单位质量响应值RSD%判断
395826.29388837.331.26数据可信
供试品溶液-250603批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1899170-89917020.60819.3022.8120.6119.3022.80
2476722-47672210.92610.93
3838550-83855019.21819.22
4864081-86408119.80419.80
51037165-103716523.77023.77
6937787-93778721.49321.49
10min12206194-220619450.56344.7822.7750.6144.8222.77
21140365-114036526.13626.16
32096452-209645248.04848.09
41761567-176156740.37340.42
52159283-215928349.48849.54
62358962-235896254.06454.11
15min13049561-304956169.89264.4012.6770.0564.5412.70
22131386-213138648.84848.93
32936672-293667267.30567.45
42705271-270527162.00162.13
52985723-298572368.42968.59
63050456-305045669.91270.08
20min13341187-334118776.57573.225.9476.8973.505.98
22838133-283813365.04665.24
33275471-327547175.06975.37
43126125-312612571.64771.92
53288097-328809775.35975.67
63299376-329937675.61775.94
30min13635115-363511583.31281.312.0983.8081.762.15
23416264-341626478.29678.63
33535497-353549781.02981.49
43537954-353795481.08581.52
53585431-358543182.17382.66
63576042-357604281.95882.45
45min13834311-383431187.87786.101.4088.5586.741.45
23682551-368255184.39984.91
33753528-375352886.02686.67
43720630-372063085.27285.88
53786006-378600686.77087.44
63764720-376472086.28286.96
60min13933013-393301390.13988.791.0391.0089.611.08
23829493-382949387.76788.46
33881569-388156988.96089.80
43829432-382943287.76588.57
53893929-389392989.24490.10
63876384-387638488.84189.71
极限14002262-400226291.72690.780.9192.7991.800.95
23920072-392007289.84390.73
33958852-395885290.73291.77
43929054-392905490.04991.04
54004369-400436991.77592.83
63950836-395083690.54891.61
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430038-202402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%
110.654170961417471441768214176720417500041748430.06
210.774152260414978141510200.05
单位质量响应值RSD%判断
392004.04385424.331.20数据可信
供试品溶液-250603批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11035147-103514723.94519.8720.3923.9419.8720.38
2874799-87479920.23620.24
3904599-90459920.92520.92
4970492-97049222.44922.45
5837665-83766519.37719.38
6531756-53175612.30012.30
10min12167566-216756650.14046.1813.7050.1946.2213.71
21760284-176028440.71840.76
32215246-221524651.24351.29
42182095-218209550.47650.53
52099324-209932448.56148.60
61553831-155383135.94335.97
15min12988549-298854969.13066.657.2069.3066.807.21
22685776-268577662.12762.26
33075191-307519171.13571.29
43031528-303152870.12570.29
52944380-294438068.10968.26
62563502-256350259.29859.41
20min13301870-330187076.37875.272.8876.7075.572.91
23156082-315608273.00673.28
33354005-335400577.58477.90
43315414-331541476.69177.01
53275830-327583075.77676.08
63121146-312114672.19872.44
30min13583250-358325082.88782.371.7383.3782.831.77
23495301-349530180.85281.29
33643294-364329484.27684.77
43607775-360777583.45483.94
53543780-354378081.97482.44
63491023-349102380.75481.15
45min13786687-378668787.59387.231.2488.2687.881.27
23718977-371897786.02686.64
33836677-383667788.74989.43
43804836-380483688.01388.69
53754792-375479286.85587.51
63724173-372417386.14786.73
60min13896953-389695390.14389.971.1291.0190.811.15
23839671-383967188.81889.62
33953642-395364291.45592.33
43918079-391807990.63291.50
53880555-388055589.76490.61
63847355-384735588.99689.77
极限13999567-399956792.51791.941.0793.5892.981.10
23930888-393088890.92891.93
34027051-402705193.15394.23
44005542-400554292.65593.73
53961335-396133591.63392.68
63924077-392407790.77191.74
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