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%
110.421988429198658619854291979786197429919829060.30
210.342001822200293520023780.04
单位质量响应值RSD%判断
190298.08193653.581.24数据可信
长期12月-供试品溶液-2024112422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%
5min11167007-116700754.66052.638.4154.6652.638.41
21085037-108503750.82150.82
31268392-126839259.40859.41
41166519-116651954.63754.64
51031688-103168848.32248.32
61023761-102376147.95147.95
10min11804321-180432184.51082.482.4384.6382.602.43
21778100-177810083.28283.39
31799251-179925184.27384.40
41741441-174144181.56581.69
51690215-169021579.16679.27
61753015-175301582.10782.21
15min12007127-200712794.00991.651.6794.3291.951.68
21974566-197456692.48492.78
31959598-195959891.78392.10
41945767-194576791.13591.44
51910391-191039189.47889.76
61943158-194315891.01391.30
20min12092464-209246498.00695.681.3898.5296.181.38
22049135-204913595.97796.48
32042558-204255895.66996.19
42031929-203192995.17195.68
52007942-200794294.04794.53
62032652-203265295.20595.70
30min12157670-2157670101.06098.521.32101.8099.241.33
22095376-209537698.14298.86
32103641-210364198.52999.27
42090410-209041097.91098.63
52079720-207972097.40998.10
62093684-209368498.06398.77
45min12190524-2190524102.599100.331.29103.56101.271.29
22152069-2152069100.798101.73
32141216-2141216100.289101.24
42124456-212445699.504100.44
52111300-211130098.88899.80
62133264-213326499.917100.84
60min12194874-2194874102.803100.811.13103.99101.971.13
22161558-2161558101.242102.40
32153496-2153496100.865102.04
42130996-213099699.811100.97
52130254-213025499.776100.90
62142616-2142616100.355101.50
极限12206599-2206599103.352101.101.31104.77102.481.31
22173768-2173768101.814103.20
32157161-2157161101.036102.44
42139770-2139770100.222101.60
52128877-212887799.711101.06
62144820-2144820100.458101.82
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%
110.422037431203688120372152034211203344920358370.10
210.341987286198481419860500.09
单位质量响应值RSD%判断
195377.83192074.471.21数据可信
长期12月-供试品溶液-2024112422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%
5min11408098-140809865.35657.1712.1565.3657.1712.16
21297182-129718260.20860.21
31213138-121313856.30756.31
41327738-132773861.62661.63
5982458-98245845.60045.60
61161983-116198353.93353.93
10min11890862-189086287.76384.213.6687.9184.343.67
21852690-185269085.99186.13
31829849-182984984.93185.06
41830338-183033884.95485.09
51699633-169963378.88778.99
61783034-178303482.75882.88
15min12021752-202175293.83892.531.5894.1892.841.60
22003475-200347592.99093.31
32003128-200312892.97493.29
42002551-200255192.94793.27
51931431-193143189.64689.92
61998816-199881692.77493.08
20min12087090-208709096.87196.121.4097.4296.641.42
22069564-206956496.05796.59
32063222-206322295.76396.28
42084187-208418796.73697.27
52019113-201911393.71694.19
62102864-210286497.60398.11
30min12124976-212497698.62998.390.9099.3999.120.92
22122829-212282998.53099.27
32129834-212983498.85599.59
42125479-212547998.65399.40
52081942-208194296.63297.32
62134132-213413299.05499.78
45min12145769-214576999.59499.460.90100.58100.420.91
22142369-214236999.436100.40
32156279-2156279100.082101.04
42151184-215118499.846100.81
52105703-210570397.73598.63
62156350-2156350100.085101.03
60min12148355-214835599.71499.660.81100.92100.840.82
22148461-214846199.719100.90
32152688-215268899.915101.09
42150665-215066599.821101.01
52115355-211535598.18399.30
62168207-2168207100.636101.81
极限12155508-2155508100.04699.640.97101.47101.040.98
22149532-214953299.769101.18
32152907-215290799.926101.32
42146800-214680099.642101.05
52107505-210750597.81899.15
62168698-2168698100.658102.05
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