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%
111.088232182179823718259682307823550.19
2 10.968247381995822340.42
单位质量响应值RSD%判断
7432.767503.100.67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%
10min1-0.0007.3276.300.007.3276.31
23321-33213.9823.98
311758-1175814.10014.10
47131-71318.5518.55
510957-1095713.13913.14
63470-34704.1614.16
15min153531-5353164.19265.282.6564.1965.322.68
253732-5373264.43364.46
354253-5425365.05865.14
456860-5686068.18468.23
555352-5535266.37666.45
652909-5290963.44663.47
30min161895-6189574.22273.142.9374.5873.542.93
258225-5822569.82170.20
360430-6043072.46572.90
461556-6155673.81574.24
563505-6350576.15276.59
660323-6032372.33772.71
45min168846-6884682.55779.642.0683.3380.452.03
265723-6572378.81279.58
365139-6513978.11278.95
466979-6697980.31881.15
566392-6639279.61480.48
665404-6540478.42979.21
60min169182-6918282.96082.751.6484.1984.001.59
270003-7000383.94485.15
369162-6916282.93684.21
466798-6679880.10181.38
569527-6952783.37484.68
669386-6938683.20484.42
90min172231-7223186.61685.882.1288.3087.592.09
273131-7313187.69589.37
372864-7286487.37589.11
470428-7042884.45486.18
571833-7183386.13987.91
669211-6921182.99584.67
120min175063-7506390.01287.951.9092.1890.141.83
274963-7496389.89292.05
373006-7300687.54589.77
471889-7188986.20688.40
571985-7198586.32188.57
673151-7315187.71989.86
极限175330-7533090.33288.112.1393.0090.792.07
274431-7443189.25491.91
374187-7418788.96291.67
470841-7084184.94987.62
572997-7299787.53590.26
673091-7309187.64790.27
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%
111.088345583134836538375583470834930.29
2 10.968222682111821680.10
单位质量响应值RSD%判断
7535.477497.080.37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%
10min117453-1745320.79411.5063.9220.7911.5063.92
22929-29293.4903.49
33527-35274.2024.20
415542-1554218.51718.52
511647-1164713.87613.88
66816-68168.1218.12
15min151645-5164561.53160.287.2161.6560.347.26
246048-4604854.86354.88
346368-4636855.24455.27
455086-5508665.63165.73
551328-5132861.15361.23
653073-5307363.23263.28
30min159186-5918670.51672.262.3770.9772.662.37
260887-6088772.54272.87
358819-5881970.07870.41
460928-6092872.59173.06
561403-6140373.15773.57
662674-6267474.67175.07
45min161715-6171573.52975.214.1974.3876.014.18
262056-6205673.93574.66
360209-6020971.73472.45
463359-6335975.48776.36
563508-6350875.66576.49
667922-6792280.92481.74
60min166268-6626878.95378.555.8880.2179.775.78
268391-6839181.48382.62
365206-6520677.68878.81
466414-6641479.12780.42
558958-5895870.24471.49
670333-7033383.79685.06
90min171006-7100684.59882.202.4886.2983.852.51
268520-6852081.63683.23
366360-6636079.06380.61
469716-6971683.06184.79
567997-6799781.01382.65
670355-7035583.82385.55
120min171071-7107184.67685.191.9886.8487.301.99
272826-7282686.76788.81
368893-6889382.08184.07
472134-7213485.94288.13
571651-7165185.36787.45
672426-7242686.29088.48
极限173913-7391388.06286.022.0590.7088.602.04
273501-7350187.57190.10
369934-6993483.32185.77
471809-7180985.55588.22
571348-7134885.00687.56
672665-7266586.57589.25
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%
111.088257082288820618232682473823440.24
2 10.968226981756820120.45
单位质量响应值RSD%判断
7431.777482.850.49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%
10min152476-5247663.01665.124.7863.0265.124.78
253688-5368864.47164.47
350804-5080461.00861.01
457333-5733368.84868.85
557185-5718568.67168.67
653894-5389464.71964.72
15min158890-5889070.71871.403.4771.0771.763.47
256090-5609067.35667.71
358578-5857870.34370.68
461877-6187774.30574.69
560923-6092373.15973.54
660365-6036572.48972.85
30min156941-5694168.37871.035.1769.1271.795.13
256238-5623867.53368.27
357800-5780069.40970.14
462625-6262575.20376.00
557908-5790869.53970.33
663367-6336776.09476.86
45min162300-6230074.81378.895.2475.9480.045.20
260851-6085173.07374.18
366245-6624579.55080.67
469652-6965283.64284.85
568316-6831682.03783.21
666795-6679580.21181.40
60min165234-6523478.33678.606.1179.8780.196.02
262465-6246575.01176.52
367714-6771481.31482.87
471649-7164986.04087.72
560225-6022572.32173.95
665441-6544178.58580.22
90min168895-6889582.73384.355.9984.7186.375.93
263504-6350476.25978.19
368855-6885582.68484.69
475552-7555290.72792.88
573412-7341288.15790.19
671209-7120985.51187.58
120min169156-6915683.04686.985.3285.4889.485.28
267133-6713380.61782.97
372066-7206686.54089.01
476764-7676492.18294.84
576439-7643991.79294.31
673056-7305687.72990.27
极限170250-7025084.36087.455.0487.2590.435.00
268042-6804281.70884.51
373101-7310187.78390.73
477600-7760093.18696.36
576452-7645291.80794.84
671508-7150885.87088.90
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%
111.088187682250824808187382224821410.32
2 10.968217582300822380.11
单位质量响应值RSD%判断
7413.457503.470.86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%
10min150548-5054860.69363.467.6160.6963.467.61
255945-5594567.17367.17
351074-5107461.32461.32
447081-4708156.53056.53
558032-5803269.67969.68
654443-5444365.36965.37
15min157144-5714468.61275.4221.3668.9575.7721.26
260222-6022272.30872.68
389323-89323107.250107.59
451117-5111761.37661.69
559282-5928271.18071.57
659798-5979871.79972.16
30min160124-6012472.19171.545.8872.9172.315.87
260785-6078572.98473.76
359368-5936871.28372.22
453199-5319963.87664.53
560146-6014672.21773.00
663865-6386576.68277.44
45min163147-6314775.82075.916.0576.9477.086.05
264548-6454877.50278.68
363585-6358576.34677.68
455837-5583767.04368.05
565936-6593679.16980.35
666270-6627079.57080.76
60min166244-6624479.53978.315.8781.0879.905.87
266375-6637579.69681.31
365727-6572778.91880.67
457894-5789469.51370.90
565800-6580079.00680.63
669274-6927483.17784.81
90min169003-6900382.85181.227.2384.8383.257.20
269442-6944283.37985.43
367545-6754581.10183.30
458100-5810069.76071.53
569835-6983583.85085.91
671953-7195386.39488.49
120min169926-6992683.96082.577.7286.4085.047.67
268843-6884382.65985.18
369433-6943383.36886.01
458671-5867170.44672.60
571569-7156985.93288.46
674151-7415189.03391.60
极限168238-6823881.93385.9610.8484.8488.9010.66
273364-7336488.08891.06
371739-7173986.13789.25
460115-6011572.18074.73
572083-7208386.55089.56
684013-84013100.874103.94
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