布瑞哌唑口服液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2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%
111.139381994035939689392893940939380.09
211.149467294742947070.06
单位质量响应值RSD%判断
8440.078501.530.52数据可信
供试品溶液-25052101批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159057-5905762.43462.922.6662.4362.922.66
256992-5699260.25160.25
360005-6000563.43663.44
461420-6142064.93264.93
560778-6077864.25364.25
658838-5883862.20262.20
10min169450-6945073.42174.031.3473.5274.141.34
268548-6854872.46772.57
369797-6979773.78873.89
470832-7083274.88274.99
570586-7058674.62274.73
670954-7095475.01175.11
15min173082-7308277.26078.041.0977.4978.271.09
274195-7419578.43778.66
375139-7513979.43579.66
473761-7376177.97878.21
572923-7292377.09277.32
673839-7383978.06178.29
20min177046-7704681.45179.313.3981.8179.673.38
270799-7079974.84775.20
375455-7545579.76980.13
477356-7735681.77982.14
573243-7324377.43177.79
676248-7624880.60780.97
30min179543-7954384.09183.771.8484.5884.261.82
280826-8082685.44785.92
380378-8037884.97485.47
478528-7852883.01883.52
576772-7677281.16181.65
679401-7940183.94184.43
45min181570-8157086.23486.052.2986.8686.682.27
283089-8308987.84088.46
381686-8168686.35686.99
482645-8264587.37088.01
581544-8154486.20686.83
677825-7782582.27582.91
60min185504-8550490.39388.402.5491.1789.172.52
285992-8599290.90991.67
384568-8456889.40390.18
480626-8062685.23686.02
581800-8180086.47787.24
683216-8321687.97488.74
极限184200-8420089.01489.332.0689.9490.252.05
286421-8642191.36292.28
384334-8433489.15690.08
486638-8663891.59292.52
583119-8311987.87188.78
682298-8229887.00387.92
布瑞哌唑口服液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2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%
111.139341593955935739329193491935450.27
211.149334393008931760.26
单位质量响应值RSD%判断
8404.768364.090.35数据可信
供试品溶液-25052102批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154589-5458958.30458.623.4858.3058.623.48
254734-5473458.45958.46
356700-5670060.55960.56
451365-5136554.86154.86
556169-5616959.99259.99
655769-5576959.56559.56
10min165710-6571070.18270.991.8170.2871.081.81
267395-6739571.98272.08
368406-6840673.06273.16
465335-6533569.78269.87
565644-6564470.11270.21
666298-6629870.81070.91
15min172175-7217577.08775.912.4777.3076.122.46
269408-6940874.13274.35
372669-7266977.61577.84
468362-6836273.01573.22
572073-7207376.97877.19
671724-7172476.60576.82
20min175306-7530680.43178.571.7980.7778.911.77
274152-7415279.19979.54
373470-7347078.47078.82
474067-7406779.10879.44
572972-7297277.93878.28
671420-7142076.28176.63
30min181620-8162087.17581.447.4187.6581.917.37
265799-6579970.27770.75
379493-7949384.90385.39
478508-7850883.85184.31
577715-7771583.00483.48
674341-7434179.40079.87
45min186434-8643492.31788.172.7092.9488.782.69
282717-8271788.34788.94
383358-8335889.03189.66
481103-8110386.62387.22
581592-8159287.14587.76
680115-8011585.56786.17
60min186125-8612591.98690.605.5692.7691.355.51
285957-8595791.80792.54
378358-7835883.69184.46
485432-8543291.24691.99
581056-8105686.57287.33
692012-9201298.27499.02
极限185775-8577591.61375.7749.0492.5476.6848.45
286235-8623592.10492.99
386734-8673492.63793.55
483097-8309788.75289.65
583821-8382189.52690.43
6-0.0000.91
布瑞哌唑口服液项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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5000
标示量(mg)2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%
111.139262393133927749321093282930040.32
211.149339293769935800.29
单位质量响应值RSD%判断
8356.158400.360.38数据可信
供试品溶液-25052103批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148745-4874552.10151.804.9152.1051.804.91
248163-4816351.47951.48
351708-5170855.26855.27
450078-5007853.52653.53
547292-4729250.54850.55
644784-4478447.86747.87
10min160742-6074264.92465.792.5265.0165.872.51
261626-6162665.86965.95
359304-5930463.38763.48
462463-6246366.76366.85
561308-6130865.52965.61
663862-6386268.25968.34
15min165048-6504869.52670.691.2769.7270.881.26
265889-6588970.42570.62
367601-6760172.25572.45
465882-6588270.41870.62
566312-6631270.87771.07
666067-6606770.61570.81
20min168762-6876273.49672.812.5073.8173.122.49
268282-6828272.98373.30
370352-7035275.19575.51
466763-6676371.35971.68
568969-6896973.71774.03
665573-6557370.08770.40
30min172925-7292577.94676.333.0778.3876.763.05
271627-7162776.55876.99
373157-7315778.19478.64
471098-7109875.99376.43
567240-6724071.86972.30
672436-7243677.42377.85
45min174798-7479879.94880.720.7280.5181.280.71
275578-7557880.78181.34
376326-7632681.58182.15
475099-7509980.26980.83
575477-7547780.67381.23
675823-7582381.04381.60
60min179553-7955385.03083.301.9685.7384.001.95
279464-7946484.93585.63
378038-7803883.41184.12
478274-7827483.66384.36
576298-7629881.55182.24
675967-7596781.19781.89
极限175348-7534880.53583.503.7481.3784.333.70
281072-8107286.65387.49
381633-8163387.25388.10
477069-7706982.37583.21
578937-7893784.37185.20
674658-7465879.79880.63
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