对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308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100
标示量(mg)96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%
1 12.973110333310963031125093108923310566331094120.09
2 12.923113728310999231118600.09
单位质量响应值RSD%判断
239738.78240856.040.33数据可信
供试品溶液-25121601批-布洛芬-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%
5min12274633-227463388.65584.593.8588.6584.583.86
22265687-226568788.30688.31
32071411-207141180.73480.73
42102910-210291081.96281.96
52149872-214987283.79283.79
62156865-215686584.06584.06
10min12383816-238381692.91088.683.6893.4089.143.68
22363317-236331792.11192.60
32172962-217296284.69285.14
42207871-220787186.05386.51
52263374-226337488.21688.68
62259800-225980088.07688.54
15min12420189-242018994.32890.843.0795.3491.803.08
22398929-239892993.49994.50
32242017-224201787.38388.30
42260589-226058988.10789.04
52335037-233503791.00991.96
62327719-232771990.72491.68
20min12432387-243238794.80391.753.0896.3493.223.08
22420710-242071094.34895.87
32254014-225401487.85189.26
42281978-228197888.94190.36
52368713-236871392.32193.78
62366518-236651892.23693.70
30min12418295-241829594.25491.792.9096.3193.762.91
22419175-241917594.28896.33
32262622-226262288.18690.08
42279287-227928788.83690.75
52371788-237178892.44194.42
62378994-237899492.72294.69
极限12407409-240740993.83091.623.0796.4194.113.07
22413756-241375694.07796.65
32260548-226054888.10690.49
42257577-225757787.99090.40
52380683-238068392.78895.28
62384558-238455892.93995.43
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312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50
标示量(mg)640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%
1 43.903497900349696234997093497973349075434966600.10
2 43.933498974349489834969360.09
单位质量响应值RSD%判断
79650.5779602.460.05数据可信
供试品溶液-25121601批-对乙酰氨基酚-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%
5min12702459-270245995.35993.462.5395.3693.472.53
22715760-271576095.82895.83
32548758-254875889.93589.94
42593597-259359791.51791.52
52640349-264034993.16793.17
62691771-269177194.98194.98
10min12731230-273123096.37494.072.6096.9094.582.60
22722162-272216296.05496.59
32566698-256669890.56891.07
42597645-259764591.66092.17
52666999-266699994.10794.62
62710324-271032495.63696.16
15min12721131-272113196.01793.742.3197.0894.782.31
22701489-270148995.32496.39
32570964-257096490.71991.72
42595387-259538791.58092.60
52654713-265471393.67494.71
62695153-269515395.10196.16
20min12710791-271079195.65393.342.6197.2594.902.61
22706430-270643095.49997.09
32544042-254404289.76991.28
42581853-258185391.10392.63
52644736-264473693.32294.88
62683993-268399394.70796.29
30min12681850-268185094.63192.762.2696.7694.842.27
22679833-267983394.56096.69
32537018-253701889.52191.53
42580851-258085191.06793.10
52626654-262665492.68494.76
62667170-266717094.11396.23
极限12662934-266293493.96492.052.5996.6294.652.59
22666617-266661794.09496.75
32517182-251718288.82191.32
42533529-253352989.39891.94
52615361-261536192.28594.88
62657306-265730693.76596.40
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308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100
标示量(mg)96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%
1 12.973108288309840231092183113072310922131076400.18
2 12.923123990311266031183250.26
单位质量响应值RSD%判断
239602.16241356.420.52数据可信
供试品溶液-25121701批-布洛芬-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%
5min12190325-219032585.30582.926.5285.3082.926.52
22374140-237414092.46492.46
32098722-209872281.73781.74
42019031-201903178.63478.63
51992687-199268777.60877.61
62100053-210005381.78981.79
10min12322848-232284890.46689.767.8490.9490.227.83
22654338-2654338103.376103.89
32217007-221700786.34486.80
42181761-218176184.97185.41
52174571-217457184.69185.12
62278057-227805788.72289.18
15min12375291-237529192.50992.323.9293.4993.283.95
22543581-254358199.063100.15
32302672-230267289.68090.61
42302948-230294889.69190.60
52310752-231075289.99590.90
62387684-238768492.99193.94
20min12369067-236906792.26693.734.2693.7695.204.28
22597273-2597273101.154102.79
32316061-231606190.20291.63
42342355-234235591.22692.63
52372424-237242492.39793.80
62442048-244204895.10896.57
30min12391038-239103893.12294.343.9095.1296.333.92
22585647-2585647100.701102.90
32335526-233552690.96092.89
42338967-233896791.09493.01
52411959-241195993.93795.85
62470462-247046296.21598.21
极限12376338-237633892.54994.614.3595.0797.124.35
22606392-2606392101.509104.27
32334359-233435990.91493.35
42330264-233026490.75593.17
52452365-245236595.51097.95
62475421-247542196.40898.93
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312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50
标示量(mg)640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%
1 43.903495815348439834959863499217349783734946510.17
2 43.933505410349227334988420.27
单位质量响应值RSD%判断
79604.8179645.850.04数据可信
供试品溶液-25121701批-对乙酰氨基酚-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%
5min12645027-264502793.33393.643.4093.3393.643.40
22818576-281857699.45799.46
32617550-261755092.36492.36
42545778-254577889.83189.83
52658692-265869293.81693.82
62636796-263679693.04393.04
10min12685241-268524194.75295.333.3895.2795.853.38
22859687-2859687100.908101.46
32639988-263998893.15693.67
42592779-259277991.49091.99
52726638-272663896.21396.73
62705864-270586495.48096.00
15min12683595-268359594.69495.492.9795.7496.542.97
22833375-283337599.979101.09
32645863-264586393.36394.39
42605876-260587691.95292.96
52743379-274337996.80497.86
62724339-272433996.13297.18
20min12640735-264073593.18295.363.8094.7596.943.79
22877579-2877579101.539103.21
32625268-262526892.63694.19
42601927-260192791.81393.33
52737891-273789196.61098.20
62730872-273087296.36397.94
30min12657140-265714093.76195.083.4195.8597.193.40
22839536-2839536100.197102.43
32625582-262558292.64794.71
42583727-258372791.17093.20
52727311-272731196.23798.37
62733223-273322396.44598.56
极限12637736-263773693.07694.583.7695.6997.223.75
22851769-2851769100.629103.42
32608263-260826392.03694.61
42567699-256769990.60593.14
52706623-270662395.50798.17
62710091-271009195.62998.28
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