布瑞哌唑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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369694397068965929665196824968160.21
211.299697197534972520.41
单位质量响应值RSD%判断
8522.548613.990.76数据可信
供试品溶液-25062301批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min150288-5028852.55952.287.2252.5652.287.22
254399-5439956.85656.86
346176-4617648.26248.26
447322-4732249.45949.46
547639-4763949.79149.79
654282-5428256.73456.73
15min158930-5893061.59260.602.3961.8860.892.41
259454-5945462.13962.46
355654-5565458.16858.44
458388-5838861.02561.30
557092-5709259.67159.95
658374-5837461.01061.33
30min166843-6684369.86268.331.8970.5068.961.89
265958-6595868.93769.60
363494-6349466.36266.95
466296-6629669.29069.90
564609-6460967.52768.14
665069-6506968.00868.66
45min170881-7088174.08273.441.1375.1074.451.14
270394-7039473.57374.62
368815-6881571.92372.88
471064-7106474.27475.27
570318-7031873.49474.48
670154-7015473.32374.35
60min175172-7517278.56776.661.6580.0078.071.64
272978-7297876.27477.73
371483-7148374.71276.07
473572-7357276.89578.31
573805-7380577.13878.53
673055-7305576.35577.79
90min176426-7642679.87879.511.4181.7581.351.41
275824-7582479.24981.13
374167-7416777.51779.29
477367-7736780.86182.70
576542-7654279.99981.82
676131-7613179.56981.43
120min180141-8014183.76181.771.4886.0784.051.47
277830-7783081.34583.66
376905-7690580.37882.58
478729-7872982.28584.57
578483-7848382.02884.29
677351-7735180.84583.15
极限180571-8057184.21083.141.5386.9985.871.52
279432-7943283.02085.79
377865-7786581.38284.03
480590-8059084.23086.97
580490-8049084.12586.85
678310-7831081.84784.60
布瑞哌唑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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369767297315977439778597623976280.20
211.299749797787976420.22
单位质量响应值RSD%判断
8594.018648.540.45数据可信
供试品溶液-25062301批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min153287-5328755.35055.754.8155.3555.754.81
257006-5700659.21359.21
353973-5397356.06356.06
454057-5405756.15056.15
549105-4910551.00651.01
654619-5461956.73456.73
15min157935-5793560.17860.091.3360.4960.401.33
259229-5922961.52261.85
358021-5802160.26860.58
457100-5710059.31159.62
557275-5727559.49359.78
657552-5755259.78060.10
30min164632-6463267.13568.111.8867.7868.751.88
266449-6644969.02269.69
367411-6741170.02170.67
464998-6499867.51568.16
564106-6410666.58867.20
665803-6580368.35169.00
45min168325-6832570.97172.831.7571.9973.851.74
271211-7121173.96875.02
371040-7104073.79174.83
469750-6975072.45173.47
569160-6916071.83872.82
671185-7118573.94174.97
60min173128-7312875.95976.471.4077.3777.901.41
274464-7446477.34778.81
374405-7440577.28678.73
472801-7280175.62077.04
572237-7223775.03476.42
674677-7467777.56879.01
90min176122-7612279.06979.901.2380.9081.751.23
278032-7803281.05382.95
377040-7704080.02381.90
475647-7564778.57680.42
576802-7680279.77681.58
677884-7788480.90082.77
120min178595-7859581.63881.811.4283.9184.111.43
280007-8000783.10585.45
379647-7964782.73185.05
477415-7741580.41282.69
577483-7748380.48382.73
679426-7942682.50184.82
极限178369-7836981.40382.491.6484.1385.241.63
280821-8082183.95086.76
380000-8000083.09885.88
477792-7779280.80483.53
578707-7870781.75584.44
680794-8079483.92286.70
布瑞哌唑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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369807098166978989765398016979610.21
211.299696597200970820.18
单位质量响应值RSD%判断
8623.338598.940.21数据可信
供试品溶液-25062302批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min145895-4589547.72856.928.2847.7356.928.28
255883-5588358.11558.11
358705-5870561.04961.05
454874-5487457.06557.07
557191-5719159.47559.47
655854-5585458.08558.08
15min154376-5437656.54854.592.7856.8154.902.73
252842-5284254.95255.28
351998-5199854.07554.41
449993-4999351.98952.31
552627-5262754.72955.06
653116-5311655.23755.56
30min161854-6185464.32460.024.1064.9060.644.04
256628-5662858.88959.52
359013-5901361.37062.01
455306-5530657.51558.12
556340-5634058.59059.22
657175-5717559.45860.09
45min165631-6563168.25264.443.2269.1965.393.17
261441-6144163.89564.85
362573-6257365.07266.05
460220-6022062.62563.55
561548-6154864.00664.97
660368-6036862.77963.74
60min167900-6790070.61266.953.1271.9368.263.08
263504-6350466.04067.35
365587-6558768.20669.55
462639-6263965.14066.41
563676-6367666.21967.53
662983-6298365.49866.81
90min170362-7036273.17269.373.1974.8871.053.15
266030-6603068.66770.34
368112-6811270.83272.55
464743-6474367.32968.96
565334-6533467.94369.63
665669-6566968.29169.96
120min171234-7123474.07970.353.4776.1972.423.42
267770-6777070.47672.54
369554-6955472.33274.45
465767-6576768.39370.40
565325-6532567.93469.99
666226-6622668.87170.92
极限172435-7243575.32871.143.6577.8573.603.59
267802-6780270.51072.96
369744-6974472.52975.05
464963-6496367.55769.95
567758-6775870.46472.90
667774-6777470.48172.92
布瑞哌唑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(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369812498279983259830598092982250.12
211.299798497615978000.27
单位质量响应值RSD%判断
8646.578662.530.14数据可信
供试品溶液-25062302批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min157302-5730259.29157.167.7359.2957.167.73
246744-4674448.36748.37
356190-5619058.14158.14
457032-5703259.01259.01
555716-5571657.65057.65
658459-5845960.48960.49
15min148434-4843450.11552.002.8050.4452.312.80
248789-4878950.48350.75
351162-5116252.93853.26
450029-5002951.76652.09
551854-5185453.65453.97
651235-5123553.01453.35
30min153944-5394455.81756.423.3656.4257.033.28
256905-5690558.88159.43
355137-5513757.05157.67
455059-5505956.97057.59
554781-5478156.68357.30
651365-5136553.14853.78
45min158992-5899261.04061.092.2361.9662.012.20
259173-5917361.22762.10
359657-5965761.72862.66
460804-6080462.91563.85
558842-5884260.88561.82
656784-5678458.75559.68
60min159497-5949761.56363.012.2862.8264.272.26
260904-6090463.01864.23
361581-6158163.71965.00
463172-6317265.36566.65
560748-6074862.85764.13
659478-5947861.54362.80
90min163409-6340965.61065.593.1267.2167.203.07
262941-6294165.12666.69
365705-6570567.98669.62
465195-6519567.45869.10
562901-6290165.08566.71
660165-6016562.25463.85
120min164951-6495167.20668.582.5369.1770.552.48
267180-6718069.51271.44
366379-6637968.68370.69
469124-6912471.52473.54
564718-6471866.96568.95
665326-6532667.59469.53
极限167711-6771170.06269.921.5172.4072.281.51
267052-6705269.38071.69
368669-6866971.05373.44
468814-6881471.20373.62
566975-6697569.30071.65
666231-6623168.53070.85
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